TAAC: Investigation of the Role of Pictorial Asthma Action Plans to Promote Self-management in Rural Youth With Asthma
Sponsor
West Virginia University (Other)
Overall Status
Completed
CT.gov ID
NCT03187119
Collaborator
(none)
45
1
2
17.6
2.6
Study Details
Study Description
Brief Summary
The aim of this study is to investigate the potential benefit of Pictorial versus Written Asthma Action Plans (AAPs) to support asthma management among young people with persistent asthma. Participants will be randomly allocated to the Pictorial or Written AAP group and followed up over a 6-month period. Qualitative and quantitative data will be collected from young people, parents and clinical teams involved in recruitment to assess the feasibility and acceptability of the Pictorial AAP (PAAP) software developed for this study, the PAAPs produced by the software, and the study procedures.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Asthma is the most common chronic health condition of childhood, and continues to be associated with morbidity and mortality. Many children with persistent asthma follow a treatment plan including a prescription to take a daily inhaled corticosteroid (controller), often in conjunction with a daily oral controller medication, and a dose of an albuterol (rescue) inhaler before activity or exercise. Young people with asthma must add to this treatment plan in response to a flare in symptoms by taking additional medication and contacting their asthma provider or getting to a hospital. Adherence to daily medications is essential for maintaining lung health and reducing symptom flares, but asthma treatment is complex, requiring regular decision-making in response to symptoms and environmental issues like symptom triggers. As a result consistent adherence is a challenge for families and young people. It is recommended to provide an Asthma Action Plan (AAP) to all people diagnosed with asthma, summarizing their treatment plan using a traffic light format; Green Zone for daily, symptom-free management, Yellow Zone for symptom flare, and Red Zone for extreme symptom flare. Despite evidence for the effectiveness of AAPs, they are often not prescribed for reasons including readability and accessibility for families and young people, and asthma provider perceptions of their utility and suitability. In this study, young people with persistent asthma will be given a Written (WAAP) or Pictorial Asthma Action Plan (PAAP) to compare the differential impact on AAP knowledge, adherence to daily inhaler use, and asthma control. Software developed for the study, in collaboration with providers, young people with asthma and their parents, will be used to generate personalized PAAPs. Quantitative and qualitative data will be collected to explore perceptions of providers, parents and young people of different versions of AAPs, the influence of AAPs on asthma understanding and management, and the experience of taking part in the study, as well as to assess the impact of different AAPs on the asthma and psychosocial outcomes mentioned. The findings will inform the development of the PAAP software and as the basis for a definitive Randomized Controlled Trial of the efficacy of PAAPs.
Study Design
Study Type:
Interventional
Actual Enrollment
:
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Take Action for Asthma Control Study - Pilot Randomized Controlled Trial of Pictorial Asthma Action Plans to Promote Self-management and Health in Rural Youth With Asthma
Actual Study Start Date
:
May 24, 2017
Actual Primary Completion Date
:
Nov 12, 2018
Actual Study Completion Date
:
Nov 12, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pictorial Asthma Action Plan Young people in the Pictorial Asthma Action Plan (PAAP) arm will receive a PAAP generated by their asthma provider using a software program developed for the study. The PAAP will be personalized according to the young person's gender, race, favorite sport/activity, provider's gender, provider's clinic contact details, and hospital in emergency situations. The PAAP contains minimal text, instead illustrating each participant's asthma regimen using pictures, such as color-coded daily controller and rescue inhalers. Each participant will receive multiple copies of their PAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the PAAP. |
Behavioral: Pictorial Asthma Action Plan
Participants will receive a PAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their PAAP.
|
| Active Comparator: Written Asthma Action Plan Young people in the Written Asthma Action Plan (WAAP) arm will receive a WAAP generated by their asthma provider using using the National Heart, Lung, and Blood Institute (NHLBI) template. The WAAP will be personalized according to the young person's treatment plan. Each participant will receive multiple copies of their WAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the WAAP. |
Behavioral: Written Asthma Action Plan
Participants will receive a WAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their WAAP.
|
Outcome Measures
Primary Outcome Measures
- The Asthma Action Plan Knowledge Interview (AAPKI)-Child [Measured at three time points over 6 months; baseline, 3- and 6-month follow-up.]
The Asthma Action Plan Knowledge Interview (AAPKI) was developed for the purposes of this study. The first section of the structured interview included 8 items describing hypothetical situations in which the respondent was asked to categorize themselves or their child into one of three zones. These items were scored as correct (1) or incorrect (0). Two items were excluded because they were not relevant to all participants. The second section of the structured interview included 3 open response items asking the respondent to describe the treatment instructions for the three zones according to the AAP. Responses were coded on a 4-point scale: 0 = incorrect; 1 = possibly correct, but vague or missing important details; 2 = correct but not detailed; 3 = correct and specific. Percent correct knowledge scores were calculated using six items from the first section and the three additional questions about treatment, for a total of nine questions.
- The Asthma Action Plan Knowledge Interview (AAPKI)-Parent [Measured at three time points over 6 months; baseline, 3- and 6-month follow-up.]
The Asthma Action Plan Knowledge Interview (AAPKI) was developed for the purposes of this study. The first section of the structured interview included 8 items describing hypothetical situations in which the respondent was asked to categorize their child into one of three zones. These items were scored as correct (1) or incorrect (0). Two items were excluded because they were not relevant to all participants. The second section of the structured interview included 3 open response items asking the respondent to describe the treatment instructions for the three zones according to the AAP. Responses were coded on a 4-point scale: 0 = incorrect; 1 = possibly correct, but vague or missing important details; 2 = correct but not detailed; 3 = correct and specific. Percent correct knowledge scores were calculated using six items from the first section and the three additional questions about treatment, for a total of nine questions.
- Asthma Control Test [Measured at four time points over 6 months; baseline, 1-, 3- and 6-month follow-up.]
Asthma control was measures via the Asthma Control Test (ACT) 12 for participants 12 and older (7 items), and the ACT 11 for participants 11 and younger (5 items). These scales include a 5 point Likert type response. Total score is calculated by summing response with higher scores indicating more control. Possible range of scores is 0-35. The raw scores were dichotomized for a clinical cut-off, with a score of 19 and less considered "poor control".
- Adherence to Daily Controller Inhaler [Measured over 6 months; day 1, day 30, day 90 and day 180]
Adherence to daily controller inhaler measured objectively using an electronic monitor attached to the inhaler and connected to a smart phone application or 'hub' in the participant's home.Data was examined for daily percent adherence by comparing the number of puffs taken with the number of puffs prescribed. Day 180 was not included in the analyses due to low insufficient group size.
- Lung Function-FEV1 [Measured at three time points over 6 months; baseline, 3- and 6-month follow-up.]
Lung function was assessed using spirometry outcome of Forced Expiratory Volume (FEV1),
- Lung Function- FEF 25-75 [Measured at three time points over 6 months; baseline, 3- and 6-month follow-up.]
This data is gathered from a spirometry test. FEF 25-75 is the air flow between 25% and 75% of forced vital capacity.
Secondary Outcome Measures
- Satisfaction With Asthma Action Plan-Caregiver [Measured at two time points over 6 months; 1- and 6-month follow-up.]
Satisfaction questions were developed for this project and a final questionnaire developed. The Satisfaction questionnaire was completed by both parents and children at post-test (1 month, and 3 or 6 months). The scale included 11 questions, 5 reverse coded, on a 4 point Likert-type response scale. A mean item score was generated; higher scores indicate higher levels of satisfaction. Possible range of mean score was 0-4.
- Satisfaction With Asthma Action Plan-Patient [Measured at two time points over 6 months; 1- and 6-month follow-up.]
Satisfaction questions were developed for this project and a final questionnaire developed. The Satisfaction questionnaire was completed by both parents and children at post-test (1 month, and 3 or 6 months). The scale included 11 questions, 5 reverse coded, on a 4 point Likert-type response scale. Items were averaged together for a mean score; higher scores indicate higher levels of satisfaction. Possible range of mean score was 0-4.
Eligibility Criteria
Criteria
Ages Eligible for Study:
8 Years
to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
age 8-17 years
-
new patient (to clinic) with a diagnosis of persistent asthma or an established patient with uncontrolled persistent asthma and a clinical need for a new treatment regimen
-
no history of having received a written AAP
-
prescribed an inhaled corticosteroid (i.e., daily controller medication).
Exclusion Criteria:
-
patients and caregivers who do not use English as their primary language
-
has a significant developmental (e.g., autism, intellectual disability) or sensory (e.g., blindness) disorder that would preclude completion of study measures.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | WVU Medicine | Morgantown | West Virginia | United States | 26501 |
Sponsors and Collaborators
- West Virginia University
Investigators
- Principal Investigator: Christina Duncan, PhD, West Virginia University
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Christina Duncan,
Principal Investigator,
West Virginia University
ClinicalTrials.gov Identifier:
NCT03187119
Other Study ID Numbers:
- 1612396282
First Posted:
Jun 14, 2017
Last Update Posted:
Oct 22, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Christina Duncan,
Principal Investigator,
West Virginia University
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Pictorial Asthma Action Plan | Written Asthma Action Plan |
|---|---|---|
| Arm/Group Description | Young people in the Pictorial Asthma Action Plan (PAAP) arm will receive a PAAP generated by their asthma provider using a software program developed for the study. The PAAP will be personalized according to the young person's gender, race, favorite sport/activity, provider's gender, provider's clinic contact details, and hospital in emergency situations. The PAAP contains minimal text, instead illustrating each participant's asthma regimen using pictures, such as color-coded daily controller and rescue inhalers. Each participant will receive multiple copies of their PAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the PAAP. Pictorial Asthma Action Plan: Participants will receive a PAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their PAAP. | Young people in the Written Asthma Action Plan (WAAP) arm will receive a WAAP generated by their asthma provider using using the National Heart, Lung, and Blood Institute (NHLBI) template. The WAAP will be personalized according to the young person's treatment plan. Each participant will receive multiple copies of their WAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the WAAP. Written Asthma Action Plan: Participants will receive a WAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their WAAP. |
| Period Title: Overall Study | ||
| STARTED | 22 | 23 |
| COMPLETED | 20 | 18 |
| NOT COMPLETED | 2 | 5 |
Baseline Characteristics
| Arm/Group Title | Pictorial Asthma Action Plan | Written Asthma Action Plan | Total |
|---|---|---|---|
| Arm/Group Description | Young people in the Pictorial Asthma Action Plan (PAAP) arm will receive a PAAP generated by their asthma provider using a software program developed for the study. The PAAP will be personalized according to the young person's gender, race, favorite sport/activity, provider's gender, provider's clinic contact details, and hospital in emergency situations. The PAAP contains minimal text, instead illustrating each participant's asthma regimen using pictures, such as color-coded daily controller and rescue inhalers. Each participant will receive multiple copies of their PAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the PAAP. Pictorial Asthma Action Plan: Participants will receive a PAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their PAAP. | Young people in the Written Asthma Action Plan (WAAP) arm will receive a WAAP generated by their asthma provider using using the National Heart, Lung, and Blood Institute (NHLBI) template. The WAAP will be personalized according to the young person's treatment plan. Each participant will receive multiple copies of their WAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the WAAP. Written Asthma Action Plan: Participants will receive a WAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their WAAP. | Total of all reporting groups |
| Overall Participants | 22 | 23 | 45 |
| Age (Count of Participants) | |||
| <=18 years |
22
100%
|
23
100%
|
45
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
11.70
(2.91)
|
11.87
(2.65)
|
11.79
(2.75)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
13
59.1%
|
14
60.9%
|
27
60%
|
| Male |
9
40.9%
|
9
39.1%
|
18
40%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
21
95.5%
|
22
95.7%
|
43
95.6%
|
| More than one race |
1
4.5%
|
0
0%
|
1
2.2%
|
| Unknown or Not Reported |
0
0%
|
1
4.3%
|
1
2.2%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
22
100%
|
23
100%
|
45
100%
|
| Caregiver Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
40.00
(7.92)
|
42.26
(9.88)
|
41.16
(8.95)
|
| Parental Education (Count of Participants) | |||
| Less than High School |
3
13.6%
|
7
30.4%
|
10
22.2%
|
| More than High School |
19
86.4%
|
16
69.6%
|
35
77.8%
|
| Less than High School |
7
31.8%
|
11
47.8%
|
18
40%
|
| More than High School |
15
68.2%
|
12
52.2%
|
27
60%
|
| Caregiver Marital Status (Count of Participants) | |||
| Never Been Married / Single |
2
9.1%
|
0
0%
|
2
4.4%
|
| Married to other biological parent |
14
63.6%
|
13
56.5%
|
27
60%
|
| Living with boyfriend / girlfriend |
1
4.5%
|
2
8.7%
|
3
6.7%
|
| Divorced / Single |
0
0%
|
4
17.4%
|
4
8.9%
|
| Remarried to step-parent |
3
13.6%
|
2
8.7%
|
5
11.1%
|
| Widowed (other biological parent is deceased) |
1
4.5%
|
0
0%
|
1
2.2%
|
| Annual Household Income (Count of Participants) | |||
| Less than $15,000 |
3
13.6%
|
2
8.7%
|
5
11.1%
|
| 15,000 - $29,999 |
2
9.1%
|
6
26.1%
|
8
17.8%
|
| $30,000 - $44,999 |
5
22.7%
|
3
13%
|
8
17.8%
|
| $45,000 - $59,999 |
2
9.1%
|
1
4.3%
|
3
6.7%
|
| $60,000 - $74,999 |
1
4.5%
|
4
17.4%
|
5
11.1%
|
| $75,000 and greater |
9
40.9%
|
6
26.1%
|
15
33.3%
|
| Child Prior Diagnosis of Asthma (Count of Participants) | |||
| Yes |
20
90.9%
|
19
82.6%
|
39
86.7%
|
| No |
2
9.1%
|
4
17.4%
|
6
13.3%
|
| Child Age of Diagnosis of Asthma (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
3.94
(2.93)
|
7.30
(1.38)
|
5.67
(4.07)
|
| Child Number of Relatives with Asthma Diagnosis (Count of Participants) | |||
| Yes |
18
81.8%
|
19
82.6%
|
37
82.2%
|
| No |
4
18.2%
|
4
17.4%
|
8
17.8%
|
| Child Immediate Relatives Asthma (Count of Participants) | |||
| Yes |
13
59.1%
|
15
65.2%
|
28
62.2%
|
| No |
9
40.9%
|
8
34.8%
|
17
37.8%
|
| Child Extended Relatives Asthma (Count of Participants) | |||
| Yes |
13
59.1%
|
16
69.6%
|
29
64.4%
|
| No |
9
40.9%
|
7
30.4%
|
16
35.6%
|
| Child Grade (Count of Participants) | |||
| Elementary (1-4) |
7
31.8%
|
6
26.1%
|
13
28.9%
|
| Middle (5-8) |
9
40.9%
|
12
52.2%
|
21
46.7%
|
| High (9-12) |
6
27.3%
|
5
21.7%
|
11
24.4%
|
| Child Special Education (Count of Participants) | |||
| Yes |
4
18.2%
|
7
30.4%
|
11
24.4%
|
| No |
18
81.8%
|
16
69.6%
|
34
75.6%
|
| Child Illness Comorbidity (Count of Participants) | |||
| Yes |
16
72.7%
|
11
47.8%
|
27
60%
|
| No |
6
27.3%
|
12
52.2%
|
18
40%
|
| Child Insurance Provider (Count of Participants) | |||
| Medicaid |
19
86.4%
|
18
78.3%
|
37
82.2%
|
| Private |
2
9.1%
|
3
13%
|
5
11.1%
|
| None |
0
0%
|
0
0%
|
0
0%
|
| Asthma Control Test (Count of Participants) | |||
| Above Clinical Cut Off (>19) |
11
50%
|
7
30.4%
|
18
40%
|
| Below Clinical Cut Off (>19) |
11
50%
|
16
69.6%
|
27
60%
|
| Forced Expiratory Volume (FEV)1 (percentage of predicted FEV1 value) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [percentage of predicted FEV1 value] |
2.39
(0.86)
|
2.32
(0.62)
|
2.36
(0.75)
|
| Forced Expiratory Flow (FEF) 25-75 (percent predicted) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [percent predicted] |
2.29
(0.95)
|
2.26
(0.68)
|
2.28
(0.81)
|
| The Asthma Action Plan Knowledge Interview (AAPKI)-Parent (Average percent correct) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Average percent correct] |
72.72
(17.39)
|
71.50
(14.14)
|
72.10
(15.65)
|
| The Asthma Action Plan Knowledge Interview (AAPKI)-Child (Average percent correct) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Average percent correct] |
73.73
(17.67)
|
58.94
(19.66)
|
66.17
(19.95)
|
| Wechsler Individual Achievement Test-III (age-based percentile rank) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [age-based percentile rank] |
97.14
(10.8)
|
95.22
(22)
|
96.16
(17.25)
|
| Test of Functional Health Literacy in Adults (TOFHLA) (units on a scale) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [units on a scale] |
35
|
35
|
35
|
| Test of Functional Health Literacy (Child) (units on a scale) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [units on a scale] |
34.5
|
34
|
34
|
| Asthma Numeracy Questionnaire (units on a scale) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [units on a scale] |
3.5
|
4
|
4
|
Outcome Measures
| Title | The Asthma Action Plan Knowledge Interview (AAPKI)-Child |
|---|---|
| Description | The Asthma Action Plan Knowledge Interview (AAPKI) was developed for the purposes of this study. The first section of the structured interview included 8 items describing hypothetical situations in which the respondent was asked to categorize themselves or their child into one of three zones. These items were scored as correct (1) or incorrect (0). Two items were excluded because they were not relevant to all participants. The second section of the structured interview included 3 open response items asking the respondent to describe the treatment instructions for the three zones according to the AAP. Responses were coded on a 4-point scale: 0 = incorrect; 1 = possibly correct, but vague or missing important details; 2 = correct but not detailed; 3 = correct and specific. Percent correct knowledge scores were calculated using six items from the first section and the three additional questions about treatment, for a total of nine questions. |
| Time Frame | Measured at three time points over 6 months; baseline, 3- and 6-month follow-up. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., attrition, incomplete measures). |
| Arm/Group Title | Pictorial Asthma Action Plan | Written Asthma Action Plan |
|---|---|---|
| Arm/Group Description | Young people in the Pictorial Asthma Action Plan (PAAP) arm will receive a PAAP generated by their asthma provider using a software program developed for the study. The PAAP will be personalized according to the young person's gender, race, favorite sport/activity, provider's gender, provider's clinic contact details, and hospital in emergency situations. The PAAP contains minimal text, instead illustrating each participant's asthma regimen using pictures, such as color-coded daily controller and rescue inhalers. Each participant will receive multiple copies of their PAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the PAAP. Pictorial Asthma Action Plan: Participants will receive a PAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their PAAP. | Young people in the Written Asthma Action Plan (WAAP) arm will receive a WAAP generated by their asthma provider using using the National Heart, Lung, and Blood Institute (NHLBI) template. The WAAP will be personalized according to the young person's treatment plan. Each participant will receive multiple copies of their WAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the WAAP. Written Asthma Action Plan: Participants will receive a WAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their WAAP. |
| Measure Participants | 22 | 23 |
| 3 Month Assessment |
76.11
(20.16)
|
61.40
(11.33)
|
| 6 Month Assessment |
77.08
(17.90)
|
62.09
(11.15)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pictorial Asthma Action Plan, Written Asthma Action Plan |
|---|---|---|
| Comments | The reference group for this model is the Pictorial Asthma Action Plan Group. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.42 |
| Comments | The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction. | |
| Method | linear mixed model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | 1.41 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pictorial Asthma Action Plan, Written Asthma Action Plan |
|---|---|---|
| Comments | The reference group for this analysis is the Pictorial Asthma Action Plan group. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.03 |
| Comments | The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction. | |
| Method | multiple linear regression. | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | -14.31 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pictorial Asthma Action Plan, Written Asthma Action Plan |
|---|---|---|
| Comments | The reference group for this analysis is the Pictorial Asthma Action Plan group. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.89 |
| Comments | The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of group and time. | |
| Method | multiple linear regression. | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | -0.33 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | The Asthma Action Plan Knowledge Interview (AAPKI)-Parent |
|---|---|
| Description | The Asthma Action Plan Knowledge Interview (AAPKI) was developed for the purposes of this study. The first section of the structured interview included 8 items describing hypothetical situations in which the respondent was asked to categorize their child into one of three zones. These items were scored as correct (1) or incorrect (0). Two items were excluded because they were not relevant to all participants. The second section of the structured interview included 3 open response items asking the respondent to describe the treatment instructions for the three zones according to the AAP. Responses were coded on a 4-point scale: 0 = incorrect; 1 = possibly correct, but vague or missing important details; 2 = correct but not detailed; 3 = correct and specific. Percent correct knowledge scores were calculated using six items from the first section and the three additional questions about treatment, for a total of nine questions. |
| Time Frame | Measured at three time points over 6 months; baseline, 3- and 6-month follow-up. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., attrition, incomplete measures). |
| Arm/Group Title | Pictorial Asthma Action Plan | Written Asthma Action Plan |
|---|---|---|
| Arm/Group Description | Young people in the Pictorial Asthma Action Plan (PAAP) arm will receive a PAAP generated by their asthma provider using a software program developed for the study. The PAAP will be personalized according to the young person's gender, race, favorite sport/activity, provider's gender, provider's clinic contact details, and hospital in emergency situations. The PAAP contains minimal text, instead illustrating each participant's asthma regimen using pictures, such as color-coded daily controller and rescue inhalers. Each participant will receive multiple copies of their PAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the PAAP. Pictorial Asthma Action Plan: Participants will receive a PAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their PAAP. | Young people in the Written Asthma Action Plan (WAAP) arm will receive a WAAP generated by their asthma provider using using the National Heart, Lung, and Blood Institute (NHLBI) template. The WAAP will be personalized according to the young person's treatment plan. Each participant will receive multiple copies of their WAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the WAAP. Written Asthma Action Plan: Participants will receive a WAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their WAAP. |
| Measure Participants | 22 | 23 |
| 3 Month Assessment |
74.44
(16.95)
|
69.59
(13.78)
|
| 6 Month Assessment |
63.89
(14.91)
|
65.28
(10.64)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pictorial Asthma Action Plan, Written Asthma Action Plan |
|---|---|---|
| Comments | The reference group for this analysis is the Pictorial Asthma Action Plan group. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.31 |
| Comments | The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction. | |
| Method | multiple linear regression. | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | -1.59 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pictorial Asthma Action Plan, Written Asthma Action Plan |
|---|---|---|
| Comments | The reference for group for this analysis is the Pictorial Asthma Action Plan group. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.73 |
| Comments | The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction. | |
| Method | multiple linear regression. | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | 1.90 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pictorial Asthma Action Plan, Written Asthma Action Plan |
|---|---|---|
| Comments | The reference for group for this analysis is the Pictorial Asthma Action Plan group. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.92 |
| Comments | The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of group and time. | |
| Method | multiple linear regression. | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | -0.21 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Asthma Control Test |
|---|---|
| Description | Asthma control was measures via the Asthma Control Test (ACT) 12 for participants 12 and older (7 items), and the ACT 11 for participants 11 and younger (5 items). These scales include a 5 point Likert type response. Total score is calculated by summing response with higher scores indicating more control. Possible range of scores is 0-35. The raw scores were dichotomized for a clinical cut-off, with a score of 19 and less considered "poor control". |
| Time Frame | Measured at four time points over 6 months; baseline, 1-, 3- and 6-month follow-up. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., attrition, incomplete measures). |
| Arm/Group Title | Pictorial Asthma Action Plan | Written Asthma Action Plan |
|---|---|---|
| Arm/Group Description | Young people in the Pictorial Asthma Action Plan (PAAP) arm will receive a PAAP generated by their asthma provider using a software program developed for the study. The PAAP will be personalized according to the young person's gender, race, favorite sport/activity, provider's gender, provider's clinic contact details, and hospital in emergency situations. The PAAP contains minimal text, instead illustrating each participant's asthma regimen using pictures, such as color-coded daily controller and rescue inhalers. Each participant will receive multiple copies of their PAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the PAAP. Pictorial Asthma Action Plan: Participants will receive a PAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their PAAP. | Young people in the Written Asthma Action Plan (WAAP) arm will receive a WAAP generated by their asthma provider using using the National Heart, Lung, and Blood Institute (NHLBI) template. The WAAP will be personalized according to the young person's treatment plan. Each participant will receive multiple copies of their WAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the WAAP. Written Asthma Action Plan: Participants will receive a WAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their WAAP. |
| Measure Participants | 22 | 23 |
| Above ACT cut-off (>19) |
19
86.4%
|
11
47.8%
|
| Below ACT cut-off (>19) |
3
13.6%
|
11
47.8%
|
| Above ACT cut-off (>19) |
17
77.3%
|
16
69.6%
|
| Below ACT cut-off (>19) |
3
13.6%
|
3
13%
|
| Above ACT cut-off (>19) |
12
54.5%
|
13
56.5%
|
| Below ACT cut-off (>19) |
4
18.2%
|
4
17.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pictorial Asthma Action Plan, Written Asthma Action Plan |
|---|---|---|
| Comments | The reference for group for this analysis is the Pictorial Asthma Action Plan group. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.06 |
| Comments | The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction. | |
| Method | generalized linear mixed model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | 0.52 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pictorial Asthma Action Plan, Written Asthma Action Plan |
|---|---|---|
| Comments | The reference for group for this analysis is the Pictorial Asthma Action Plan group. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.07 |
| Comments | The results listed here are for the main effect of group. Please see Analyses 1 and 2 for the main effect of group and the time x group interaction. | |
| Method | generalized linear mixed model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | -1.57 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pictorial Asthma Action Plan, Written Asthma Action Plan |
|---|---|---|
| Comments | The reference for group for this analysis is the Pictorial Asthma Action Plan group. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.33 |
| Comments | The results listed here are for the time x group interaction. Please see Analyses 2 and 3 for the main effects of group and time. | |
| Method | generalized linear mixed model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | 0.37 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Adherence to Daily Controller Inhaler |
|---|---|
| Description | Adherence to daily controller inhaler measured objectively using an electronic monitor attached to the inhaler and connected to a smart phone application or 'hub' in the participant's home.Data was examined for daily percent adherence by comparing the number of puffs taken with the number of puffs prescribed. Day 180 was not included in the analyses due to low insufficient group size. |
| Time Frame | Measured over 6 months; day 1, day 30, day 90 and day 180 |
Outcome Measure Data
| Analysis Population Description |
|---|
| For this pilot program, prescription dose was not used for randomization into group. Only one participant had 1 puff per day; all other participants had 2 or 4. Thus, this participant taking only one per day was excluded from adherence analysis. |
| Arm/Group Title | Pictorial Asthma Action Plan | Written Asthma Action Plan |
|---|---|---|
| Arm/Group Description | Young people in the Pictorial Asthma Action Plan (PAAP) arm will receive a PAAP generated by their asthma provider using a software program developed for the study. The PAAP will be personalized according to the young person's gender, race, favorite sport/activity, provider's gender, provider's clinic contact details, and hospital in emergency situations. The PAAP contains minimal text, instead illustrating each participant's asthma regimen using pictures, such as color-coded daily controller and rescue inhalers. Each participant will receive multiple copies of their PAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the PAAP. Pictorial Asthma Action Plan: Participants will receive a PAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their PAAP. | Young people in the Written Asthma Action Plan (WAAP) arm will receive a WAAP generated by their asthma provider using using the National Heart, Lung, and Blood Institute (NHLBI) template. The WAAP will be personalized according to the young person's treatment plan. Each participant will receive multiple copies of their WAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the WAAP. Written Asthma Action Plan: Participants will receive a WAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their WAAP. |
| Measure Participants | 21 | 23 |
| Day 1: 2x per day prescription |
50
|
75
|
| Day 1: 4x per day prescription |
50
|
50
|
| Day 30: 2x per day prescription |
50
|
100
|
| Day 30: 4x per day prescription |
87.5
|
50
|
| Day 90: 2x per day prescription |
25
|
0
|
| Day 90: 4x per day prescription |
50
|
25
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pictorial Asthma Action Plan, Written Asthma Action Plan |
|---|---|---|
| Comments | The reference group for this analysis is the Pictorial Asthma Action Plan group. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .002 |
| Comments | The results listed here are for the main effect of time. Please see Analyses 2-3 for the main effects of time and prescription and Analyses 4-6 for interactions. | |
| Method | generalized linear mixed model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | -0.01 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The analyses are modeling lower adherence. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pictorial Asthma Action Plan, Written Asthma Action Plan |
|---|---|---|
| Comments | The reference group for this analysis is the Pictorial Asthma Action Plan group. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.07 |
| Comments | The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effects of time and prescription and Analyses 4-6 for interactions. | |
| Method | generalized linear mixed model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | -0.16 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The analyses are modeling lower adherence. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pictorial Asthma Action Plan, Written Asthma Action Plan |
|---|---|---|
| Comments | The reference group for this analysis is the Pictorial Asthma Action Plan group. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .69 |
| Comments | The results listed here are for the main effect of prescription. Please see Analyses 1-2 for the main effects of time and group and Analyses 4-6 for interactions. | |
| Method | generalized linear mixed model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | 0.43 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The analyses are modeling lower adherence. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pictorial Asthma Action Plan, Written Asthma Action Plan |
|---|---|---|
| Comments | The reference group for this analysis is the Pictorial Asthma Action Plan group. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.37 |
| Comments | The results listed here are for the time x group interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 5-7 for other interactions. | |
| Method | generalized linear mixed model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | 0.02 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The analyses are modeling lower adherence. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pictorial Asthma Action Plan, Written Asthma Action Plan |
|---|---|---|
| Comments | The reference group for this analysis is the Pictorial Asthma Action Plan group. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.12 |
| Comments | The results listed here are for the prescription x group interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 4 and 6 for other interactions. | |
| Method | generalized linear mixed model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | -1.14 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The analyses are modeling lower adherence. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pictorial Asthma Action Plan |
|---|---|---|
| Comments | The reference groups for this analysis is the 2x per day group. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.006 |
| Comments | The results listed here are for the time x PAAP group x prescription interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 4-5 for interactions. | |
| Method | generalized linear mixed model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | 0.01 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The analyses are modeling lower adherence. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Written Asthma Action Plan |
|---|---|---|
| Comments | The reference group for this analysis is 2x per day group. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.006 |
| Comments | The results listed here are for the time x WAAP group x prescription interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 4-5 for interactions. | |
| Method | generalized linear mixed model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | 0.04 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | These analyses are modeling lower adherence. | |
| Title | Lung Function-FEV1 |
|---|---|
| Description | Lung function was assessed using spirometry outcome of Forced Expiratory Volume (FEV1), |
| Time Frame | Measured at three time points over 6 months; baseline, 3- and 6-month follow-up. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., equipment difficulties). |
| Arm/Group Title | Pictorial Asthma Action Plan | Written Asthma Action Plan |
|---|---|---|
| Arm/Group Description | Young people in the Pictorial Asthma Action Plan (PAAP) arm will receive a PAAP generated by their asthma provider using a software program developed for the study. The PAAP will be personalized according to the young person's gender, race, favorite sport/activity, provider's gender, provider's clinic contact details, and hospital in emergency situations. The PAAP contains minimal text, instead illustrating each participant's asthma regimen using pictures, such as color-coded daily controller and rescue inhalers. Each participant will receive multiple copies of their PAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the PAAP. Pictorial Asthma Action Plan: Participants will receive a PAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their PAAP. | Young people in the Written Asthma Action Plan (WAAP) arm will receive a WAAP generated by their asthma provider using using the National Heart, Lung, and Blood Institute (NHLBI) template. The WAAP will be personalized according to the young person's treatment plan. Each participant will receive multiple copies of their WAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the WAAP. Written Asthma Action Plan: Participants will receive a WAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their WAAP. |
| Measure Participants | 22 | 23 |
| 3 Month Assessment |
2.60
(1.07)
|
2.39
(0.62)
|
| 6 Month Assessment |
2.68
(0.98)
|
2.66
(0.71)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pictorial Asthma Action Plan, Written Asthma Action Plan |
|---|---|---|
| Comments | The reference for group for this analysis is the Pictorial Asthma Action Plan group. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.18 |
| Comments | The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction. | |
| Method | multiple linear regression. | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | 0.08 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pictorial Asthma Action Plan, Written Asthma Action Plan |
|---|---|---|
| Comments | The reference for group for this analysis is the Pictorial Asthma Action Plan group. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.71 |
| Comments | The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction. | |
| Method | multiple linear regression. | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | -0.09 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pictorial Asthma Action Plan, Written Asthma Action Plan |
|---|---|---|
| Comments | The reference for group for this analysis is the Pictorial Asthma Action Plan group. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.96 |
| Comments | The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of time and group. | |
| Method | multiple linear regression. | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | 0.007 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Lung Function- FEF 25-75 |
|---|---|
| Description | This data is gathered from a spirometry test. FEF 25-75 is the air flow between 25% and 75% of forced vital capacity. |
| Time Frame | Measured at three time points over 6 months; baseline, 3- and 6-month follow-up. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., equipment difficulties). |
| Arm/Group Title | Pictorial Asthma Action Plan | Written Asthma Action Plan |
|---|---|---|
| Arm/Group Description | Young people in the Pictorial Asthma Action Plan (PAAP) arm will receive a PAAP generated by their asthma provider using a software program developed for the study. The PAAP will be personalized according to the young person's gender, race, favorite sport/activity, provider's gender, provider's clinic contact details, and hospital in emergency situations. The PAAP contains minimal text, instead illustrating each participant's asthma regimen using pictures, such as color-coded daily controller and rescue inhalers. Each participant will receive multiple copies of their PAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the PAAP. Pictorial Asthma Action Plan: Participants will receive a PAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their PAAP. | Young people in the Written Asthma Action Plan (WAAP) arm will receive a WAAP generated by their asthma provider using using the National Heart, Lung, and Blood Institute (NHLBI) template. The WAAP will be personalized according to the young person's treatment plan. Each participant will receive multiple copies of their WAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the WAAP. Written Asthma Action Plan: Participants will receive a WAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their WAAP. |
| Measure Participants | 22 | 23 |
| 3 month |
2.88
(1.14)
|
2.58
(0.68)
|
| 6 month |
2.76
(1.45)
|
2.61
(0.60)
|
| Title | Satisfaction With Asthma Action Plan-Caregiver |
|---|---|
| Description | Satisfaction questions were developed for this project and a final questionnaire developed. The Satisfaction questionnaire was completed by both parents and children at post-test (1 month, and 3 or 6 months). The scale included 11 questions, 5 reverse coded, on a 4 point Likert-type response scale. A mean item score was generated; higher scores indicate higher levels of satisfaction. Possible range of mean score was 0-4. |
| Time Frame | Measured at two time points over 6 months; 1- and 6-month follow-up. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pre-post analysis included combining 3 month and 6 month time points for outcome measures where the final time point was 3 instead of 6 months (N=6). The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., attrition, incomplete measures). |
| Arm/Group Title | Pictorial Asthma Action Plan | Written Asthma Action Plan |
|---|---|---|
| Arm/Group Description | Young people in the Pictorial Asthma Action Plan (PAAP) arm will receive a PAAP generated by their asthma provider using a software program developed for the study. The PAAP will be personalized according to the young person's gender, race, favorite sport/activity, provider's gender, provider's clinic contact details, and hospital in emergency situations. The PAAP contains minimal text, instead illustrating each participant's asthma regimen using pictures, such as color-coded daily controller and rescue inhalers. Each participant will receive multiple copies of their PAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the PAAP. Pictorial Asthma Action Plan: Participants will receive a PAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their PAAP. | Young people in the Written Asthma Action Plan (WAAP) arm will receive a WAAP generated by their asthma provider using using the National Heart, Lung, and Blood Institute (NHLBI) template. The WAAP will be personalized according to the young person's treatment plan. Each participant will receive multiple copies of their WAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the WAAP. Written Asthma Action Plan: Participants will receive a WAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their WAAP. |
| Measure Participants | 22 | 22 |
| 1 Month Assessment |
3.64
(0.37)
|
3.67
(0.30)
|
| Final (combined 3 month/6 month) |
3.60
(0.35)
|
3.68
(0.30)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pictorial Asthma Action Plan, Written Asthma Action Plan |
|---|---|---|
| Comments | The reference for group for this analysis is the Pictorial Asthma Action Plan group. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.74 |
| Comments | The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction. | |
| Method | multiple linear regression. | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | -0.02 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pictorial Asthma Action Plan, Written Asthma Action Plan |
|---|---|---|
| Comments | The reference for group for this analysis is the Pictorial Asthma Action Plan group. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.83 |
| Comments | The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction | |
| Method | multiple linear regression. | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | 0.02 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pictorial Asthma Action Plan, Written Asthma Action Plan |
|---|---|---|
| Comments | The reference for group for this analysis is the Pictorial Asthma Action Plan group. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.03 |
| Comments | The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of time and group. | |
| Method | multiple linear regression. | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | -0.21 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Satisfaction With Asthma Action Plan-Patient |
|---|---|
| Description | Satisfaction questions were developed for this project and a final questionnaire developed. The Satisfaction questionnaire was completed by both parents and children at post-test (1 month, and 3 or 6 months). The scale included 11 questions, 5 reverse coded, on a 4 point Likert-type response scale. Items were averaged together for a mean score; higher scores indicate higher levels of satisfaction. Possible range of mean score was 0-4. |
| Time Frame | Measured at two time points over 6 months; 1- and 6-month follow-up. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pre-post analysis included combining 3 month and 6 month time points for outcome measures where the final time point was 3 instead of 6 months (N=6). The number of cases analyzed differed from the overall number analyzed due to missing data (e.g., attrition, incomplete measures). |
| Arm/Group Title | Pictorial Asthma Action Plan | Written Asthma Action Plan |
|---|---|---|
| Arm/Group Description | Young people in the Pictorial Asthma Action Plan (PAAP) arm will receive a PAAP generated by their asthma provider using a software program developed for the study. The PAAP will be personalized according to the young person's gender, race, favorite sport/activity, provider's gender, provider's clinic contact details, and hospital in emergency situations. The PAAP contains minimal text, instead illustrating each participant's asthma regimen using pictures, such as color-coded daily controller and rescue inhalers. Each participant will receive multiple copies of their PAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the PAAP. Pictorial Asthma Action Plan: Participants will receive a PAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their PAAP. | Young people in the Written Asthma Action Plan (WAAP) arm will receive a WAAP generated by their asthma provider using using the National Heart, Lung, and Blood Institute (NHLBI) template. The WAAP will be personalized according to the young person's treatment plan. Each participant will receive multiple copies of their WAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the WAAP. Written Asthma Action Plan: Participants will receive a WAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their WAAP. |
| Measure Participants | 22 | 22 |
| 1 Month Assessment |
3.65
(0.24)
|
3.53
(0.40)
|
| Combined 3 month/6 month |
3.77
(0.20)
|
3.48
(0.34)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pictorial Asthma Action Plan, Written Asthma Action Plan |
|---|---|---|
| Comments | The reference for group for this analysis is the Pictorial Asthma Action Plan group. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.08 |
| Comments | The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction. | |
| Method | multiple linear regression. | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | 0.12 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pictorial Asthma Action Plan, Written Asthma Action Plan |
|---|---|---|
| Comments | The reference for group for this analysis is the Pictorial Asthma Action Plan group. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.25 |
| Comments | The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction. | |
| Method | multiple linear regression. | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | -0.12 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pictorial Asthma Action Plan, Written Asthma Action Plan |
|---|---|---|
| Comments | The reference for group for this analysis is the Pictorial Asthma Action Plan group. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.03 |
| Comments | The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of time and group. | |
| Method | multiple linear regression. | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | -0.21 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | Adverse event data were collected over 1 year. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The definition of adverse event and/or serious adverse event used to collect adverse event information in this study did not differ from the clinicaltrials.gov definition. | |||
| Arm/Group Title | Pictorial Asthma Action Plan | Written Asthma Action Plan | ||
| Arm/Group Description | Young people in the Pictorial Asthma Action Plan (PAAP) arm will receive a PAAP generated by their asthma provider using a software program developed for the study. The PAAP will be personalized according to the young person's gender, race, favorite sport/activity, provider's gender, provider's clinic contact details, and hospital in emergency situations. The PAAP contains minimal text, instead illustrating each participant's asthma regimen using pictures, such as color-coded daily controller and rescue inhalers. Each participant will receive multiple copies of their PAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the PAAP. Pictorial Asthma Action Plan: Participants will receive a PAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their PAAP. | Young people in the Written Asthma Action Plan (WAAP) arm will receive a WAAP generated by their asthma provider using using the National Heart, Lung, and Blood Institute (NHLBI) template. The WAAP will be personalized according to the young person's treatment plan. Each participant will receive multiple copies of their WAAP, after receiving a brief education session with their provider, outlining the treatment summarized in the WAAP. Written Asthma Action Plan: Participants will receive a WAAP plan, personalized to their asthma treatment. Each participant will take part in a brief education session during which their asthma provider will outline the treatment plan summarized in their WAAP. | ||
All Cause Mortality |
||||
| Pictorial Asthma Action Plan | Written Asthma Action Plan | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/22 (0%) | 0/23 (0%) | ||
Serious Adverse Events |
||||
| Pictorial Asthma Action Plan | Written Asthma Action Plan | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/22 (0%) | 0/23 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Pictorial Asthma Action Plan | Written Asthma Action Plan | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/22 (0%) | 0/23 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Christina Duncan |
|---|---|
| Organization | West Virginia University |
| Phone | 304-293-1289 |
| Christina.Duncan@mail.wvu.edu |
Responsible Party:
Christina Duncan,
Principal Investigator,
West Virginia University
ClinicalTrials.gov Identifier:
NCT03187119
Other Study ID Numbers:
- 1612396282
First Posted:
Jun 14, 2017
Last Update Posted:
Oct 22, 2021
Last Verified:
Oct 1, 2021