Redesigning Ambulatory Care Delivery to Enhance Asthma Control in Children

• Sponsor: University of Utah (Other)
• Overall Status: Completed
• CT.gov ID: NCT02409277
• Collaborator: Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 926
• Location: 1
• Arms: 3
• Actual Duration (Months): 41
• Patients Per Site Per Month: 22.6

Study Details

Study Description

Brief Summary

The investigators have developed a tool to facilitate asthma self-management in children, the electronic-AsthmaTracker (e-AT). The e-AT changes ambulatory asthma care delivery to a new model that is continuous and proactive, focusing on prevention and control, rather than reactive and focusing on management of asthma attacks. The e-AT 1) engages parents in weekly monitoring of their child's chronic asthma symptoms, 2) guides parents to recognize warning signs of asthma attacks in order to prompt appropriate interventions and timely visits to Primary Care Providers, and 3) provides Primary Care Providers with real-time, objective patient data to assess the effectiveness of asthma therapy and prompt adjustments. In a preliminary study of the paper-based version of the AT, frequent users had significantly fewer emergency department (ED) and hospital visits. Parent comments during the e-AT pilot testing revealed that the tool was useful in helping them manage their child's asthma and were interested in assessing the tool's effectiveness and in identifying and addressing barriers to their sustained use of the e-AT.

Improving asthma control in children will be facilitated by broad e-AT dissemination, and by identifying and addressing critical factors that contribute to parent sustained participation in self-management. The investigators propose to assess the effectiveness of the new ambulatory care model supported by the e-AT and conduct an e-AT process evaluation, assessing barriers and facilitators of sustained parent use. The investigators will engage parents throughout this study to identify and address themes that matter to them. The target population is children with persistent asthma, ages 2-17 years. The investigators have engaged 10 parents since conception of this project, from the planning to design and validation of the paper-AT, and the design and pilot testing of the e-AT. Input from parents was received through 3 iterative focus groups (one for the paper-AT and 2 for the e-AT) and facilitated discussions to inform the development of this proposal including research objectives and outcome measures. In addition, the investigators have recruited other key stakeholders for whom the results of the research will be relevant.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Other: Experimental: Standard vs Intensive e-AT Intervention	N/A

Detailed Description

Through the following specific aims, the investigators will:

Aim 1: Assess the effectiveness of the new ambulatory care model, by comparing outcomes at the 1.a. child (child's quality of life (QOL), asthma control, missed school days), 1.b.parent (satisfaction, parent missed work days) and 1.c. clinic (ED/hospital visits) levels, between clinics randomly assigned to either the standard e-AT intervention vs. intensive e-AT intervention. 1.d. Use non randomized comparisons to determine the effectiveness of the e-AT relative to a control group (usual care) in which the e-AT was not used

Aim 2: Assess the association of QOL, asthma control, and ED/hospital admissions with the prior frequency of e-AT use and assess if the association differs between parent subgroups (high vs. low literacy, Medicaid vs. private insurance, and frequent vs. less frequent e-AT users).

Aim 3: Determine the association of demographic, socio-economic, behavioral, and technology factors with sustained parent participation in asthma self-management.

The outcome measures are:

Primary Outcome:

1. Child quality of life (QOL)

Secondary Outcomes:

1. Child asthma control

2. Child interrupted/missed school days

3. Child use of oral steroids (surrogate measure of an asthma exacerbation)

4. Parent satisfaction with care

5. Parent interruption/missed work days

6. Clinics: ED/Hospital admissions

Study Design

• Study Type: Interventional
• Actual Enrollment: 926 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Masking Description: We initially enrolled 327 randomized (at the clinic level) participants who received the e-AT interventions overall, including 267 participants receiving the standard intervention and 60 receiving the intensive intervention. We also included another set of 599 non-randomized matched controls of patients with persistent asthma retrieved electronically from non-participating clinics. This is why we stated that 926 subjects (327+599) overall were included.
• Primary Purpose: Prevention
• Official Title: Redesigning Ambulatory Care Delivery to Enhance Asthma Control in Children
• Actual Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Dec 31, 2016
• Actual Study Completion Date: Dec 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Standard e-AT Intervention Patients in Standard e-AT or standard intervention group will receive a daily (if a participant forgets to complete his/her weekly assessment) email and text reminders with a link to the e-AT website to help patient/parent participants to comply with their weekly assessment of patient's level of asthma control. Note: patient/parent participants are required to complete their asthma control assessment 1x/week. The e-AT is now set up to send a weekly reminder to participants with a link to the website. If a participant does not complete an assessment within a week of the last assessment, the reminder will be sent daily until the patient/parent complies and the system resets to weekly.	Other: Experimental: Standard vs Intensive e-AT Intervention; Patients will be self-monitoring their symptoms weekly using the e-AT, either the Standard or Intensive versions of the e-AT, completing the Asthma Control Test. As patients complete their assessments each week, the clinics will be able to see how each patient is doing, and follow-up when a patient is showing high symptoms for that week, potentially avoiding Emergency Room visit, and/or hospitalization.
Experimental: Intensive e-AT Intervention Participants in the intensive e-AT or adherence support intervention will receive everything as those in Standard Intervention. In addition, they will see a progress bar display, which adds 25 points each time they complete an assessment. When this bar reaches 100 points, a pop-up message with fireworks will appear to congratulate them about the milestone. The progress bar resets to zero after it reaches 100 points. Participants will also see a leader board allowing them to compare themselves with the 5 best users to increase compliance.	Other: Experimental: Standard vs Intensive e-AT Intervention; Patients will be self-monitoring their symptoms weekly using the e-AT, either the Standard or Intensive versions of the e-AT, completing the Asthma Control Test. As patients complete their assessments each week, the clinics will be able to see how each patient is doing, and follow-up when a patient is showing high symptoms for that week, potentially avoiding Emergency Room visit, and/or hospitalization.
No Intervention: Usual Care (Non-Randomized Cohort) Both arms (Intensive and standard e-AT interventions) will be compared to each other as well as to a non-randomized cohort who did not receive the e-AT interventions. These non-randomized cohort will be matched 2:1 to each randomized individuals.

Outcome Measures

Primary Outcome Measures

1. Patient Quality of Life (QOL), Compared Mean QOL Change From Baseline at Each Follow-up Assessment Between the Clinics Assigned to the Intensive and Standard e-AT Interventions [Quality of Life assessed at baseline, then compared to 3 months, 6 months, and 12 months after intervention.]

   Patient QOL and missed school days was collected longitudinally through surveys of the study population defined above. The QOL questionnaire included the Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF) and was used at baseline (at first assessment), 3, 6, and 12 months in the study. Items within QOL scales are summed and linearly transformed from 0 to 100, with higher scores indicating better functioning.

2. Patient Quality of Life (QOL), Overall Longitudinal Change (From Baseline) Within All Subjects (Who Received the e-AT Intervention) [Average Baseline QOL was compared to QOL scores at 3, 6 and 12 month follow-up QOL]

   Patient QOL and missed school days was collected longitudinally through surveys of the study population defined above. The QOL questionnaire included the Integrated Therapeutics Group Child Asthma Short Form - ITG-CASF and was used at baseline (at first assessment), 3, 6, and 12 months in the study. Items within scales are summed and linearly transformed from 0 to 100, with higher scores indicating better functioning.

Secondary Outcome Measures

1. Parent Satisfaction With Care, Standard vs Intensive [Changes in satisfaction was compared between 12 month follow-up and baseline satisfaction across Standard and Intensive interventions]

   Parent satisfaction data was collected at baseline and at 12 months in the study. The scale ranges from 1-5, with 1 being "Very Dissatisfied" and 5 "Very Satisfied".

2. Child Interrupted/Missed School Days, Standard vs Intensive [Interrupted/missed school days were collected at baseline, 3, 6, and 12 month follow-ups]

   Number of child interrupted/missed school days were collected longitudinally at the same time as collecting the QOL scores: baseline, 3, 6, and 12 months in the study. Number of child interrupted/missed school days during the 3 months prior to baseline, 3, 6, and 12 months follow-up surveys were counted.

3. Parent Interrupted/Missed Work Days, Standard vs Intensive [Interrupted/missed work days were measured baseline 3, 6, and 12 months]

   Number of parent interrupted/missed work days were collected longitudinally at the same time as collecting the QOL scores: baseline, 3, 6, and 12 months in the study. Number of parent interrupted/missed work days during the 3 months prior to baseline, 3, 6, and 12 months follow-up surveys were counted.

4. Asthma Control Change, Standard vs Intensive [Average baseline ACT scores compared to average ACT scores at quarter 1, 2, 3 and 4, and between Standard vs. Intensive]

   Asthma control information was collected weekly through the e-AT for 1 year. Asthma control was measured using the Asthma Control Test (ACT), which had a score ranging from 5 to 25, with 5 being poor control and 25 being optimal control. The analysis compared the mean change in scores from baseline to quarters 1, 2, 3, and 4.

5. Emergency Department (ED)/Hospitalization, Standard vs Intensive [Change in 1 year ED/hospital admission between 12-month prior and 12 month post e-AT use]

   ED and hospital admissions were evaluated using data collected through Intermountain Healthcare claims data and ED visits and hospital encounters. We evaluated number ED and hospital admissions 12 months prior to intervention and 12 months post intervention

6. Parent Satisfaction With Care, Overall (Change Overtime From Baseline to 12 Months) [Satisfaction at 1 year following e-AT use was compared to baseline satisfaction scores]

   Parent satisfaction data was collected using a modified version of patient satisfaction survey developed and validated by Varni et al. at baseline and at 12 months in the study. The scale ranged from 1-5, with 1=Very Dissatisfied and 5=Very Satisfied.

7. Child Asthma Control Overall (Comparing Change of Asthma Control From Baseline to Quarter 1, Quarter 2, Quarter 3 and Quarter 4) [baseline ACT scores were compared to quarters 1, 2, 3, 4.]

   Asthma control information was collected through the e-AT, comparing change of asthma control from baseline to quarter 1, quarter 2, quarter 3 and quarter 4. Asthma control was measured using the Asthma Control Test (ACT), which scale ranged from 5-25, with 5=poorly controlled and 25=well controlled. Each patient submitted an ACT score weekly for 12 months.

8. Child Interrupted/Missed School Days, Overall (Longitudinal Changes Overtime) [1 year]

   Number of child interrupted/missed school days were collected longitudinally (information includes mean at baseline, 3, 6, and 12 months in the study).

9. Parent Interrupted/Missed Work Days, Overall (Longitudinal Change Overtime) [1 year]

   Number of parent interrupted/missed work days were collected longitudinally at the same time as collecting the QOL scores: Information includes mean at baseline, 3, 6, and 12 months in the study.

10. ED/Hospital Admissions, e-AT Overall (Pre vs. Post e-AT Use Within Subjects That Received the e-AT Intervention) [1 year]

    ED/hospital re-admission data were compared between prior and post 12 month period (for both intensive and standard interventions overall) when e-AT was administered.

11. Use of Oral Steroid, Overall [1 year]

    Use of oral steroid was evaluated using data collected through Intermountain Healthcare claims data and oral steroids prescribed. Comparison was made between prior and post e-AT (both interventions) overall.

12. ED/Hospital Admission, Early vs. Late Patients [1 year following e-AT use for early and late starting patients]

    ED and hospital admission was evaluated using data collected through Intermountain Healthcare claims data and ED visits and hospital encounters. Analyses (at the patient level) comparing the rates of ED/hospital admissions between a 1 year period following initiation of the e-AT for those in both standard and intensive e-AT groups who were enrolled early during the study period (patients with enrollment dates between January 2014 and December 2014) to rates of ED/hospital admissions for patients who started the e-AT later (patients with enrollment dates between January 2015 and December 2015), during a 1-year period prior to the late patient starting the e-AT.

13. Oral Steroid Use, Early vs. Late Patients [1 year]

    Oral steroid use data was collected through Intermountain Healthcare claims data and clinics prescribing oral steroid. Oral steroid use was evaluated using data collected through Intermountain Healthcare claims data and oral steroids prescribed. Analyses (at the patient level) comparing the rates oral steroid use between a 1 year period following initiation of the e-AT for those in both standard and intensive e-AT groups who were enrolled early during the study period (patients with enrollment dates between January 2014 and December 2014) to rates of oral steroid use for patients who started the e-AT later (patients with enrollment dates between January 2015 and December 2015), during a 1-year period prior to the late patient starting the e-AT.

14. ED/Hospital Admission, Early vs Late Starting Clinics (During the 3 Months When Late Starting Clinics Have Not Used the e-AT) [3-month period prior to the late clinics starting the e-AT]

    ED and hospital admission evaluated using data collected through Intermountain Healthcare claims data and ED visits and hospital encounters. Statistical analysis was not conducted since the numbers of ED/Hospital admissions was very small (2 and 0) in both group (during the 3 months study window). Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) participants.

15. Oral Steroid Use, Early vs Late Starting Clinics (During the 3 Months When Late Starting Clinics Have Not Started the e-AT) [3 month period prior to the late clinics starting the e-AT]

    Use of oral steroid was evaluated using data collected through Intermountain Healthcare claims data and oral steroids prescribed. Statistical analysis was not conducted since the numbers of ED/Hospital admissions was very small (2 and 0) in both group (during the 3 months study window). Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) participants

16. ED/Hospital Admissions, e-AT vs Usual Care [1 year]

    Non randomized comparison of ED and hospital admissions between e-AT interventions (both intensive and standard) compared usual care (matched control patients drawn from non-participating clinics) in the prior vs. post e-AT intervention time periods.

17. Oral Steroid Use, e-AT vs Usual Care [1 year]

    Non randomized comparison of use of oral steroid between e-AT interventions (both intensive and standard) compared usual care (matched control patients drawn from non-participating clinics) in the prior vs. post e-AT intervention time periods.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Facility Eligibility

Clinics are eligible for participation if they meet the following criteria:

1. Primary care clinics with the clinical leadership to adopt use of e-AT for asthma management.

2. Have patients between 2 and 17 years of age with persistent asthma.

3. Ability of the facility to accommodate patient enrollment and training about use of e-AT.

Patient Inclusion Criteria

1. Children ages 2 through 17 years and their parents (main parents or caregiver)

2. English speakers

3. Children who received or are receiving asthma treatment (at participating clinics).

4. Parents have Internet access

5. Children with persistent asthma.

Patient Exclusion Criteria:

As this is a pragmatic trial assessing evidence of the e-AT in a real clinical environment, no patients will be excluded as long as they meet inclusion criteria. However, during the time of analysis, we will conduct a sub-analysis, comparing the effectiveness of the new care model among patients with or without co-morbid conditions that may affect measured asthma outcomes. These include patients with a history or increased risk of pulmonary disease (cystic fibrosis, bronco-pulmonary dysplasia, aspiration pneumonia, severe Cerebral Palsy (CP) with aspiration risk, technology dependency (gastrostomy tube, tracheostomy), history of congenital heart disease requiring surgical correction or with complicating congestive heart failure requiring medical management, immunodeficiency (including patients on immunosuppressants), and malignancies.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Utah	Salt Lake City	Utah	United States	84113

Sponsors and Collaborators

• University of Utah
• Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Flory Nkoy, MD, MS, MPH, University of Utah

Study Documents (Full-Text)

None provided.

More Information

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• Responsible Party: Flory Nkoy, Associate Professor, University of Utah
• ClinicalTrials.gov Identifier: NCT02409277
• Other Study ID Numbers: 51002874
• First Posted: Apr 6, 2015
• Last Update Posted: Feb 5, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Flory Nkoy, Associate Professor, University of Utah: Self-Management; Asthma
• Additional relevant MeSH terms: Asthma

Study Results

Participant Flow

Arm/Group Title	Standard e-Asthma Tracker (e-AT) Intervention	Intensive e-Asthma Tracker (e-AT) Intervention	Usual Care (Non-Randomized Cohort)
Arm/Group Description	Patients in Standard e-AT intervention group will be using the standard version of e-AT	Participants in the intensive e-AT intervention group will be using an enhanced version of the standard e-AT, i.e. addition of progress bar indicating the patients' status of completing 4 scores in a month, fireworks when they reach 100% on the progress bar, a leaderboard to compare their own status among other e-AT users.	Both arms (Intensive and standard e-AT interventions) will be compared to each other as well as to a non-randomized cohort who did not receive the e-AT interventions. These non-randomized cohort will be matched 2:1 to each randomized individuals.
Period Title: Overall Study
STARTED	267	60	599
3 Months Follow-up	178	40	599
6 Months Follow-up	182	42	599
12 Months Follow-up	167	43	599
COMPLETED	167	43	599
NOT COMPLETED	100	17	0

Baseline Characteristics

Arm/Group Title	Standard e-AT Intervention	Intensive e-AT Intervention	Usual Care (Non-Randomized Cohort)	Total
Arm/Group Description	Patients in Standard e-AT intervention group will be using the standard version of e-AT.	Participants in the intensive e-AT intervention group will be using an enhanced version of the standard e-AT, i.e. addition of progress bar indicating the patients' status of completing 4 scores in a month, fireworks when they reach 100% on the progress bar, a leaderboard to compare their own status among other e-AT users.	Both arms (Intensive and standard e-AT interventions) will be compared to each other as well as to a non-randomized cohort who did not receive the e-AT interventions. These non-randomized cohort will be matched 2:1 to each randomized individuals.	Total of all reporting groups
Overall Participants	267	60	599	926
Age (Count of Participants)
<=18 years	267 100%	60 100%	599 100%	926 100%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	8.12 (3.99)	7.18 (8.12)	8.04 (3.86)	7.97 (3.89)
Sex: Female, Male (Count of Participants)
Female	110 41.2%	23 38.3%	228 38.1%	361 39%
Male	157 58.8%	37 61.7%	371 61.9%	565 61%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	40 15%	4 6.7%	72 12%	116 12.5%
Not Hispanic or Latino	216 80.9%	53 88.3%	520 86.8%	789 85.2%
Unknown or Not Reported	11 4.1%	3 5%	7 1.2%	21 2.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	5 1.9%	1 1.7%	5 0.8%	11 1.2%
Asian	3 1.1%	1 1.7%	11 1.8%	15 1.6%
Native Hawaiian or Other Pacific Islander	7 2.6%	0 0%	9 1.5%	16 1.7%
Black or African American	9 3.4%	1 1.7%	23 3.8%	33 3.6%
White	223 83.5%	51 85%	537 89.6%	811 87.6%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	20 7.5%	6 10%	14 2.3%	40 4.3%
Region of Enrollment (Count of Participants)
United States	267 100%	60 100%	599 100%	926 100%

Outcome Measures

1. Primary Outcome

Title	Patient Quality of Life (QOL), Compared Mean QOL Change From Baseline at Each Follow-up Assessment Between the Clinics Assigned to the Intensive and Standard e-AT Interventions
Description	Patient QOL and missed school days was collected longitudinally through surveys of the study population defined above. The QOL questionnaire included the Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF) and was used at baseline (at first assessment), 3, 6, and 12 months in the study. Items within QOL scales are summed and linearly transformed from 0 to 100, with higher scores indicating better functioning.
Time Frame	Quality of Life assessed at baseline, then compared to 3 months, 6 months, and 12 months after intervention.

Outcome Measure Data

Analysis Population Description

We enrolled 327, 2 clinics with only 1 patient enrolled were excluded, leaving 325 patients. Of 325, 7 did not provide baselines and were excluded, leaving 318 (261 standard vs. 57 intensive) participants. Row numbers differ due to different number of participants completing 3, 6, and 12 months follow-ups, due to withdrawal and loss to follow-up.

Arm/Group Title	Standard e-AT Intervention	Intensive e-AT Intervention
Arm/Group Description	Patients in Standard e-AT intervention group using the standard version of e-AT.	Participants in the intensive e-AT intervention group using an enhanced version of the standard e-AT, i.e. addition of progress bar indicating the patients' status of completing 4 scores in a month, fireworks when they reach 100% on the progress bar, a leaderboard to compare their own status among other e-AT users.
Measure Participants	261	57
3 Months Follow-up vs Baseline	8.55 (0.97)	7.64 (2.53)
6 Months Follow-up compared vs Baseline	8.37 (0.86)	5.78 (1.94)
12 Months Follow-up vs Baseline	9.39 (0.76)	9.29 (1.80)

2. Primary Outcome

Title	Patient Quality of Life (QOL), Overall Longitudinal Change (From Baseline) Within All Subjects (Who Received the e-AT Intervention)
Description	Patient QOL and missed school days was collected longitudinally through surveys of the study population defined above. The QOL questionnaire included the Integrated Therapeutics Group Child Asthma Short Form - ITG-CASF and was used at baseline (at first assessment), 3, 6, and 12 months in the study. Items within scales are summed and linearly transformed from 0 to 100, with higher scores indicating better functioning.
Time Frame	Average Baseline QOL was compared to QOL scores at 3, 6 and 12 month follow-up QOL

Outcome Measure Data

Analysis Population Description

The numbers analyzed in the rows are different due to different number of participants completing the surveys throughout 3, 6, and 12 months. This was due to withdrawal from the study or loss to follow-up.

Arm/Group Title	All e-AT Users
Arm/Group Description	This group consists of all e-AT users, both standard and intensive interventions.
Measure Participants	318
Baseline	79.07 (14.20)
3 Months	90.98 (9.54)
6 Months	90.04 (11.12)
12 Months	90.64 (10.34)

3. Secondary Outcome

Title	Parent Satisfaction With Care, Standard vs Intensive
Description	Parent satisfaction data was collected at baseline and at 12 months in the study. The scale ranges from 1-5, with 1 being "Very Dissatisfied" and 5 "Very Satisfied".
Time Frame	Changes in satisfaction was compared between 12 month follow-up and baseline satisfaction across Standard and Intensive interventions

Outcome Measure Data

Analysis Population Description

We had 261 in Standard e-AT and 57 in Intensive e-AT who completed baseline survey, and 166 in Standard e-AT and 42 in Intensive e-AT completed the 12 Months Follow-up Survey. This is due to participant withdrawal and loss to follow-up.

Arm/Group Title	Standard e-AT Intervention	Intensive e-AT Intervention
Arm/Group Description	Patients in Standard e-AT intervention group will be using the standard version of e-AT.	Participants in the intensive e-AT intervention group will be using an enhanced version of the standard e-AT, i.e. addition of progress bar indicating the patients' status of completing 4 scores in a month, fireworks when they reach 100% on the progress bar, a leaderboard to compare their own status among other e-AT users.
Measure Participants	261	57
Baseline	4.63	4.63
12 months Follow-up	4.38	4.54

4. Secondary Outcome

Title	Child Interrupted/Missed School Days, Standard vs Intensive
Description	Number of child interrupted/missed school days were collected longitudinally at the same time as collecting the QOL scores: baseline, 3, 6, and 12 months in the study. Number of child interrupted/missed school days during the 3 months prior to baseline, 3, 6, and 12 months follow-up surveys were counted.
Time Frame	Interrupted/missed school days were collected at baseline, 3, 6, and 12 month follow-ups

Outcome Measure Data

Analysis Population Description

We had 261 Standard and 57 Intensive e-AT who completed baseline survey. Numbers in the row differ due to different number of participants who completed 3, 6, and 12 months surveys, due to participant compliance, withdrawal or loss-to-follow-up. 3, 6, and 12 month measurements were compared to Baseline, between Standard vs Intensive interventions

Arm/Group Title	Standard e-AT Intervention	Intensive e-AT Intervention
Arm/Group Description	Patients in Standard e-AT intervention group will be using the standard version of e-AT.	Participants in the intensive e-AT intervention group will be using an enhanced version of the standard e-AT, i.e. addition of progress bar indicating the patients' status of completing 4 scores in a month, fireworks when they reach 100% on the progress bar, a leaderboard to compare their own status among other e-AT users.
Measure Participants	261	57
Baseline	435	129
3 Months Follow-up	114	60
6 Months Follow-up	87	30
12 Months Follow-up	129	37

5. Secondary Outcome

Title	Parent Interrupted/Missed Work Days, Standard vs Intensive
Description	Number of parent interrupted/missed work days were collected longitudinally at the same time as collecting the QOL scores: baseline, 3, 6, and 12 months in the study. Number of parent interrupted/missed work days during the 3 months prior to baseline, 3, 6, and 12 months follow-up surveys were counted.
Time Frame	Interrupted/missed work days were measured baseline 3, 6, and 12 months

Outcome Measure Data

Analysis Population Description

We had 261 Standard and 57 Intensive e-AT who completed baseline survey. Numbers in the row differ due to different number of participants who completed 3, 6, and 12 months surveys, due to participant compliance, withdrawal or loss-to-follow-up. 3, 6, and 12 month measurements were compared to Baseline, between Standard vs Intensive interventions

Arm/Group Title	Standard e-AT Intervention	Intensive e-AT Intervention
Arm/Group Description	Patients in Standard e-AT intervention group will be using the standard version of e-AT.	Participants in the intensive e-AT intervention group will be using an enhanced version of the standard e-AT, i.e. addition of progress bar indicating the patients' status of completing 4 scores in a month, fireworks when they reach 100% on the progress bar, a leaderboard to compare their own status among other e-AT users.
Measure Participants	261	57
Baseline	176	56
3 Months Follow-up	44	14
6 Months Follow-up	42	15
12 Months Follow-up	23	18

6. Secondary Outcome

Title	Asthma Control Change, Standard vs Intensive
Description	Asthma control information was collected weekly through the e-AT for 1 year. Asthma control was measured using the Asthma Control Test (ACT), which had a score ranging from 5 to 25, with 5 being poor control and 25 being optimal control. The analysis compared the mean change in scores from baseline to quarters 1, 2, 3, and 4.
Time Frame	Average baseline ACT scores compared to average ACT scores at quarter 1, 2, 3 and 4, and between Standard vs. Intensive

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard e-AT Intervention	Intensive e-AT Intervention
Arm/Group Description	Patients in Standard e-AT intervention group using the standard version of e-AT.	Participants in the intensive e-AT intervention group using an enhanced version of the standard e-AT, i.e. addition of progress bar indicating the patients' status of completing 4 scores in a month, fireworks when they reach 100% on the progress bar, a leaderboard to compare their own status among other e-AT users.
Measure Participants	261	57
Qtr 1 vs baseline	2.55 (0.12)	1.78 (0.35)
Qtr 2 vs baseline	3.09 (0.10)	2.18 (0.30)
Qtr 3 vs baseline	3.26 (0.09)	2.18 (0.23)
Qtr 4 vs baseline	3.33 (0.10)	3.30 (0.22)

7. Secondary Outcome

Title	Emergency Department (ED)/Hospitalization, Standard vs Intensive
Description	ED and hospital admissions were evaluated using data collected through Intermountain Healthcare claims data and ED visits and hospital encounters. We evaluated number ED and hospital admissions 12 months prior to intervention and 12 months post intervention
Time Frame	Change in 1 year ED/hospital admission between 12-month prior and 12 month post e-AT use

Outcome Measure Data

Analysis Population Description

Number of pre- and post e-AT ED and hospital admissions were compared between standard and intensive groups.

Arm/Group Title	Standard e-AT Intervention	Intensive e-AT Intervention
Arm/Group Description	Patients in Standard e-AT intervention group will be using the standard version of e-AT.	Participants in the intensive e-AT intervention group will be using an enhanced version of the standard e-AT, i.e. addition of progress bar indicating the patients' status of completing 4 scores in a month, fireworks when they reach 100% on the progress bar, a leaderboard to compare their own status among other e-AT users.
Measure Participants	261	57
Prior	53	18
Post	21	8

8. Secondary Outcome

Title	Parent Satisfaction With Care, Overall (Change Overtime From Baseline to 12 Months)
Description	Parent satisfaction data was collected using a modified version of patient satisfaction survey developed and validated by Varni et al. at baseline and at 12 months in the study. The scale ranged from 1-5, with 1=Very Dissatisfied and 5=Very Satisfied.
Time Frame	Satisfaction at 1 year following e-AT use was compared to baseline satisfaction scores

Outcome Measure Data

Analysis Population Description

We had 318 participants who have completed the baseline satisfaction survey, and 208 who completed 12 months follow-up survey, due to participants withdrawing from the study and loss to follow-up.

Arm/Group Title	All e-AT Users
Arm/Group Description	This group consists of all e-AT users, both standard and intensive interventions.
Measure Participants	318
Baseline	4.66 (0.51)
12 months Follow-up	4.46 (0.53)

9. Secondary Outcome

Title	Child Asthma Control Overall (Comparing Change of Asthma Control From Baseline to Quarter 1, Quarter 2, Quarter 3 and Quarter 4)
Description	Asthma control information was collected through the e-AT, comparing change of asthma control from baseline to quarter 1, quarter 2, quarter 3 and quarter 4. Asthma control was measured using the Asthma Control Test (ACT), which scale ranged from 5-25, with 5=poorly controlled and 25=well controlled. Each patient submitted an ACT score weekly for 12 months.
Time Frame	baseline ACT scores were compared to quarters 1, 2, 3, 4.

Outcome Measure Data

Analysis Population Description

Patients were told to submit an ACT score once a week for 12 months. 311 patients completed at least one ACT score for a total number of 11418 ACT scores submitted using e-AT by all e-AT users (during study period).

Arm/Group Title	All e-AT Users
Arm/Group Description	This group consists of all e-AT users, both standard and intensive interventions. We will be looking at ACT scores submitted by the e-AT users to report asthma control over 12 months.
Measure Participants	311
Measure ACT scores	11418
Baseline	18.85 (5.49)
Quarter 1	22.28 (3.25)
Quarter 2	22.82 (2.95)
Quarter 3	22.81 (2.98)
Quarter 4	22.97 (2.76)

10. Secondary Outcome

Title	Child Interrupted/Missed School Days, Overall (Longitudinal Changes Overtime)
Description	Number of child interrupted/missed school days were collected longitudinally (information includes mean at baseline, 3, 6, and 12 months in the study).
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The numbers analyzed in the rows are different due to different number of participants completing the surveys throughout 3, 6, and 12 months. This was due to either compliance, withdrawal or loss to follow-up.

Arm/Group Title	All e-AT Users
Arm/Group Description	This group consists of all e-AT users, both standard and intensive interventions
Measure Participants	318
Baseline	1.91 (5.18)
3 Months Follow-up	0.80 (2.07)
6 Months Follow-up	0.52 (1.34)
12 Months Follow-up	0.79 (2.06)

11. Secondary Outcome

Title	Parent Interrupted/Missed Work Days, Overall (Longitudinal Change Overtime)
Description	Number of parent interrupted/missed work days were collected longitudinally at the same time as collecting the QOL scores: Information includes mean at baseline, 3, 6, and 12 months in the study.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The numbers analyzed in the rows are different due to different number of participants completing the surveys throughout 3, 6, and 12 months. This was due to either compliance, withdrawal or loss to follow-up.

Arm/Group Title	All e-AT Users
Arm/Group Description	This group consists of all e-AT users, both standard and intensive interventions.
Measure Participants	318
Baseline	0.72 (1.89)
3 Months Follow-up	0.27 (0.99)
6 Months Follow-Up	0.25 (1.02)
12 Months Follow-up	0.20 (0.83)

12. Secondary Outcome

Title	ED/Hospital Admissions, e-AT Overall (Pre vs. Post e-AT Use Within Subjects That Received the e-AT Intervention)
Description	ED/hospital re-admission data were compared between prior and post 12 month period (for both intensive and standard interventions overall) when e-AT was administered.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) participants

Arm/Group Title	Prior e-AT Use	Post e-AT Use
Arm/Group Description	The participants enrolled in both standard and intensive e-AT groups served as their own control. This arm includes ED/Hospital use among the participants 1 year before using the e-AT.	The participants enrolled in both standard and intensive e-AT groups served as their own control. This arm includes ED/Hospital use among the participants 1 year after starting using the e-AT.
Measure Participants	325	325
Mean (Standard Deviation) [number of ED/hospital admission]	0.22 (0.60)	0.09 (0.35)

13. Secondary Outcome

Title	Use of Oral Steroid, Overall
Description	Use of oral steroid was evaluated using data collected through Intermountain Healthcare claims data and oral steroids prescribed. Comparison was made between prior and post e-AT (both interventions) overall.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) participants

Arm/Group Title	Prior e-AT Use	Post e-AT Use
Arm/Group Description	The participants enrolled in both standard and intensive e-AT groups served as their own control. This arm includes oral steriod use among the participants 1 year before using the e-AT.	The participants enrolled in both standard and intensive e-AT groups served as their own control. This arm includes the oral steriod use among the participants 1 year after starting using the e-AT.
Measure Participants	325	325
Mean (Standard Deviation) [number of oral steroid use]	0.74 (1.15)	0.51 (0.95)

14. Secondary Outcome

Title	ED/Hospital Admission, Early vs. Late Patients
Description	ED and hospital admission was evaluated using data collected through Intermountain Healthcare claims data and ED visits and hospital encounters. Analyses (at the patient level) comparing the rates of ED/hospital admissions between a 1 year period following initiation of the e-AT for those in both standard and intensive e-AT groups who were enrolled early during the study period (patients with enrollment dates between January 2014 and December 2014) to rates of ED/hospital admissions for patients who started the e-AT later (patients with enrollment dates between January 2015 and December 2015), during a 1-year period prior to the late patient starting the e-AT.
Time Frame	1 year following e-AT use for early and late starting patients

Outcome Measure Data

Analysis Population Description

Intent-to-treat analysis was used, including all 325. Randomized comparisons compared intensive vs. standard e-AT, but not e-AT efficacy vs usual care. This nonrandomized analysis (Early vs Late Patients) assesses e-AT efficacy, comparing outcomes between "period" patients were under the e-AT vs "periods" other patients were not using the e-AT.

Arm/Group Title	Early Starting Patients	Late Starting Patients
Arm/Group Description	Patients starting with e-AT intervention early (in 2014)	Patients starting with e-AT intervention later (in 2015)
Measure Participants	234	91
Mean (Standard Deviation) [number of ED/Hospital admission]	0.10 (0.38)	0.18 (0.10)

15. Secondary Outcome

Title	Oral Steroid Use, Early vs. Late Patients
Description	Oral steroid use data was collected through Intermountain Healthcare claims data and clinics prescribing oral steroid. Oral steroid use was evaluated using data collected through Intermountain Healthcare claims data and oral steroids prescribed. Analyses (at the patient level) comparing the rates oral steroid use between a 1 year period following initiation of the e-AT for those in both standard and intensive e-AT groups who were enrolled early during the study period (patients with enrollment dates between January 2014 and December 2014) to rates of oral steroid use for patients who started the e-AT later (patients with enrollment dates between January 2015 and December 2015), during a 1-year period prior to the late patient starting the e-AT.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Intent-to-treat analysis was used, including all 325. Randomized comparisons compared intensive vs. standard e-AT, but not e-AT efficacy vs usual care. This nonrandomized analysis (Early vs Late Patients) assesses e-AT efficacy, comparing outcomes between "period" patients were under the e-AT vs "periods" other patients were not using the e-AT.

Arm/Group Title	Early Starting Patients	Late Starting Patients
Arm/Group Description	Patients starting with e-AT intervention early (in 2014)	Patients starting with e-AT intervention later (in 2015)
Measure Participants	234	91
Mean (Standard Deviation) [number of oral steroid use]	0.53 (0.99)	0.53 (0.92)

16. Secondary Outcome

Title	ED/Hospital Admission, Early vs Late Starting Clinics (During the 3 Months When Late Starting Clinics Have Not Used the e-AT)
Description	ED and hospital admission evaluated using data collected through Intermountain Healthcare claims data and ED visits and hospital encounters. Statistical analysis was not conducted since the numbers of ED/Hospital admissions was very small (2 and 0) in both group (during the 3 months study window). Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) participants.
Time Frame	3-month period prior to the late clinics starting the e-AT

Outcome Measure Data

Analysis Population Description

Intent-to-treat analysis was used, including all 325. Randomized comparisons compared intensive vs. standard e-AT, but not e-AT efficacy vs usual care. This nonrandomized analysis (Early vs Late Clinics) assesses e-AT efficacy, comparing outcomes between "period" clinics were under the e-AT vs "periods" other clinics were not using the e-AT.

Arm/Group Title	Early Starting Clinics	Late Starting Clinics
Arm/Group Description	ED/Hospital admission for patients in clinics that started with the e-AT intervention from Jan 3, 2014 to Mar 24, 2014.	ED/Hospital admission for patients in clinics that started with the e-AT intervention after March 24, 2014.
Measure Participants	206	119
Number [number of ED/Hospital admission]	2	0

17. Secondary Outcome

Title	Oral Steroid Use, Early vs Late Starting Clinics (During the 3 Months When Late Starting Clinics Have Not Started the e-AT)
Description	Use of oral steroid was evaluated using data collected through Intermountain Healthcare claims data and oral steroids prescribed. Statistical analysis was not conducted since the numbers of ED/Hospital admissions was very small (2 and 0) in both group (during the 3 months study window). Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) participants
Time Frame	3 month period prior to the late clinics starting the e-AT

Outcome Measure Data

Analysis Population Description

Intent-to-treat analysis was used, including all 325. Randomized comparisons compared intensive vs. standard e-AT, but not e-AT efficacy vs usual care. This nonrandomized analysis (Early vs Late Clinics) assesses e-AT efficacy, comparing outcomes between "period" clinics were under the e-AT vs "periods" other clinics were not using the e-AT.

Arm/Group Title	Early Patients	Late Patients
Arm/Group Description	Oral steroid use between Jan 3, 2014-March 24, 2014 for patients who were enrolled in e-AT intervention from Jan 3, 2014 to Mar 24, 2014.	Oral steroid use between Jan 3, 2014-March 24, 2014 for patients who were enrolled into e-AT after March 24, 2014.
Measure Participants	206	119
Number [number of oral steroid use]	4	0

18. Secondary Outcome

Title	ED/Hospital Admissions, e-AT vs Usual Care
Description	Non randomized comparison of ED and hospital admissions between e-AT interventions (both intensive and standard) compared usual care (matched control patients drawn from non-participating clinics) in the prior vs. post e-AT intervention time periods.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) e-AT participants and 599 matched controls retrieved electronically from non-participating clinics.

Arm/Group Title	e-AT Intervention	Usual Care (Non-randomized Cohort)
Arm/Group Description	All e-AT users who have received the e-AT intervention for 12 months, randomized to either standard or intensive group.	Those who have not received any e-AT intervention and received usual care.
Measure Participants	325	599
Prior	0.59 (1.64)	0.23 (1.01)
Post	0.24 (0.97)	0.24 (0.97)

19. Secondary Outcome

Title	Oral Steroid Use, e-AT vs Usual Care
Description	Non randomized comparison of use of oral steroid between e-AT interventions (both intensive and standard) compared usual care (matched control patients drawn from non-participating clinics) in the prior vs. post e-AT intervention time periods.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) e-AT participants and 599 matched controls retrieved electronically from non-participating clinics.

Arm/Group Title	e-AT Intervention	Usual Care (Non-randomized Cohort)
Arm/Group Description	All e-AT users who have received the e-AT intervention for 12 months, randomized to either standard or intensive group.	Matched control participants from non-participating clinics that have not received any e-AT intervention and received usual care.
Measure Participants	325	599
Prior	2.02 (3.14)	1.87 (3.12)
Post	1.41 (2.60)	1.99 (7.89)

Adverse Events

Adverse Event Reporting Description	This study is a minimal risk study, with patients logging in to a secure web-based self-management tool and answering questions about their asthma symptoms. The only intervention in the study was to have patients use this tool to manage asthma. No serious adverse risk is involved in this study.
Arm/Group Title	Standard e-AT Intervention		Intensive e-AT Intervention		Usual Care (Non-Randomized Cohort)
Arm/Group Description	Patients in Standard e-AT intervention group will be using the standard version of e-AT.		Participants in the intensive e-AT intervention group will be using an enhanced version of the standard e-AT, i.e. addition of progress bar indicating the patients' status of completing 4 scores in a month, fireworks when they reach 100% on the progress bar, a leaderboard to compare their own status among other e-AT users.		Both arms (Intensive and standard e-AT interventions) will be compared to each other as well as to a non-randomized cohort who did not receive the e-AT interventions. These non-randomized cohort will be matched 2:1 to each randomized individuals.
All Cause Mortality
	Standard e-AT Intervention		Intensive e-AT Intervention		Usual Care (Non-Randomized Cohort)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard e-AT Intervention		Intensive e-AT Intervention		Usual Care (Non-Randomized Cohort)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/267 (0%)		0/60 (0%)		0/599 (0%)
Other (Not Including Serious) Adverse Events
	Standard e-AT Intervention		Intensive e-AT Intervention		Usual Care (Non-Randomized Cohort)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/267 (0%)		0/60 (0%)		0/599 (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.