Improving Asthma Care Together (IMPACT): A Shared Management Pilot Study
Study Details
Study Description
Brief Summary
This study aims to iteratively develop, refine and test the Improving Asthma Care Together (IMPACT) Intervention for school-age children (7-11 years) with persistent asthma and their parents.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Asthma is one of the most common chronic conditions of childhood, affecting over six million US children. Asthma treatment relies on self-management including symptom monitoring and response, trigger avoidance, and timely and appropriate medication use. Unfortunately, fewer than 50% of children with asthma are adherent to asthma treatment regimens, leading to increased disease morbidity and mortality and potentially irreversible airway damage.
Children with asthma are missing a voice in their own care. The school-age years (7-11) represent a natural transition in asthma management, as children must assume some responsibility for asthma-related care while they spend increasing time away from parents at school and other extracurricular activities. Yet, existing interventions focus on parents alone and use prescriptive approaches, telling the parent what to "do" to the child to manage their asthma. As a result, current strategies are failing to provide children with asthma and their families the tools they need to manage asthma successfully within the realities of their daily lives.
Using a Human-Centered Design (HCD) framework, the investigators co-designed a tailored asthma shared management mobile health application that pairs the parent and child together as a team and facilitates the intentional transition of some asthma management to the child. The hypothesis is that by involving children in their own care, participants will improve asthma management in the present, but also establish lifelong successful self-management skills. The objective of the proposed study is to pilot test the Improving Asthma Care Together (IMPACT) mobile health application with parent-child dyads. Based on the preliminary data, the central hypothesis is that IMPACT will be effective for delivering a shared asthma management intervention for children and their parents.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IMPACT Intervention IMPACT health application and wearable device |
Behavioral: Improving Asthma Care Together (IMPACT)
IMPACT is a novel health application and wearable device
|
| No Intervention: Usual care control Usual care control. |
Outcome Measures
Primary Outcome Measures
- Asthma responsibility questionnaire change from baseline to 8 weeks [8 weeks]
10- items, 5-point scale to report asthma management task responsibility, higher scores indicate higher asthma management responsibility for child.
- Asthma responsibility questionnaire change from 8 to 16 weeks [16 weeks]
10- items, 5-point scale to report asthma management task responsibility, higher scores indicate higher asthma management responsibility for child.
- Asthma management self-efficacy change from baseline to 8 weeks [8 weeks]
13-items (parent) and 12-items (child), 5-point scale assesses asthma self-efficacy, higher scores indicate higher selfefficacy.
- Asthma management self-efficacy change from 8 weeks to 16 weeks [16 weeks]
13-items (parent) and 12-items (child), 5-point scale assesses asthma self-efficacy, higher scores indicate higher selfefficacy.
Secondary Outcome Measures
- Spirometry - FEV1 change from baseline to 8 weeks [8 weeks]
Spirometry - objective measure of expiratory lung function will be used to evaluate asthma control. Specifically, the FEV1 measure will be used and interpreted according to the national spirometry guideline cutpoints (NAEPP EPR4 report)
- Spirometry - FEV1 change from 8 weeks to 16 weeks [16 weeks]
Spirometry - objective measure of expiratory lung function will be used to evaluate asthma control. Specifically, the FEV1 measure will be used and interpreted according to the national spirometry guideline cutpoints (NAEPP EPR4 report)
- Spirometry - FEV1 [Weekly through intervention (weeks 0 through 8)]
Spirometry - objective measure of expiratory lung function will be used to evaluate asthma control. Intervention group will measure weekly via home spirometry device and IMPACT application. Specifically, the FEV1 measure will be used and interpreted according to the national spirometry guideline cutpoints (NAEPP EPR4 report)
- Spirometry - FEV1/FVC change from baseline to 8 weeks [8 weeks]
Spirometry - objective measure of expiratory lung function will be used to evaluate asthma control. Specifically, the FEV1/FVC measure will be used and interpreted according to the national spirometry guideline cutpoints (NAEPP EPR4 report)
- Spirometry - FEV1/FVC change from 8 weeks to 16 weeks [16 weeks]
Spirometry - objective measure of expiratory lung function will be used to evaluate asthma control. Specifically, the FEV1/FVC measure will be used and interpreted according to the national spirometry guideline cutpoints (NAEPP EPR4 report)
- Spirometry - FEV1/FVC [Weekly through intervention (weeks 0 through 8)]
Spirometry - objective measure of expiratory lung function will be used to evaluate asthma control. Intervention group will measure weekly via home spirometry device and IMPACT application. Specifically, the FEV1/FVC measure will be used and interpreted according to the national spirometry guideline cutpoints (NAEPP EPR4 report)
- Childhood Asthma Control Test change from baseline to 8 weeks [8 weeks]
7 total items--3 parent (5-point scale) and 4 child (3-point scale)-- assess asthma control, higher scores indicate better control
- Childhood Asthma Control Test change from 8 weeks to 16 weeks [16 weeks]
7 total items--3 parent (5-point scale) and 4 child (3-point scale)-- assess asthma control, higher scores indicate better control
- Childhood Asthma Quality of Life change from baseline to 8 weeks [8 weeks]
Self-report child-reported asthma quality of life, with higher scores indicating better quality of life. PROMIS Asthma Impact Scale - 8 items, 5-point scale
- Childhood Asthma Quality of Life change from 8 weeks to 16 weeks [16 weeks]
Self-report child-reported asthma quality of life, with higher scores indicating better quality of life. PROMIS Asthma Impact Scale - 8 items, 5-point scale
- Parent Asthma Quality of Life change from baseline to 8 weeks [8 weeks]
Self-report parent-reported asthma quality of life, with higher scores indicating better quality of life. PROMIS Asthma Impact Scale - 8 items, 5-point scale
- Parent Asthma Quality of Life change from 8 weeks to 16 weeks [16 weeks]
Self-report parent-reported asthma quality of life, with higher scores indicating better quality of life. PROMIS Asthma Impact Scale - 8 items, 5-point scale
- Acceptability of intervention measure [8 weeks]
4 items using 5-point scale; higher scores indicate higher acceptability.
- Medication adherence change from baseline to 8 weeks [8 weeks]
Medication Adherence Report Scale for Asthma, 10-items, 5-point scale assessing reported asthma controller medication adherence. Higher scores indicate better adherence.
- Medication adherence change from 8 weeks to 16 weeks [16 weeks]
Medication Adherence Report Scale for Asthma, 10-items, 5-point scale assessing reported asthma controller medication adherence. Higher scores indicate better adherence.
Eligibility Criteria
Criteria
CHILD Inclusion Criteria:
-
Clinician diagnosis of persistent asthma (prescription for daily asthma medication)
-
Speak English
PARENT Inclusion Criteria:
-
18 years or older
-
Child's primary caregiver
-
Able to understand and read English
-
Reside with the child 50% or more
-
Legal guardian who can consent for child to participate
-
Have access to a smart phone and reliable home internet access
CHILD Exclusion Criteria:
-
Parent report of developmental delay (language < 5 year level)
-
Co-morbid cancer, diabetes, ADHD
-
Current asthma exacerbation at the time of recruitment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Washington School of Nursing | Seattle | Washington | United States | 98195 |
Sponsors and Collaborators
- University of Washington
- National Institute of Nursing Research (NINR)
Investigators
- Principal Investigator: Jennifer T Sonney, PhD, University of Washington
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00010461
- KL2TR002317
- 1R21NR019328