Improving Asthma Care Together (IMPACT): A Shared Management Pilot Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Improving Asthma Care Together (IMPACT): A Shared Management Pilot Study for Children With Asthma and Their Parents

Conditions
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Asthma in Children

Intervention / Treatment
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* Behavioral: Improving Asthma Care Together (IMPACT)


Participation Criteria
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Eligibility Criteria
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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 Reported Asthma Responsibility Questionnaire score < or = 2.5 at screening 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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMPACT Intervention<br>IMPACT health application and wearable device | Behavioral: Improving Asthma Care Together (IMPACT)<br>* IMPACT is a novel health application and wearable device<br>|
| No Intervention: Usual care control<br>Usual care control. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma responsibility questionnaire change from baseline to 8 weeks | 10- items, 5-point scale to report asthma management task responsibility, higher scores indicate higher asthma management responsibility for child. | 8 weeks | 
| Asthma responsibility questionnaire change from 8 to 16 weeks | 10- items, 5-point scale to report asthma management task responsibility, higher scores indicate higher asthma management responsibility for child. | 16 weeks | 
| Asthma management self-efficacy change from baseline to 8 weeks | 13-items (parent) and 12-items (child), 5-point scale assesses asthma self-efficacy, higher scores indicate higher selfefficacy. | 8 weeks | 
| Asthma management self-efficacy change from 8 weeks to 16 weeks | 13-items (parent) and 12-items (child), 5-point scale assesses asthma self-efficacy, higher scores indicate higher selfefficacy. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spirometry - FEV1 change from baseline to 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) | 8 weeks | 
| Spirometry - FEV1 change from 8 weeks to 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) | 16 weeks | 
| Spirometry - FEV1 | 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) | Weekly through intervention (weeks 0 through 8) | 
| Spirometry - FEV1/FVC change from baseline to 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) | 8 weeks | 
| Spirometry - FEV1/FVC change from 8 weeks to 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) | 16 weeks | 
| Spirometry - FEV1/FVC | 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) | Weekly through intervention (weeks 0 through 8) | 
| Childhood Asthma Control Test change from baseline to 8 weeks | 7 total items--3 parent (5-point scale) and 4 child (3-point scale)-- assess asthma control, higher scores indicate better control | 8 weeks | 
| Childhood Asthma Control Test | 7 total items--3 parent (5-point scale) and 4 child (3-point scale)-- assess asthma control, higher scores indicate better control | Weekly through intervention (week 0 through 8) | 
| Childhood Asthma Control Test change from 8 weeks to 16 weeks | 7 total items--3 parent (5-point scale) and 4 child (3-point scale)-- assess asthma control, higher scores indicate better control | 16 weeks | 
| Childhood Asthma Quality of Life change from baseline to 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 | 8 weeks | 
| Childhood Asthma Quality of Life change from 8 weeks to 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 | 16 weeks | 
| Parent Asthma Quality of Life change from baseline to 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 | 8 weeks | 
| Parent Asthma Quality of Life change from 8 weeks to 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 | 16 weeks | 
| Acceptability of intervention measure | 4 items using 5-point scale; higher scores indicate higher acceptability. | 8 weeks | 
| Medication adherence change from baseline to 8 weeks | Medication Adherence Report Scale for Asthma, 10-items, 5-point scale assessing reported asthma controller medication adherence. Higher scores indicate better adherence. | 8 weeks | 
| Medication adherence change from 8 weeks to 16 weeks | Medication Adherence Report Scale for Asthma, 10-items, 5-point scale assessing reported asthma controller medication adherence. Higher scores indicate better adherence. | 16 weeks | 
| Feasibility of intervention (intervention group only) | Feasibility of intervention 4-items, 5-point scale, with higher scores indicating higher feasibility. | 8 weeks | 
| System usability scale (intervention group only) | System usability scale - 10 items, 5-point scale to determine perceived usability of a system. Higher scores indicate higher usability. | 8 weeks | 
| Semi-structured interview (intervention group only) | 12-question semi-structured interview to determine parent and child acceptability of intervention and elicit feedback and suggested revisions. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-management, Shared management, mHealth