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

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

National Institute of Nursing Research (NINR), National Center for Advancing Translational Sciences (NCATS)

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.

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.

10- items, 5-point scale to report asthma management task responsibility, higher scores indicate higher asthma management responsibility for child.

10- items, 5-point scale to report asthma management task responsibility, higher scores indicate higher asthma management responsibility for child.

13-items (parent) and 12-items (child), 5-point scale assesses asthma self-efficacy, higher scores indicate higher selfefficacy.

13-items (parent) and 12-items (child), 5-point scale assesses asthma self-efficacy, higher scores indicate higher selfefficacy.

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 - 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 - 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 - 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 - 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 - 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)

7 total items--3 parent (5-point scale) and 4 child (3-point scale)-- assess asthma control, higher scores indicate better control

7 total items--3 parent (5-point scale) and 4 child (3-point scale)-- assess asthma control, higher scores indicate better control

7 total items--3 parent (5-point scale) and 4 child (3-point scale)-- assess asthma control, higher scores indicate better control

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

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

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

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

Medication Adherence Report Scale for Asthma, 10-items, 5-point scale assessing reported asthma controller medication adherence. Higher scores indicate better adherence.

Medication Adherence Report Scale for Asthma, 10-items, 5-point scale assessing reported asthma controller medication adherence. Higher scores indicate better adherence.

Feasibility of intervention 4-items, 5-point scale, with higher scores indicating higher feasibility.

System usability scale - 10 items, 5-point scale to determine perceived usability of a system. Higher scores indicate higher usability.

12-question semi-structured interview to determine parent and child acceptability of intervention and elicit feedback and suggested revisions.

McMaster Family Assessment Device, 60-item parent-report instrument, 4-point scale to evaluate family functioning. Higher scores indicate worsened levels of functioning.

McMaster Family Assessment Device, 60-item parent-report instrument, 4-point scale to evaluate family functioning. Higher scores indicate worsened levels of functioning.

Brief Illness Perception Questionnaire, 8-items, 10-point scale to assess individual beliefs about a health condition. Higher scores indicate more burdensome perception.

Brief Illness Perception Questionnaire, 8-items, 10-point scale to assess individual beliefs about a health condition. Higher scores indicate more burdensome perception.

Beliefs about Medicines Questionnaire, 10 items, 5-point scale to assess perceived medication necessity and concerns. Medication necessity scores range from 5 to 25. Medication concerns scores range from 5 to 25. Necessity-concern differential calculated to determine whether concerns outweigh perceived necessity. Positive (higher) scores indicate perceived necessity outweighing concerns whereas negative scores indicate concerns outweigh the necessity.

Beliefs about Medicines Questionnaire, 10 items, 5-point scale to assess perceived medication necessity and concerns. Medication necessity scores range from 5 to 25. Medication concerns scores range from 5 to 25. Necessity-concern differential calculated to determine whether concerns outweigh perceived necessity. Positive (higher) scores indicate perceived necessity outweighing concerns whereas negative scores indicate concerns outweigh the necessity.

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

Sonney J, Ward T, Thompson HJ, Kientz JA, Segrin C. Improving Asthma Care Together (IMPACT) mobile health intervention for school-age children with asthma and their parents: a pilot randomised controlled trial study protocol. BMJ Open. 2022 Feb 10;12(2):e059791. doi: 10.1136/bmjopen-2021-059791.