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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
104
IMPACT is a novel health application and wearable device
University of Washington School of Nursing
Seattle, Washington, United States
Asthma Responsibility Questionnaire Change From Baseline to 8 Weeks
10- items, 5-point scale to report asthma management task responsibility. Total score is the mean of all items calculated. Scores range from 1 to 5, with 1= parent takes responsibility all of the time, 3= parent and child share responsibility about equally, and 5 = child takes responsibility all of the time.
Time frame: Baseline and 8 weeks
Asthma Responsibility Questionnaire Change From 8 to 16 Weeks
10- items, 5-point scale to report asthma management task responsibility. Total score is the mean of all items calculated. Scores range from 1 to 5, with 1= parent takes responsibility all of the time, 3= parent and child share responsibility about equally, and 5 = child takes responsibility all of the time.
Time frame: 8 and 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. Scores are averaged with higher scores indicate higher self-efficacy. Possible range of 1-5.
Time frame: Baseline and 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. Scores are averaged and higher scores indicate higher self-efficacy. Possible score range of 1-5.
Time frame: 8 and 16 weeks
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 forced expiratory volume in one second/forced vital capacity (FEV1/FVC) measure will be used and interpreted according to the national spirometry guideline cutpoints (NAEPP EPR4 report). Scores are presented as a percentage and typically range from 1% to 120% (occasionally higher), with higher scores indicating better asthma control. Note, national asthma guidelines consider \>85% to indicate well controlled asthma.
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Time frame: Baseline and 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 forced expiratory volume in one second/forced vital capacity (FEV1/FVC) measure will be used and interpreted according to the national spirometry guideline cutpoints (NAEPP EPR4 report). Scores are presented as a percentage and typically range from 1% to 120% (occasionally higher), with higher scores indicating better asthma control. Note, national asthma guidelines consider \>85% to indicate well controlled asthma.
Time frame: 8 and 16 weeks
Childhood Asthma Control Test Change From Baseline to 8 Weeks
7 total items--3 parent (5-point scale) and 4 child (3-point scale) to assess asthma control. Parent and child scores are summed, possible range of 7-27, with higher scores indicate better control. One total score reported for child participants.
Time frame: Baseline and 8 weeks
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) to assess asthma control. Parent and child scores are summed, possible range of 7-27, with higher scores indicate better control. One total score reported for child participants.
Time frame: 8 and 16 weeks
Childhood Asthma Quality of Life Change From Baseline to 8 Weeks
Self-report child (13 items)- asthma quality of life, scores range from 1-7 per item, a mean of item scores calculated, with higher scores indicating better quality of life. Possible score range of 1-7.
Time frame: Baseline and 8 weeks
Childhood Asthma Quality of Life Change From 8 Weeks to 16 Weeks
Self-report child (13 items)- asthma quality of life, scores range from 1-7 per item, a mean of item scores calculated, with higher scores indicating better quality of life. Possible score range of 1-7.
Time frame: 8 and 16 weeks
Parent Asthma Quality of Life Change From Baseline to 8 Weeks
Parent/caregiver (13 items)-reported asthma quality of life, scores range from 1-7 per item, a mean of item scores calculated, with higher scores indicating better quality of life. Score range of variable, which required exponential transformation for negatively skewed distribution, was 2.72-43.35, with higher scores indicating worse quality of life.
Time frame: Baseline and 8 weeks
Parent Asthma Quality of Life Change From 8 Weeks to 16 Weeks
Parent/caregiver (13 items)-reported asthma quality of life, scores range from 1-7 per item, a mean of item scores calculated, with higher scores indicating better quality of life. Score range of variable, which required exponential transformation for negatively skewed distribution, was 2.72-345.90, with higher scores indicating worse quality of life.
Time frame: 8 and 16 weeks
Acceptability of Intervention Measure (Intervention Groups Only)
4 items (2 for children) using 5-point scale; scores are summed with higher scores indicate higher acceptability. Possible score range of 4-20 for parents, 2-10 for children.
Time frame: 8 weeks
Medication Adherence Change From Baseline to 8 Weeks
Medication Adherence Report Scale for Asthma, 10-items, 5-point scale assessing reported child asthma controller medication adherence at baseline and throughout the study. Higher adherence suggests better asthma management. Scores are averaged, ranging from 1-5, with higher scores indicating better adherence.
Time frame: Baseline and 8 weeks
Medication Adherence Change From 8 Weeks to 16 Weeks
Medication Adherence Report Scale for Asthma, 10-items, 5-point scale assessing reported child asthma controller medication adherence at baseline and throughout the study. Higher adherence suggests better asthma management. Scores are averaged, ranging from 1-5, with higher scores indicating better adherence.
Time frame: 8 and 16 weeks
Feasibility of Intervention (Intervention Group Only)
4 items (2 for children) using 5-point scale; scores are summed with higher scores indicate higher feasibility. Possible score range of 4-20 for parents, 2-10 for children.
Time frame: 8 weeks
System Usability Scale (Intervention Group Only)
System usability scale - 10 items, 5-point scale to determine perceived usability of a system. To calculate the SUS score, first sum the score contributions from each item. Each item's score contribution will range from 0 to 4. For items 1,3,5,7,and 9 the score contribution is the scale position minus 1. For items 2,4,6,8 and 10, the contribution is 5 minus the scale position. Multiply the sum of the scores by 2.5 to obtain the overall value of SU. Total score may range from 0 to 100 with higher scores indicating higher usability. Used only post-intervention.
Time frame: 8 weeks