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

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.

Study Overview

• Status: Completed
• Conditions: Asthma in Children
• Intervention / Treatment: Behavioral: Improving Asthma Care Together (IMPACT)

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 Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington School of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 11 years (Child)
• Accepts Healthy Volunteers: No

Description

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, attention deficit hyperactivity disorder (ADHD)
• Current asthma exacerbation at the time of recruitment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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. 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.	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.	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.	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.	8 and 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family functioning change from baseline to 8 weeks	McMaster Family Assessment Device, 60-item parent-report instrument, 4-point scale to evaluate family functioning. Higher scores indicate worsened levels of functioning.	8 weeks
Family functioning change from 8 weeks to 16 weeks	McMaster Family Assessment Device, 60-item parent-report instrument, 4-point scale to evaluate family functioning. Higher scores indicate worsened levels of functioning.	16 weeks
Illness perception change from baseline to 8 weeks	Brief Illness Perception Questionnaire, 8-items, 10-point scale to assess individual beliefs about a health condition. Higher scores indicate more burdensome perception.	8 weeks
Illness perception change from 8 weeks to 16 weeks	Brief Illness Perception Questionnaire, 8-items, 10-point scale to assess individual beliefs about a health condition. Higher scores indicate more burdensome perception.	16 weeks
Medication Beliefs change from baseline to 8 weeks	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.	8 weeks
Medication Beliefs change from 8 weeks to 16 weeks	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.	16 weeks

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Nursing Research (NINR); National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Jennifer T Sonney, PhD, University of Washington

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): August 15, 2023

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: mHealth; Self-management; Shared management
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: STUDY00010461; KL2TR002317 (U.S. NIH Grant/Contract); 1R21NR019328 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No