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

Asthma in Children Clinical Trial

— IMPACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04908384
• Other study ID #: STUDY00010461
• Secondary ID: KL2TR0023171R21N
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: August 15, 2023

Study information

• Verified date: May 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: August 15, 2023
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Behavioral:
• Improving Asthma Care Together (IMPACT)
IMPACT is a novel health application and wearable device

Locations

Country	Name	City	State
United States	University of Washington School of Nursing	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	National Center for Advancing Translational Sciences (NCATS), National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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