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: July 28, 2023

Study information

• Verified date: November 2023
• 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: 52
• Est. completion date: July 28, 2023
• Est. primary completion date: November 30, 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, 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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
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, higher scores indicate higher selfefficacy.	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, higher scores indicate higher selfefficacy.	16 weeks
Secondary	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
Secondary	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
Secondary	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)
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 FEV1/FVC measure will be used and interpreted according to the national spirometry guideline cutpoints (NAEPP EPR4 report)	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 FEV1/FVC measure will be used and interpreted according to the national spirometry guideline cutpoints (NAEPP EPR4 report)	16 weeks
Secondary	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)
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)-- assess asthma control, higher scores indicate better control	8 weeks
Secondary	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)
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)-- assess asthma control, higher scores indicate better control	16 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Acceptability of intervention measure	4 items using 5-point scale; higher scores indicate higher acceptability.	8 weeks
Secondary	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
Secondary	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
Secondary	Feasibility of intervention (intervention group only)	Feasibility of intervention 4-items, 5-point scale, with higher scores indicating higher feasibility.	8 weeks
Secondary	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
Secondary	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