N/A N=104 Randomized Single-blind Prevention

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

Asthma in Children

Bottom Line

View on ClinicalTrials.gov: NCT04908384 ↗

Enrolled (actual)

104

Serious AEs

0.0%

Results posted

Jun 2024

Primary outcome: Primary: Asthma Responsibility Questionnaire Change From Baseline to 8 Weeks — 2.72; 2.72; 2.79; 2.31 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Improving Asthma Care Together (IMPACT) (Behavioral)
Age: Pediatric · 7+ yrs
Sex: All
Sponsor: University of Washington
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Asthma Responsibility Questionnaire Change From Baseline to 8 Weeks	2.72; 2.72; 2.79; 2.31	—
PRIMARY Asthma Responsibility Questionnaire Change From 8 to 16 Weeks	2.88; 2.63; 2.90; 2.4	—
PRIMARY Asthma Management Self-efficacy Change From Baseline to 8 Weeks	3.79; 4.27; 3.74; 4.41	—
PRIMARY Asthma Management Self-efficacy Change From 8 Weeks to 16 Weeks	3.69; 4.36; 3.49; 4.52	—
SECONDARY Spirometry - FEV1/FVC Change From Baseline to 8 Weeks	85.18; 82.87	—
SECONDARY Spirometry - FEV1/FVC Change From 8 Weeks to 16 Weeks	85.38; 81.82	—
SECONDARY Childhood Asthma Control Test Change From Baseline to 8 Weeks	12.46; 12.78	—
SECONDARY Childhood Asthma Control Test Change From 8 Weeks to 16 Weeks	12.93; 12.14	—
SECONDARY Childhood Asthma Quality of Life Change From Baseline to 8 Weeks	5.74; 5.97	—
SECONDARY Childhood Asthma Quality of Life Change From 8 Weeks to 16 Weeks	5.56; 5.98	—
SECONDARY Parent Asthma Quality of Life Change From Baseline to 8 Weeks	11.56; 7.08	—
SECONDARY Parent Asthma Quality of Life Change From 8 Weeks to 16 Weeks	12.85; 17.44	—
SECONDARY Acceptability of Intervention Measure (Intervention Groups Only)	8; 14.42	—
SECONDARY Medication Adherence Change From Baseline to 8 Weeks	3.20; 3.30; 3.70; 3.25	—
SECONDARY Medication Adherence Change From 8 Weeks to 16 Weeks	3.32; 3.04; 3.78; 3.65	—
SECONDARY Feasibility of Intervention (Intervention Group Only)	8; 14.37	—
SECONDARY System Usability Scale (Intervention Group Only)	68.95; 62.5	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04908384). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.