Clinical Trials Directory

Trials / Completed

CompletedNCT03317977

Translating an Efficacious Illness Management Intervention for Youth With Asthma

Translating an Efficacious Illness Management Intervention for Youth With Poorly Controlled Asthma to Real World Settings

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
75 (actual)
Sponsor
Wayne State University · Academic / Other
Sex
All
Age
12 Years – 16 Years
Healthy volunteers
Not accepted

Summary

The propose of the study is to test the effectiveness of Reach for Control (RFC) as compared to Michigan MATCH to improve asthma symptoms, asthma management and lung functioning and to decrease ED visits and admissions for youth with poorly controlled asthma when integrated into hospital emergency departments and delivered by community health workers. The study is a hybrid implementation-effectiveness design and will test RFC for use in real world, public healthcare settings.

Detailed description

The study was conducted in the emergency department at Children's Hospital of Michigan; CHM). 170 adolescents with poorly controlled asthma and their primary caregivers will be enrolled. Prior to the COVID-19 pandemic, families were randomly assigned to six months of home-based family treatment consisting of either RFC or Michigan MATCH , a model program endorsed by the State of Michigan for treatment of poorly controlled asthma. Subsequently, all intervention content in both arms was delivered by telehealth. Treatment content of RFC consists of weekly sessions focusing on asthma education, asthma management skills, improving home-school community for asthma, access to care and case management. MATCH includes asthma education but is less intensive and does not focus on family management skills. Treatment was provided by community health workers (CHWs) employed by a community agency providing MATCH as their standard of care. Consent and data collection was completed at baseline with additional data collection visits at 6, 12 and 18 months after baseline. Data collection was completed by project research assistants and consists of questionnaires and interviews with the adolescent and parent to assess asthma management, asthma symptoms and hospital utilization. The data analyses were intent-to-treat, meaning that all randomized participants are included regardless of the intervention dose received. Trial data were analyzed using linear mixed effect models.

Conditions

Interventions

TypeNameDescription
BEHAVIORALReach for ControlIn Phase 1 (weeks 1-4), the CHW conducts an initial intake and then completes a comprehensive functional analysis (FA) of behavior to determine the causes of poor asthma management for each youth regarding asthma management. In Phase 2 (weeks 5-20) is a treatment phase and consists of a combination of mandatory cognitive-behavioral skills training (CBST) modules (received by all families) and flexible CBST modules chosen and individualized based on the results of the Phase 1 FA. This includes but not limited to In-vivo Asthma Skills Training, Improving Family Communication and Behavioral Contracting. Phase 3 (weeks 21-24) involves termination planning and relapse prevention
BEHAVIORALMATCHManaging Asthma Through Case Management in Home (MATCH) is the current intervention provided by WCHAP to youth with poorly controlled asthma and their families.

Timeline

Start date
2018-02-01
Primary completion
2023-08-08
Completion
2023-08-08
First posted
2017-10-23
Last updated
2024-04-04
Results posted
2024-04-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03317977. Inclusion in this directory is not an endorsement.