Translating an Efficacious Illness Management Intervention for Youth With Asthma

Not Applicable

Completed

Conditions: Asthma in Children

Interventions: Behavioral: MATCH
Behavioral: Reach for Control

Registration Number: NCT03317977

Lead Sponsor: Wayne State University

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 75

Inclusion Criteria

Adolescent/Parent:

Child aged 12 years, 0 months to 16 years, 11 months
Moderate to severe persistent asthma
Child seen in the CHM emergency department for treatment of asthma exacerbation
Child has experienced 2 or more ED visits and/ or inpatient admissions in prior 12 months (i.e. poorly controlled asthma)
Parent/ legal guardian willing to participate in home-based family treatment
Child and family resides within 20 miles of CHM (allows for home-based data collection and intervention)

Exclusion Criteria

Adolescent/Parent:

Child is currently in an out-of-home placement
Schizophrenia or other psychosis on the part of the youth or parent
Current suicidality or homicidality on the part of the youth or parent
Cognitive impairment or learning disability that prevents comprehension of research measures on the part of parent or youth

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Michigan MATCH	MATCH	Program endorsed by the State of Michigan for treatment of poorly controlled asthma.
Reach for Control	Reach for Control	Reach For Control is a multi-component, home-based family therapy that targets the multiple causes of poor adolescent asthma management across individual, family and community systems.

Primary Outcome Measures

Name	Time	Method
Number of Emergency Department Visits	Change from Baseline at 6 months, 12 months, and 18 months	Emergency department visits will be obtained from electronic medical records

Secondary Outcome Measures

Name	Time	Method
Family Asthma Management System Scale	Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months	Identifies family strengths and weaknesses in the management of pediatric asthma across a variety of domains. This is a semi-structured interview that is rated on seven to nine 9-point subscales with higher scores indicating better management. The rating manual provides elaboration and brief examples at key anchor points for each rating scale. A FAMSS summary score is computed for each family by taking a mean across all subscales.
Asthma Symptom Frequency	Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months	Self report assessing wheezing, nighttime symptoms, speech limitations and activity limitations.