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Completed

NCT Number: NCT03317977

Translating an Efficacious Illness Management Intervention for Youth With Asthma

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.

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Key information

Conditions

Asthma in Children

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reach for Control

Behavioral

In 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

Other names: RFC

MATCH

Behavioral

Managing Asthma Through Case Management in Home (MATCH) is the current intervention provided by WCHAP to youth with poorly controlled asthma and their families.

Primary outcomes

  1. Number of Emergency Department Visits

    Time frame: Change from Baseline at 6 months, 12 months, and 18 months

    Emergency department visits will be obtained from electronic medical records

Secondary outcomes

  1. Family Asthma Management System Scale

    Time frame: 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.

  2. Asthma Symptom Frequency

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Oct 23, 2017
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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