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

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.

Study Overview

• Status: Completed
• Conditions: Asthma in Children
• Intervention / Treatment: Behavioral: Reach for Control; Behavioral: MATCH

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Children's Hospital of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Adolescent/Parent:

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

Exclusion Criteria:

Adolescent/Parent:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Reach for Control; 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
Active Comparator: Michigan MATCH; Program endorsed by the State of Michigan for treatment of poorly controlled asthma.	Behavioral: MATCH; Managing Asthma Through Case Management in Home (MATCH) is the current intervention provided by WCHAP to youth with poorly controlled asthma and their families.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family Asthma Management System Scale	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.	Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months
Asthma Symptom Frequency	Self report assessing wheezing, nighttime symptoms, speech limitations and activity limitations.	Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months

Collaborators and Investigators

• Sponsor: Wayne State University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Deborah A Ellis, Ph.D, Wayne State University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): August 8, 2023
• Study Completion (Actual): August 8, 2023

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (Actual): October 23, 2017

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Asthma management, adolescents
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 071217MP4E; R01HL138633-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available at the end of the study through presentations at scientific conferences and publications in peer-reviewed scientific journals. All final peer-reviewed manuscripts that result from the study will be submitted to PubMed Central. In addition, final dataset from the trial will be shared. Identifiers will be removed from the data prior to any release of the dataset.
• IPD Sharing Time Frame: Indefinitely
• IPD Sharing Access Criteria: In light of the sensitive nature of the treatment data contained in the data set, as well as the participation of children, data and associated documentation will be made available to users only under a specific data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying the data after analyses are completed. Furthermore, audiotaped session recordings will not be shared, as these include voice identifiers and it is not possible to de-identify the recordings; costs of transcription of sessions given their length and number are beyond the scope of the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No