Translating an Efficacious Illness Management Intervention for Youth With Asthma

NCT03317977 | Completed Results DMC

• 2 other identifiers: 071217MP4ER01HL138633-01A1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma in Children

Keywords

Asthma management, adolescents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Family Asthma Management System Scale

  Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months

• Asthma Symptom Frequency

  Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months

Study Arms (2)

Reach for Control

EXPERIMENTAL

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

Michigan MATCH

ACTIVE COMPARATOR

Program endorsed by the State of Michigan for treatment of poorly controlled asthma.

Behavioral: MATCH

Interventions

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

Also known as: RFC

Reach for Control

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.

Michigan MATCH

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wayne State University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Results Point of Contact

• Title: Deborah Ellis, Ph.D.
• Organization: Wayne State University

dellis@med.wayne.edu

313-577-1055

Study Officials

• Deborah A Ellis, Ph.D

  Wayne State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Family Medicine and Public Health Sciences

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 23, 2017
• Study Start: February 1, 2018
• Primary Completion: August 8, 2023
• Study Completion: August 8, 2023
• Last Updated: April 4, 2024
• Results First Posted: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Indefinitely
• 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.

Locations

US (1)