Translating an Efficacious Illness Management Intervention for Youth With Asthma

• ClinicalTrials.gov Identifier: NCT03317977
• Recruitment Status: Active, not recruiting
• First Posted: October 23, 2017
• Last Update Posted: May 3, 2022
• Sponsor: Wayne State University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Deborah Ellis, Ph.D., Wayne State University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Asthma in Children	Behavioral: Reach for Control; Behavioral: MATCH	Not Applicable

Detailed Description:

The study will be 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. Families will be 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. 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 will be provided by community health workers (CHWs) employed by a community agency providing MATCH as their standard of care. Consent and data collection will be completed in the home at baseline with additional data collection visits at 6, 12 and 18 months after baseline. Data collection is 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 adolescent also completes a pulmonary function test on a portable spirometer and is observed using medication devices to assess asthma care skills objectively.The data analyses will be intent-to-treat, meaning that all randomized participants are included regardless of the intervention dose received. Trial data will analyzed using the linear mixed effect models.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 170 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Translating an Efficacious Illness Management Intervention for Youth With Poorly Controlled Asthma to Real World Settings
• Actual Study Start Date: February 1, 2018
• Estimated Primary Completion Date: June 30, 2022
• Estimated Study Completion Date: December 30, 2022

Arms and Interventions

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 Name: 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.

Outcome Measures

Primary Outcome Measures :

1. Pulmonary Functioning (FEV1) [ Time Frame: Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months ]
   Spirometry will be obtained using a portable calibrated recording spirometer.

Secondary Outcome Measures :

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 Device Use Skills [ Time Frame: Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months ]
   Observational measure where device use competency is rated during adolescent demonstration of use of their own quick relief and controller medication devices.
3. 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.
4. Number of emergency department visits, hospitalizations, and total hospital days [ Time Frame: Change from Baseline at 3 months, Change from Baseline at 6 months, change from Baseline at 9 months, change from Baseline at 12 months, change from Baseline at 15 months and change from Baseline at 18 months ]
   Hospitalizations will be obtained from electronic medical records and service utilization forms

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Michigan

Children's Hospital of Michigan

Detroit, Michigan, United States, 48201

Sponsors and Collaborators

Wayne State University

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Deborah A Ellis, Ph.D; Wayne State University

More Information

• Responsible Party: Deborah Ellis, Ph.D., Professor of Family Medicine and Public Health Sciences, Wayne State University
• ClinicalTrials.gov Identifier: NCT03317977
• Other Study ID Numbers: 071217MP4E; R01HL138633-01A1 ( U.S. NIH Grant/Contract )
• First Posted: October 23, 2017
• Last Update Posted: May 3, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Time Frame: Indefinitely
• Access Criteria: In light of this and 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Deborah Ellis, Ph.D., Wayne State University:

Asthma management, adolescents

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases