Translating an Efficacious Illness Management Intervention for Youth With Asthma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03317977|
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : April 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Asthma in Children||Behavioral: Reach for Control Behavioral: MATCH||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 :||June 30, 2022|
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.
Managing Asthma Through Case Management in Home (MATCH) is the current intervention provided by WCHAP to youth with poorly controlled asthma and their families.
- 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.
- 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.
- 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.
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317977
|Contact: Raqhuel Williams, B.Afirstname.lastname@example.org|
|Contact: Deborah A Ellis, Ph.Demail@example.com|
|United States, Michigan|
|Children's Hospital of Michigan||Recruiting|
|Detroit, Michigan, United States, 48201|
|Contact: Nirupama Kannikeswaran, MD|
|Principal Investigator:||Deborah A Ellis, Ph.D||Wayne State University|