Translating an Efficacious Illness Management Intervention for Youth With Asthma

Asthma in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03317977
• Other study ID #: 071217MP4E
• Secondary ID: R01HL138633-01A1
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: August 8, 2023

Study information

• Verified date: April 2024
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 8, 2023
• Est. primary completion date: August 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital of Michigan	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Wayne State University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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