Translating an Efficacious Illness Management Intervention for Youth With Asthma

Clinical Trial ID: NCT03317977

Description

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.

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.


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

  • Start Date

    2018-02-01

  • Last Updated

    2018-04-30

  • Sponsor

    National Heart, Lung, and Blood Institute (NHLBI)

  • Condition Name

    Asthma in Children

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