Translating an Efficacious Illness Management Intervention for Youth With Asthma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Asthma in Children
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 12 years and 16 years
- Gender
- Both males and females
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 M...
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.
Tracking Information
- NCT #
- NCT03317977
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Principal Investigator: Deborah A Ellis, Ph.D Wayne State University