Translating an Efficacious Illness Management Intervention for Youth With Poorly Controlled Asthma to Real World Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Number of Emergency Department Visits
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescent/Parent:
- •Child aged 12 years, 0 months to 16 years, 11 months
- •Moderate to severe persistent asthma
- •Child seen in the CHM emergency department for treatment of asthma exacerbation
- •Child has experienced 2 or more ED visits and/ or inpatient admissions in prior 12 months (i.e. poorly controlled asthma)
- •Parent/ legal guardian willing to participate in home-based family treatment
- •Child and family resides within 20 miles of CHM (allows for home-based data collection and intervention)
排除标准
- •Adolescent/Parent:
- •Child is currently in an out-of-home placement
- •Schizophrenia or other psychosis on the part of the youth or parent
- •Current suicidality or homicidality on the part of the youth or parent
- •Cognitive impairment or learning disability that prevents comprehension of research measures on the part of parent or youth
结局指标
主要结局
Number of Emergency Department Visits
时间窗: Change from Baseline at 6 months, 12 months, and 18 months
Emergency department visits will be obtained from electronic medical records
次要结局
- Family Asthma Management System Scale(Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months)
- Asthma Symptom Frequency(Change from Baseline at 6 months, change from Baseline at 12 months and change from Baseline at 18 months)
研究者
Deborah Ellis, Ph.D.
Professor of Family Medicine and Public Health Sciences
Wayne State University