Translating Home-Based Interventions for Adolescents With Poorly Controlled TID
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Metabolic Control: Hemoglobin A1c (HbA1c)
研究概览
简要总结
Adolescents with T1D and chronic poor metabolic control are at high risk for short and long-term diabetes complications and are heavy users of both medical resources and health care dollars. The purpose of the proposed study is to collaborate with a community agency to develop and test an intervention, Fit Families, that uses the core components of a previously successful home-based family treatment, but that can delivered by lower cost community health workers. If successful, Fit Families could improve health outcomes in a vulnerable population at high risk for diabetes complications, and could be translated to real-world treatment settings.
详细描述
The proposed study is a planning grant in which MST will be adapted for delivery by community health workers and will be conducted in collaboration with CHASS, a community agency providing health care to underserved residents of Detroit with diabetes. The new intervention, Fit Families (FF), will be tested in a pilot randomized controlled trial in order to evaluate FF feasibility, finalize outcome measures, estimate intervention effect sizes on health outcomes (i.e., youth adherence, glycemic control, quality of life) and determine potential cost savings associated with reduced hospital admissions. These steps will allow for finalization of intervention content and other trial parameters in preparation for a larger R18 dissemination trial.
The design for the proposed study is a randomized, controlled trial using a sample of 60 adolescents. Half will be randomly assigned to the treatment intervention, Fit Families plus standard medical care, and the other half will be assigned to standard medical care alone. Families who are randomized to FF receive intensive, home-based family therapy delivered by a community health worker (CHW) for approximately six months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a current hemoglobin A1c(HbA1c) of >9.0%
- •an average HbA1c of >9.0% during the past year
- •reside in the metro Detroit tri-county area
- •diagnosed with Type 1 diabetes for at least one year
- •aged 10-17
- •patient of Children's Hospital of Michigan Diabetes Clinic
排除标准
- •severe mental impairment/thought disorder
- •Active suicidality
- •Active homicidality
- •Diabetes secondary to another comorbid medical condition and/or medical management differing substantially from that of most children with diabetes.
结局指标
主要结局
Metabolic Control: Hemoglobin A1c (HbA1c)
时间窗: Change from Baseline at 7 months, Change from Baseline at 9 months
retrospective measure of blood glucose control, encompasses the previous 2-3 months
次要结局
- DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ)(Change from Baseline at 7 months, Change from Baseline at 9 months)
- Quality of life(Change from Baseline at 7 months, Change from Baseline at 9 months)
- Regimen Adherence: Diabetes Management Scale (DMS), Glucose Meter Downloads(Change from Baseline at 7 months, Change from Baseline at 9 months)
研究者
Deborah Ellis, Ph.D.
Professor of Family Medicine and Public Health Sciences Wayne State University School of Medicine
Wayne State University