Conditional Cash Transfer Intervention to Improve Health Outcomes Among Inner-City African Americans With T2DM
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Glycemic control (HbA1c)
研究概览
简要总结
This study will test the preliminary efficacy of diabetes-tailored CCT (DM-CCT), which will be conditional on participating in biweekly (every two weeks), nurse-led, virtual diabetes education/skills training and stress/coping intervention compared to UCT (with no requirement for participation) on clinical outcomes, self-care behaviors, and psychological health in 100 inner city AAs with poorly controlled T2DM using an RCT design. The aims of the proposed study include:
AIM 1: Test the preliminary efficacy of the DM-CCT intervention on glycemic control and quality of life for inner-city AAs with T2DM.
AIM 2: Test the preliminary efficacy of the DM-CCT intervention on self-care behaviors and psychological health for inner-city AAs with T2DM.
AIM 3: Estimate the cost of delivery of the DM-CCT and UCT interventions in preparation for future cost effectiveness analysis.
详细描述
The overarching aim of this proposal is to test the preliminary efficacy of diabetes-tailored CCT (DM-CCT conditional on participating in biweekly, nurse-led, virtual diabetes education/skills training and stress/coping intervention) compared to UCT (with no requirement for participation) on clinical outcomes, self-care behaviors, and psychological health in inner city African Americans with poorly controlled T2DM. One hundred (100) individuals will be randomized to either the DM-CCT intervention or the UCT intervention and followed for 6-months, with study visits at baseline, 3-months, and 6-months. The primary outcomes will be glycemic control (HbA1c) and quality of life (SF-12) at 6-months post randomization. The secondary outcomes will be self-care behaviors (diet, exercise, medication adherence) and psychological health (stress, coping) measured at 6-months post randomization. In preparation for future cost effectiveness studies, the final aim will estimate the cost of delivery of the DM-CCT and UCT interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •Self-report as African American
- •Clinical diagnosis of T2DM and HbA1c ≥8% at the screening visit
- •Residence in inner city zip codes
- •Income greater or equal to133% of federal poverty level or Medicaid eligible
- •Able to communicate in English.
排除标准
- •Mental confusion on interview suggesting significant dementia
- •Alcohol or drug abuse/dependency
- •Active psychosis or acute mental disorder
- •Participation in other diabetes clinical trials
- •Life expectancy <6 months
结局指标
主要结局
Glycemic control (HbA1c)
时间窗: Change from baseline HbA1c at 6 months post intervention follow-ups
Blood specimens (10cc of blood) will be obtained by trained phlebotomists or nurse for HbA1c.
Quality of Life as measured by SF-12
时间窗: Change from baseline quality of life measure at 6 months post intervention follow-ups
The SF-12 (Ware 1996) is a valid and reliable instrument to measure functional status and reproduces 90% of the variance in PCS-36 and MCS-36 scores.
次要结局
- Self-Care(Change from baseline self-care at 6 months post intervention follow-ups)
研究者
Jennifer Annette Campbell
Associate Professor
State University of New York at Buffalo