Rural Intervention for Caregivers' Heart Health (RICHH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 311
- 试验地点
- 2
- 主要终点
- Change in Blood Pressure in mmHg
研究概览
简要总结
The investigators are testing a two-group, randomized, controlled trial with 280 primary caregivers of adult patients with a chronic illness to test the efficacy of the Rural Intervention for Caregivers' Heart Health (RICHH). Immediate (4-month) and long-term (12-month) effects of the RICHH intervention on CVD risk factors, self-management behaviors, and depressive symptoms will be compared to usual care. The investigators also will test the moderating effect of gender on intervention outcomes, given the many differences between male and female caregivers.
Specific Aim 1: To determine effects of the RICHH intervention on the primary outcomes of CVD risk factors (i.e., lipid profile, body mass index, and blood pressure) at 4 and 12 months.
Hypotheses 1: The intervention group will have better lipid profile, body mass index, and blood pressure outcomes than the usual care group at 4 and 12 months.
Specific Aim 2: To determine effects of the RICHH intervention on self-management behaviors (i.e., diet quality, physical activity level, and self-report adherence to specific CVD health behaviors).
Hypotheses 2: The intervention group will have better diet quality, higher physical activity levels, and better adherence to specific CVD health behaviors than the usual care group at 4 and 12 months.
Specific Aim 3: To determine effects of RICHH on depressive symptoms at 4 and 12 months.
Hypotheses 3: Caregivers receiving the intervention will have lower levels of depressive symptoms than caregivers receiving usual care at 4 and 12 months.
Specific Aim 4: To evaluate whether intervention effects on outcomes will differ by caregivers' gender.
Hypotheses 4: Effects will be stronger for male compared to female caregivers at 4 and 12 months.
Impact: The proposed study will have a substantial impact on caregivers' cardiovascular health and quality of life because it will provide needed CVD risk prevention, and health promotion to rural caregivers living in distressed environments where CVD risk reduction and self-management is difficult. The intervention holds the potential to produce major improvements in health among caregivers living in rural environments in the US.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •primary family rural caregiver of patients with chronic illnesses
- •provided care for the patient for > 6 months
- •no cognitive impairment that would preclude understanding the consent process
排除标准
- •chronic drug abuse
- •current active cancer
- •any physical or emotional impairment that limits participants' abilities to engage in self-management or that is likely to result in needing a caregiver in the next 12 months.
结局指标
主要结局
Change in Blood Pressure in mmHg
时间窗: Baseline, 4 and 12 months
blood pressure
Change in Lipid Profile Derived from point-of-care testing
时间窗: Baseline, 4 and 12 months
lipid profile from point-of-care testing
Change in Body Mass Index (kg/m2) calculated from height and weight
时间窗: Baseline, 4 and 12 months
body mass index calculated from height and weight
次要结局
- Change in Physical Activity Level (steps per 24 hours) measured by actigraphy(Baseline, 4 and 12 months)
- Change in Depressive Symptoms(Baseline, 4 and 12 months)
- Change in Adherence measured using the Specific Adherence Scale score from Medical Outcomes Study(Baseline, 4 and 12 months)
- Change in Diet Quality measured by the Food Frequency Questionnaire(Baseline, 4 and 12 months)
研究者
Debra Moser
Sponsor/PI
University of Kentucky