Vet COACH (Veteran Peer Coaches Optimizing and Advancing Cardiac Health)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 264
- 试验地点
- 2
- 主要终点
- Change in Systolic Blood Pressure (SBP)
研究概览
简要总结
The purpose of this study is to test if having a Veteran peer health coach will improve blood pressure control among Veterans with high blood pressure and at least one other Cardiovascular disease (CVD) risk factor. The intervention will deliver brief health messages, discuss goal setting, and action planning around health behavior changes shown to decrease CVD risk, including healthy diet, regular to moderate-intensity physical activity, and smoking cessation. Facilitators, barriers, and costs of the intervention will be determined.
详细描述
The Vet-COACH study is a peer health coaching program to help reduce Cardiovascular disease (CVD) risk among Veterans. The goal of the study is to test the effectiveness of a home-visit peer health coach intervention to promote health outcomes and behavior change among Veterans with multiple CVD risk factors with a hybrid type 1 implementation study. The study will focus on Veterans with poorly controlled hypertension and at least one other CVD risk factor to target a high risk population.
The study will conduct a randomized controlled trial to enroll n=400 Veterans to compare a peer health coach intervention consisting of home visits, telephone support, and linkages to appropriate community-based and clinic resources compared to usual VHA primary care. The primary outcome is reduction in systolic blood pressure from baseline to follow-up at 1-year. Secondary outcomes include a reduction in Framingham Cardiovascular risk score, individual cardiovascular risks (tobacco use, lipids), health related quality of life, and health care use. The investigators will also assess the effects of the peer health coach intervention on intermediate outcomes including social support, patient activation, patient/provider communication and health behaviors (e.g. medication adherence, physical activity, nutrition, alcohol use, and stress management). The cost of the intervention will be assessed to inform feasibility for future studies, determine Veteran and staff satisfaction with the intervention, and identify barriers and facilitators to adoption.
Note, the intermediate outcomes were not prespecified in the protocol for evaluation and were not specified in the grant, protocol paper, or in our SAP as outcomes and were removed from results analysis.
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
盲法说明
N/A; No masking will occur in this clinical trial.
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be a Veteran
- •Have > 1 visit to VA Puget Sound Health Care Center(Seattle or American Lake VA) primary care or women's clinic in the past year
- •Poorly controlled hypertension (> 150/90 mmHg)
- •At least one other CVD risk (including overweight or obesity, body mass index > 25 kg/m2, tobacco use, hyperlipidemia LDL-c > 130 mg/dL)
排除标准
- •Hospitalization in the past 3 months for cardiovascular-related conditions (IHD, Cerebral Vascular Accident [CVA], PVD)
- •Severe illness that precludes lifestyle program, end-stage renal disease (ESRD) on dialysis
- •Nursing home resident, homeless
- •Severe cognitive impairment
- •Receiving home-based primary care (including VA Home Tele-Health and patients who received palliative care or are enrolled in hospice care)
结局指标
主要结局
Change in Systolic Blood Pressure (SBP)
时间窗: Baseline to follow-up at 1 year
Change in systolic blood pressure (SBP) from baseline to 12-months. Blood pressure readings were obtained using standard procedures with a blood pressure monitor to obtain a mean SBP score of 3 blood pressure measurements. An increased reduction in mean SBP indicates a better outcome.
次要结局
- Framingham Cardiovascular Risk Score (FRS)(Baseline to follow-up at 1 year)
- Body Mass Index (BMI)(Baseline to follow-up at 1 year)
- Low Density Lipoprotein Cholesterol (LDL-c).(Baseline to follow-up at 1 year)
- Change in Health-Related Quality of Life (HRQoL), Mental Component Summary Score(Baseline to follow-up at 1 year)
- Number of Hospitalizations(Baseline to follow-up at 1 year)
- Number of Emergency Room (ER) Visits(Baseline to follow-up at 1 year)
- Current Tobacco Use(Current tobacco use measured at Baseline and Follow up at one year)
- Change in Health-Related Quality of Life (HRQoL), Physical Component Summary Score (PCS)(Baseline to follow-up at 1 year)
- Number of Outpatient Clinic/Primary Care Visits(Baseline to follow-up at 1 year)