Development of a Multiple Health Behavior Change Intervention for Cardiovascular Risk Reduction Among People Who Have Experienced Homelessness: The CV-HOMES Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Acceptability Measured by the Client Satisfaction Questionnaire
研究概览
简要总结
This single-arm trial of the Cardiovascular Risk Reduction Among People Experiencing Homelessness (CV-Homes) intervention alone (n=8) will test the perception and feasibility of anticipated study procedures.
详细描述
This study is of a set of studies with an overall goal to develop and pilot test a collaborative care intervention using motivational interviewing and behavioral activation alongside education and psychosocial support to improve medication adherence tailored to the experiences of people experiencing homelessness and cardiovascular health risks (CV-H). Our team's central hypothesis is that medication adherence and cardiovascular self-care (and eventual glycemic control, cholesterol control, health care use/cost) will improve with an intervention tailored to the unique context of CV-H.
This protocol addresses a pilot study to test patient perceptions of the feasibility and acceptability of study procedures and refine the CV-Homes treatment manual through test cases (n=8). With a hypothesis that the CV-Homes manual and study procedures will be feasible and acceptable to CV-H as measured by self-report and post-treatment interview.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Age 18 yrs. or older
- •English-speaking
- •Living at Catholic Charities' Endeavors residence (Minneapolis, MN)
- •Self-reported diagnosis of moderate or high CVD risk, defined as being told by a medical professional that the participant has hypertension, heart disease, hypercholesterolemail, prediabetes, or type 2 diabetes
- •Plan to stay in local area or be reachable by phone for the next 16 weeks
- •Willingness to work on one or more CVD risk reduction behavior change
排除标准
- •Active intoxication
- •Active psychosis
- •Presence of a legal guardian
- •Pregnant or lactating people
结局指标
主要结局
Acceptability Measured by the Client Satisfaction Questionnaire
时间窗: at 16 weeks
This will be assessed at the end of the intervention using the 8-item Client Satisfaction Questionnaire, with a score range 8-32, higher score indicating greater satisfaction.
Treatment Engagement Measured by Sessions Attended
时间窗: At 16 weeks
Throughout the study we will measure engagement by tracking attendance of treatment sessions.
次要结局
- Health-related Quality of Life(Baseline to 16 weeks)
- Cardiovascular Health (AHA Life's Essential 8)(Baseline to 16 weeks)
研究者
Katherine Vickery
Katherine Vickery, MD
Hennepin Healthcare Research Institute