Cardiac Rehabilitation for Cardiovascular Risk Reduction in People With Severe and Persistent Mental Illness: A Pilot Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Efficacy outcome
研究概览
简要总结
The goal of this prospective, randomized trial is to explore the link between cardiovascular disease and mortality in individuals with severe and persistent mental illness (SPMI). The main question it aims to answer is: Is a primary prevention cardiac rehabilitation intervention feasible and effective at reducing cardiovascular risk in people with a primary psychotic disorder or bipolar disorder?"
Participants will undergo a multi-component primary prevention intervention program. Researchers will compare with a control group to see if cardiovascular risk reduction is attained.
详细描述
This prospective, randomized study aims to recruit 46 adults with schizophrenia, schizoaffective disorder, or bipolar disorder, who are classified as intermediate or high 10-year risk for a cardiovascular event, into a multi-component cardiac rehabilitation intervention program. The aim is to explore the feasibility and efficacy of this multi-component primary prevention intervention program in reducing cardiovascular risk in individuals with SPMI.
Evidence supports a high burden of cardiovascular disease and mortality in individuals with SPMI. In link, multiple studies outline disparities in access to quality cardiovascular care in people with SPMI. Given the high CV risk factor burden in people with SPMI and the disparity in access and quality of care, there is a need to screen for CV risk factors and initiate and monitor guideline-directed therapies in people with SPMI.
Intervention outcomes will be measured using the Framingham 10-year cardiovascular risk score, the Framingham 30-year cardiovascular risk score, the PRIMOSE BMI and Lipid risk scores, the EQ-5D-5L scale and the CGI score. Continuous variables will be displayed as means, with associated standard deviations. Categorical variables will be represented as frequencies and percentages. Subsequent comparative analysis will take place, where the overall cohort will be characterized into high risk (top quartile) and low risk (bottom quartile) cohorts. This will be accomplished using the chi-squared test or the Fisher exact test, along with the student's t test and the Mann-Whitney U test when appropriate. SPSS 24.0 will be the statistical software used.
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 (Outcomes Assessor)
盲法说明
Masking the participant and provider is not possible due to the nature of the intervention
入排标准
- 年龄范围
- 30 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 30 to 59 years old
- •Psychiatric diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder
- •2 or more cardiac risk behaviors or conditions: smoking, obese, hypertension, diabetes, metabolic syndrome, dyslipidemia, obstructive sleep apnea
- •10-year Framingham cardiovascular risk score of ≥ 10% (intermediate risk)
- •Willing to participate in cardiac rehabilitation program
排除标准
- •Psychiatric instability, as judged by treating psychiatrist
- •Distance from cardiac rehabilitation centre that would preclude participation
- •Unsafe to participate in the cardiac rehabilitation intervention, as judged by the cardiology assessment
- •Known coronary artery disease, cerebrovascular disease, or peripheral vascular disease
- •Court ordered mandatory or tutor
结局指标
主要结局
Efficacy outcome
时间窗: 9 months
10-year Framingham cardiovascular risk score
次要结局
- 30-year Cardiovascular risk(9 months)
- PRIMROSE BMI risk score(9 months)
- Quality of life(9 months)
- PRIMROSE Lipid risk score(9 months)
研究者
Michael Goldfarb
Attending Staff, Division of Cardiology
Lady Davis Institute