HealthMap: a Cluster Randomised Trial of Interactive Health Plans and Self-management Support to Prevent Cardiovascular Disease in People With HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 731
- 试验地点
- 28
- 主要终点
- The primary study endpoint is 10-year risk of non-fatal acute myocardial infarction or coronary heart disease death as estimated by the Framingham risk equation
研究概览
简要总结
The purpose of this study is to improve the health status of people living with HIV in Australia. The overall goal is to rigorously evaluate the impact of interactive health plans and self-management support on chronic condition outcomes in people with HIV.
The specific aims are to:
Aim 1: Using a doctor-level cluster randomised trial, evaluate the effect of interactive health plans and self-management support on coronary heart disease risk and other chronic condition outcomes in people living with HIV.
Aim 2: Evaluate patient and health care provider experiences and acceptability of interactive health plans and self-management support.
Aim 3: Evaluate intervention cost-effectiveness and effect on health service utilisation.
详细描述
Participants will be consenting adults 30 years or older without evidence of cardiovascular disease.The study is a pragmatic cluster randomized controlled trial of a complex health system intervention with doctor as the unit of randomization and individual patient outcomes defined as primary and secondary endpoints. The primary endpoint will be assessed in each participant after 12 months of follow up.The study intervention will consist of a programme specifically designed for the Australian clinical context that helps people with HIV and their health care providers achieve best practice targets for modifiable cardiovascular risk factors. The programme will be available to use during routine consultations to present laboratory results, discuss health priorities and describe goals and actions. Patients will be able to access the interactive health plan from home, with associated additional resources, including online peer support. Phone and online health coaching will be available for prioritised patients wanting to reduce their cardiovascular risk. The primary objective is to determine the effect of the intervention on 10-year risk of non-fatal acute myocardial infarction or coronary heart disease death as estimated by the Framingham risk equation. The secondary objective is to alternative cardiovascular risk scores, individual modifiable cardiovascular risk factors, quality of life, mental health, self- management capacity, process and economic outcomes.
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
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- ••HIV infected adults aged 30 years or over.
- •Receiving ongoing primary HIV and general care at a study site and likely to remain in follow up at that site for 12 months.
- •Willing and able to provide written informed consent.
排除标准
- ••Diagnosed cardiovascular disease, consisting of coronary heart disease, stroke or transient ischaemia attack, or peripheral arterial disease.
- •Previous participation in a self-management or coaching program.
研究组 & 干预措施
Integrated self management support
The intervention involves the introduction of an interactive chronic disease support platform into doctor-patient consultations, in addition to a self-management support program. Specifically, the intervention comprises the following interlinked components: within consultation engagement; at home exploration; phone and web-based health coaching.
干预措施: Integrated self management support (Other)
Usual care
The control group will receive usual care from study sites until all study participants have completed 12 months of follow up from their Baseline Visits. At this point access to the study intervention will be expanded to include control sites.
结局指标
主要结局
The primary study endpoint is 10-year risk of non-fatal acute myocardial infarction or coronary heart disease death as estimated by the Framingham risk equation
时间窗: 12 months
Coronary heart disease Framingham risk equation is obtained from: Wilson P, D'Agostino R, Levy D, Belanger A, Silbershatz H, et al. (1998) Prediction of Coronary Heart Disease Using Risk Factor Categories. Circulation 97: 1837 - 1847.
次要结局
- Systolic blood pressure(12 months)
- Proportion of patients achieving HIV quality of care measures(12 months)
- Cardiovascular risk relative to age as measured by the Joint European Taskforce relative risk tables(12 months)
- Cardiovascular risk as estimated by an HIV-specific risk score(12 months)
- Fasting total cholesterol and total cholesterol:HDL ratio(12 months)
- Proportion of patients achieving Australian cardiovascular risk factor management targets(12 months)
- Quality of life as measured by the AQoL-4D instrument(12 months)
- Mental health status as measured by the DASS instrument(12 months)
- Self-management capacity as measured by the heiQ instrument(12 months)
- Body mass index and waist circumference(12 months)
- Proportion of patients with HIV virological suppression(12 months)
- Evaluation of the intervention program (intervention arm only)(12 months)
- Smoking status as measured by self-report and verified by urinary cotinine in those describing quitting during the study(12 months)
- Health care provider related: Evaluation of the intervention program intervention arm only)(12 months)
研究者
Karen Klassen
Clinical Research Fellow
Monash University