Effectiveness of Team Intervention Over 12 Months in Reducing Modifiable CVD Risk Factors on Framingham 10yr Risk Scores Outcomes in HIV-1 Subjects on Antiretroviral Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- The primary outcome measure is percentage of patients with a reduction of Framingham risk score of at least 10% at week 52.
研究概览
简要总结
This is a cohort study which follows two groups of participants over a 12 months period. One group will access a team approach to care with the aim of reducing their cardiovascular disease (CVD) risks from a team of doctors, nurses and health care professionals. The other group will continue to access standard care from their treating doctor. Both groups will have CVD risk score evaluated after a 12 month period.
The team care approach will involve specific tests to measure CVD risk as well as smoking cessation, exercise and dietary advice and support, including monitoring such as blood pressure and cholesterol levels
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •intervention study intervention arm
- •Inclusion criteria:
- •Documented HIV-1 infection
- •Age 50 years or older
- •Stable on ART ≥ 3/12
- •Undetectable plasma HIV RNA (< 50 copies/ml)
- •Moderate or high Framingham CVD risk score
- •Life expectancy > 12 months
- •Regular patient under care of non-director physician
- •Willing to adhere to pharmacological CVD risk reduction intervention
- •Willing to participate in lifestyle change advice intervention
排除标准
- •for intervention study
- •Life expectancy < 1yr
- •Unable to undertake exercise
- •Drug dependency
- •Cognitive impairment affecting ability to participate in study
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5mI U/ml)
- •Women of childbearing potential who are unwilling to use reliable contraception for the duration of the study
- •Inclusion criteria for intervention study control arm (Group 2)
- •Documented HIV-1 infection
- •Age 50 years or older
- •Stable on ART ≥3/12
- •Undetectable plasma HIV RNA (<50 copies/ml)
- •Moderate or high Framingham risk score (>10%)
- •Life expectancy > 12 months
- •Regular patient under care of non-director physician
研究组 & 干预措施
Intervention group
Patients randomised to the intervention group will follow an intensive 52 week period using a clinical protocol aimed to manage CVD risk in HIV individuals with the use of regular visits to a nurse led CVD risk management clinic, within a multi disciplinary approach to care with the involvement of treating physicians, nurses, dieticians, smoking cessation advisors and an exercise physiologist or personal trainer with the aim to reach their individualised CVD risk target.
干预措施: Control (Other)
Usual care (control) group
Within the context of an open, cohort study, GPs managing matched control patients allocated usual care will be unaware of the details of the intervention arm and asked to apply their usual pattern of patient visits and treatment strategies to achieve optimal reduction of CVD risk.
干预措施: Intervention Group (Other)
结局指标
主要结局
The primary outcome measure is percentage of patients with a reduction of Framingham risk score of at least 10% at week 52.
时间窗: 12 months
The primary outcome measure is percentage of patients with a reduction of Framingham risk score of at least 10% at week 52.
次要结局
未报告次要终点
研究者
Dr. Mark Bloch
Doctor
Holdsworth House Medical Practice