Heart Outcomes Prevention and Evaluation 4 (HOPE-4)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,438
- 试验地点
- 7
- 主要终点
- The mean difference in change in Framingham Risk Score (FRS) between the intervention and control communities from baseline to 1 year.
研究概览
简要总结
The overall objective of the HOPE-4 Phases (HT and CVD) is to develop, implement and evaluate an evidence-based, contextually appropriate programme for cardiovascular disease (CVD) risk assessment, treatment and control involving: (1) simplified algorithms implemented by non-physician health workers (NPHW) and supported by e-health technologies (tablets programmed with decision and counselling support software); (2) initiation of evidence-based cardiovascular (CV) medications and (3) treatment supporters to optimize long-term medication and lifestyle adherence.
详细描述
Study design: open-label, parallel cluster randomized controlled trial design.
HT Phase: Up to 30 urban and rural communities in Canada, Colombia and Malaysia will be randomized to participate in an intensive CV risk detection and control programme by NPHW or to care as usual for 12 months. NOTE: Canada will serve as a pilot study, which will be used to evaluate feasibility, time, cost and program improvements.
CVD Phase: If funded, this phase will be a continuation and expansion of HT Phase to include up to 190 urban and rural communities in countries within Asia, South America, Sub-Saharan Africa, and Canada that will be allocated to participate in an intensive CV risk detection and control programme supported by NPHWs or to care as usual for up to 6 years. NOTE: CVD Phase - currently not initiated.
Communities will be randomized 1:1 with a central randomization system to either a) intervention or b) control, after screening in the community is complete.
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
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
- •Individuals (≥ 50 years) with at least ONE of the following criteria:
- •SBP ≥160 mmHg in one visit
- •SBP 140-159 mmHg in one visit AND participant-reported medical diagnosis of hypertension
- •SBP 140-159 mmHg in one visit AND participant taking anti-HT medication
- •SBP ≥130 mmHg in one visit AND participant-reported medical diagnosis of diabetes
- •SBP ≥130 mmHg in one visit AND participant taking medication for diabetes
- •Participants that do not meet criteria 1-5 AND SBP 140-159 mmHg in one visit AND SBP ≥140 mmHg in a second visit ≥24 hours apart
排除标准
- •Refusal to Consent
- •Actively involved in any study or heart health program that would compromise the protocol of HOPE-4
- •Severe co-morbid condition with life expectancy < 1 year
- •Other serious condition(s) or logistic factors likely to interfere with study participation or with the ability to complete the trial, as appropriate to country or region.
研究组 & 干预措施
Intervention
Intensive CV risk detection, counselling and follow-up program by NPHW; recommended CV medications will include combinations of anti-hypertensive medications (both low and high doses) and a lipid lowering agent (e.g. statin) in accordance with treatment algorithm [precise formulations used may differ in each country]; use of treatment supporters to reinforce adherence.
干预措施: Intervention (Other)
Control - Usual Care
Participants in control communities will be referred to usual care.
干预措施: Usual Care (Other)
结局指标
主要结局
The mean difference in change in Framingham Risk Score (FRS) between the intervention and control communities from baseline to 1 year.
时间窗: Baseline to 1 year (HT phase)
Difference in major CV events [CV death, CV hospitalizations (e.g. MI, Stroke, AF, unstable or new onset angina, CHF, arterial revascularization), and end-stage renal disease] at 6 years.
时间窗: Undetermined - currently not initiated and is dependent on funding (CVD Phase).
次要结局
- Change in systolic BP (SBP) between the intervention and control communities at 6 and 12 months(Baseline to 6 months and 12 months (HT Phase))
- Proportion of participants with well-controlled blood pressure at 6 and 12 months (SBP < 140 mmHg in non-diabetics and SBP < 130 mmHg in diabetics(Baseline to 6 months and 12 months (HT Phase))
- Change in HDL, LDL, total cholesterol, triglycerides, and glucose levels at 12 months(Baseline to 1 year (HT Phase))
- Change in smoking status at 6 and 12 months(Baseline to 6 months and 12 months (HT Phase))
- Medication adherence measures at 6 and 12 months(Baseline to 6 months and 12 months (HT Phase))
- Clinical events (e.g. death, CVD development, hospitalizations) at 6 and 12 months(Baseline to 6 months and 12 months (HT Phase))
- Country-specific process outcomes at 6 and 12 months(Baseline to 6 months and 12 months (HT Phase))
- Change in individual components of the primary outcomes in the HT Phase(Undetermined - currently not initiated and is dependent on funding (CVD Phase))
- Change in IHRS at 6 and 12 months and ChRS at 12 months(Baseline to 6 months and 12 months (HT Phase))
- Number of participants receiving prescriptions for (or taking) anti-hypertensive medications (as an indication of physician adherence to treatment guidelines) at 6 and 12 months(Baseline to 6 months and 12 months (HT Phase))
- Secondary outcomes from the HT Phase(Undetermined - currently not initiated and is dependent on funding (CVD Phase))