Management of Hypertension and Multiple Risk Factors to Enhance Cardiovascular Health - A Cluster Randomized Pilot Trial in SingHealth Polyclinics, Singapore
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Change in Systolic Blood Pressure from baseline to final follow-up at 3 months
研究概览
简要总结
High blood pressure (BP) is a serious public health problem responsible for heart attack, stroke and kidney failure. One in four adults in Singapore has hypertension. We propose a pilot study in 2 polyclinics in Singapore, 1 deliver a structured multi-component intervention and another usual care. A total of 100 adults with uncontrolled high blood pressure will be followed for 3 months. The intervention includes 1) algorithm-driven antihypertensive treatment for all patients using fixed-dose combination and lipid lowering for high risk patients, 2) motivational conversation for high risk patients; and 3) telephone based follow-ups of all patients by a team of physician supervised nurse practitioners and nurses. The change in BP will be compared between intervention and control groups. The structured care including the above mentioned components is likely to be more effective than usual care in lowering BP levels of patients with uncontrolled high blood pressure. Such a program is also likely to be more cost effective in terms of money spent for improving quality of patients' life. The findings of the pilot will inform the design of a larger cluster randomized trial in eight polyclinics in Singapore. If the main study is successful, the findings will be informative for policymakers to roll out intervention in all polyclinics and primary care centers across Singapore, and other countries with similar healthcare infrastructure.
详细描述
- Background:
Cardiovascular diseases (CVD) are the leading cause of disability and death in Singapore, and consume substantial healthcare resources. Uncontrolled hypertension confers the highest attributable risk of CVD. About one in four adults suffer from hypertension in Singapore, 50% of them have uncontrolled blood pressure (BP), and management is especially sub-optimal among those with concomitant diabetes or dyslipidemia. Evidence suggests that well structured programs of care delivery are effective in lowering BP and preventing CVD. However, there is lack of empirical data on such strategies in Singapore.
The findings of the pilot will inform the design of a larger cluster randomized trial in eight polyclinics in Singapore. If proven effective in the main study, the information will be valuable in convincing the policy-makers to upscale strategies for enhancing management of hypertension and cardiovascular health within the primary health infrastructure of Singapore, and possibly neighbouring Southeast Asian countries. 2. Aims:
Specific aim 1: To explore logistics for delivery of provider training in intervention algorithm and motivational counselling while maintaining optimal efficiency of ongoing clinical work at the polyclinics.
Specific aim 2: To establish recruitment of participants in the intervention and usual care groups, and uptake of each component of the multicomponent intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 years or older
- •Singapore citizen and Permanent Resident
- •Individuals visiting the recruiting polyclinic at least twice during the last 1 year
- •Individuals with with previously diagnosed hypertension and uncontrolled blood pressure (Systolic BP 140 mmHg and above and diastolic BP 90 mmHg)
排除标准
- •Individuals with active systemic illness including fever
- •Individuals with recent hospitalization (i.e. during last 4 months),
- •Individuals with clinically unstable heart failure (i.e. Ejection fraction <20% or complaint of shortness of breath at rest)
- •Individuals with advanced kidney disease (i.e. estimated Chronic kidney disease (CKD) -Epi glomerular filtration rate <40 ml/min/1.73m2 or nephrotic range proteinuria (i.e. 3g/d or more))
- •Individuals with known advanced liver disease (i.e. Child-Pugh Stage C)
- •Individuals with pregnancy
- •Individuals with any other major debilitating disease or
- •Individuals with mental illness that precludes validity of informed consent
结局指标
主要结局
Change in Systolic Blood Pressure from baseline to final follow-up at 3 months
时间窗: Baseline, month 3
次要结局
- Proportion of planned orientation sessions delivered(Baseline)
- Percent of data (laboratory and medication) retrieved from the polyclinic electronic database(At month 3)
- Proportion of participants recruited(Baseline)
- Percent uptake of motivational interviewing sessions(3 months)
- Proportion of blood pressure readings obtained at final follow-up(At month 3)
研究者
Professor Tazeen Jafar
Professor
Duke-NUS Graduate Medical School