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临床试验/NCT03512691
NCT03512691Unknown不适用

The Nueva Ecija Cardiovascular Risk Experiment: An Evaluation of the Impact of Risk Information and Screening on Primary Prevention of Cardiovascular Disease

UPecon Foundation, Inc.2 个研究点 分布在 1 个国家目标入组 5,019 人开始时间: 2018年1月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
5,019
试验地点
2
主要终点
Mean 10-year risk of CVD event (heart attack/stroke)

研究概览

简要总结

This study seeks to assess how beliefs about health risks, specifically the risk of cardiovascular disease (CVD), affect health lifestyles and the demand for preventive care in a low-income setting. It also aims to establish the effectiveness of the Package of Essential Noncommunicable Disease Interventions in the Philippines (PhilPEN) in delivering primary prevention of CVD. To meet these objectives, the study is designed as a randomized parallel experiment with two separate, non-overlapping treatment groups and one control group. The experiment will be implemented in Nueva Ecija province, Philippines.

详细描述

This study seeks to assess how beliefs about health risks, specifically the risk of cardiovascular disease (CVD), affect health lifestyles and the demand for preventive care in a low-income setting. It also aims to establish the effectiveness of the Package of Essential Noncommunicable Disease Interventions in the Philippines (PhilPEN) in delivering primary prevention of CVD.To realize the first objective, the investigators will measure the accuracy of beliefs about exposure to CVD risk and, subsequently, randomly provide information on personal CVD risk based on measured risk factors. This will allow assessment of the extent to which biased beliefs constrain demand for primary prevention and sustain unhealthy lifestyles. In addition, the investigators will test whether beliefs about susceptibility to CVD are responsive to the receipt of information on personal risk, and whether health behaviors and the demand for CVD screening and medication are affected by any revision of beliefs.

To meet the second objective the investigators will randomly encourage uptake of the PhilPEN program's risk screening by offering entry to a money prize lottery conditional on attending a health clinic where the program operates. The induced random variation in clinic attendance will be used to estimate the program's impact on exposure to risk factors, medication of hypertension, the predicted risk of CVD and awareness of this risk.

Meeting both objectives will allow the investigators to distinguish between scenarios. One is that PhilPEN is effective in preventing CVD of patients who access the program but its impact on population health is muted because poor information on susceptibility to CVD reduces the demand for primary prevention. Another is that even if improved information is effective in raising this demand, this will have little impact on population health through PhilPEN because of deficiencies in the operation of the program in health facilities.

Within the Nueva Ecija province, the investigators will randomly sample barangays (N=304), subsequently households (n=5019) and, finally, one person aged 40-70 within each household. At the barangay level, the investigators will randomly allocate to a treatment group receiving the lottery incentive to attend a health clinic (n=2261), another treatment group receiving information on personal CVD risk (n=497) and a control group (n=2261). A baseline survey (January-April 2018) will record data on initial health, health behavior, health knowledge, risk perceptions, risk attitudes, time preferences, health care utilization and expenditure and socioeconomic characteristics, and deliver the treatments. A follow-up survey 9-12 months later will record outcomes.

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
Single (Participant)

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals aged 40-70 years old
  • Residents of Nueva Ecija province
  • Those that have been diagnosed with hypertension but are not currently (past two weeks) taking antihypertensives

排除标准

  • Individuals aged below 40 years old or above 70 years old
  • Individuals who report they have been diagnosed as having heart disease or diabetes, or who report that they have had a heart attack or a stroke
  • Those currently (past 2 weeks) taking medication for hypertension or for diabetes
  • Those who have some medical problems that prevents measurement of blood pressure or BMI

结局指标

主要结局

Mean 10-year risk of CVD event (heart attack/stroke)

时间窗: 6-9 months

Predicted probability of having a heart attack or stroke within 10 years obtained from office version of Globorisk (www.globorisk.org) based on age, sex, systolic blood pressure, body mass index (BMI) and smoking status recorded in end-point survey. Group mean of predictions will be calculated.

次要结局

  • Diet (intake of fruits, vegetables and salty foods)(6-9 months)
  • Exercise(6-9 months)
  • Proportion taking antihypertensive medication in the last 2 weeks.(6-9 months)
  • Mean systolic blood pressure (SBP)(6-9 months)
  • Proportion overweight/obese (BMI>25)(6-9 months)
  • Proportion currently smoking(6-9 months)
  • Proportion with undiagnosed hypertension(6-9 months)
  • Mean waist circumference(6-9 months)
  • Proportion with 10-year CVD risk ≥ 10%(6-9 months)
  • Proportion with elevated blood pressure (systolic ≥140)(6-9 months)
  • Mean BMI(6-9 months)
  • Alcohol consumption(6-9 months)
  • Knowledge of CVD and diabetes risk factors(6-9 months)
  • Proportion with waist circumference ≥ 90cm (men) / 80cm (women).(6-9 months)

研究者

发起方
UPecon Foundation, Inc.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joseph J. Capuno

Principal Investigator

UPecon Foundation, Inc.

研究点 (2)

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