Trials / Unknown

UnknownNCT03512691

The Nueva Ecija Cardiovascular Risk Experiment

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

Status: Unknown
Phase: N/A
Study type: Interventional
Enrollment: 5,019 (estimated)

Sponsor: UPecon Foundation, Inc. · Academic / Other
Sex: All
Age: 40 Years – 70 Years
Healthy volunteers: Accepted

Summary

Detailed description

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.

Conditions

Interventions

Type	Name	Description
BEHAVIORAL	Information on CVD Risk	Respondents will be provided three types of information on CVD risks: a CVD base rate, a personalized CVD risk and an optimal CVD risk. The CVD base rate will be predicted from the respondent's age and sex only. After reporting their own chance of having a heart attack or stroke within ten years, the respondents in the treatment group will be told the risk for someone with the same age, sex, smoking status, body mass index (BMI) and blood pressure as them. Finally, a treatment group respondent will receive information on what the 10-year CVD risk would be for someone of the same age and gender who did not smoke, and had normal blood pressure and BMI.
BEHAVIORAL	Lottery Incentive	Respondents will simply be told that they can enter a lottery if they go to the specified clinic for a checkup. The health facilities will be told to conduct an assessment deemed appropriate for any particular patient that requests to be issued with a lottery ticket. No instructions will be given that the facilities should follow the PhilPEN protocol. We will evaluate whether they do implement the protocol for patients who qualify (by age if nothing else) for full risk screening.

Timeline

Start date: 2018-01-20
Primary completion: 2018-05-31
Completion: 2021-12-31
First posted: 2018-05-01
Last updated: 2019-04-17

Locations

1 site across 1 country: Philippines

Source: ClinicalTrials.gov record NCT03512691. Inclusion in this directory is not an endorsement.