The Nueva Ecija Cardiovascular Risk Experiment (NECVaRE)

April 15, 2019 updated by: Joseph J. Capuno, UPecon Foundation, Inc.

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

5019

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Quezon City, Philippines, 1101
        • Recruiting
        • UPecon Foundation
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Information on CVD risk
Respondents will receive information on the predicted probability of having a heart attack or stroke within 10 years. The predictions will be obtained from the Globorisk tool (www.globorisk.org). All information will be provided within a risk perceptions module of the baseline survey. Only this module will differ across the two treatment groups (information and lottery) and the control group. Information obtained from earlier modules will be retrieved automatically and used to make predictions of CVD risk consistent with the risk factor profile of the respondent.
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.
Experimental: Lottery Incentive
Respondents will be offered a ticket for a lottery with a money prize on condition that they visit a specific public health clinic for a checkup. There will be one prize per barangay giving each respondent a one in ten chance of winning P5000 (US$100). The prize is equivalent to approximately 14 days earnings at the regional minimum wage.
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.
No Intervention: Control
No intervention will be introduced to the participants in this arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean 10-year risk of CVD event (heart attack/stroke)
Time Frame: 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.
6-9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion with 10-year CVD risk ≥ 10%
Time Frame: 6-9 months
Predicted risk obtained from Globorisk as for primary outcome. If power permits, will also estimate effects on proportion with CVD risk>20% and >30%.
6-9 months
Mean systolic blood pressure (SBP)
Time Frame: 6-9 months
Predicted CVD risk is function of blood pressure, BMI and smoking. We will also estimate effects on these risk factors separately. Mean of last two SBP measures on single visit. BP measured using electronic (OMRON) wrap cuff monitor.
6-9 months
Proportion with elevated blood pressure (systolic ≥140)
Time Frame: 6-9 months
Predicted CVD risk is function of blood pressure, BMI and smoking. We will also estimate effects on these risk factors separately. Mean of last two SBP measures on single visit. BP measured using electronic (OMRON) wrap cuff monitor.
6-9 months
Mean BMI
Time Frame: 6-9 months
Predicted CVD risk is function of blood pressure, BMI and smoking. We will also estimate effects on these risk factors separately. Height and weight measured using standardized instruments.
6-9 months
Proportion overweight/obese (BMI>25)
Time Frame: 6-9 months
Predicted CVD risk is function of blood pressure, BMI and smoking. We will also estimate effects on these risk factors separately. Height and weight measured using standardized instruments.
6-9 months
Proportion currently smoking
Time Frame: 6-9 months
Predicted CVD risk is function of blood pressure, BMI and smoking. We will also estimate effects on these risk factors separately.
6-9 months
Mean waist circumference
Time Frame: 6-9 months
Globorisk predicted 10-year CVD risk is not a function of central adiposity, but this is measured as part of PhilPEN risk assessment. Weight circumference will be measured followed a standardized procedure.
6-9 months
Proportion with waist circumference ≥ 90cm (men) / 80cm (women).
Time Frame: 6-9 months
Globorisk predicted 10-year CVD risk is not a function of central adiposity, but this is measured as part of PhilPEN risk assessment. Weight circumference will be measured followed a standardized procedure.
6-9 months
Proportion with undiagnosed hypertension
Time Frame: 6-9 months
A measure of diagnosis and medication of hypertension. Numerator = systolic/diastolic BP ≥ 140/90 + not diagnosed with hypertension. Denominator = all respondents.
6-9 months
Proportion taking antihypertensive medication in the last 2 weeks.
Time Frame: 6-9 months
A measure of diagnosis and medication of hypertension. Numerator = systolic/diastolic BP ≥ 140/90 + not diagnosed with hypertension. Denominator = all respondents.
6-9 months
Alcohol consumption
Time Frame: 6-9 months
A measure of health behavior consistent with those of World Health Organization (WHO) STEPS.
6-9 months
Diet (intake of fruits, vegetables and salty foods)
Time Frame: 6-9 months
A measure of health behavior consistent with those of WHO STEPS.
6-9 months
Exercise
Time Frame: 6-9 months
A measure of health behavior consistent with those of WHO STEPS.
6-9 months
Knowledge of CVD and diabetes risk factors
Time Frame: 6-9 months
Knowledge of CVD and diabetes risk factors assessed using questions adapted from previously fielded instruments.
6-9 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of smokers/ex-smokers who have been advised by a doctor or health worker to quit smoking
Time Frame: 6-9 months
For the lottery intervention, we will examine whether attending a health clinic for a checkup increases the probability of receiving medical advice on the adoption of healthier habits, as is prescribed by the PhilPEN protocol.
6-9 months
Proportion of smokers/ex-smokers who have received counselling on smoking cessation
Time Frame: 6-9 months
For the lottery intervention, we will examine whether attending a health clinic for a checkup increases the probability of receiving medical advice on the adoption of healthier habits, as is prescribed by the PhilPEN protocol.
6-9 months
Proportion who have been advised by a doctor or other health worker to drink less alcohol (out of all who have ever consumed alcohol)
Time Frame: 6-9 months
For the lottery intervention, we will examine whether attending a health clinic for a checkup increases the probability of receiving medical advice on the adoption of healthier habits, as is prescribed by the PhilPEN protocol.
6-9 months
Proportion who have been advised by a doctor or other health worker to eat less salty and/or fatty food
Time Frame: 6-9 months
For the lottery intervention, we will examine whether attending a health clinic for a checkup increases the probability of receiving medical advice on the adoption of healthier habits, as is prescribed by the PhilPEN protocol.
6-9 months
Proportion who have been advised by a doctor or other health worker to eat more fruit and vegetables and/or grains and pulses
Time Frame: 6-9 months
For the lottery intervention, we will examine whether attending a health clinic for a checkup increases the probability of receiving medical advice on the adoption of healthier habits, as is prescribed by the PhilPEN protocol.
6-9 months
Proportion who have been advised by a doctor or other health worker to be more physically active
Time Frame: 6-9 months
For the lottery intervention, we will examine whether attending a health clinic for a checkup increases the probability of receiving medical advice on the adoption of healthier habits, as is prescribed by the PhilPEN protocol.
6-9 months
Proportion of individuals overweight or obese (at baseline) who have been encouraged by a health professional to lose weight
Time Frame: 6-9 months
For the lottery intervention, we will examine whether attending a health clinic for a checkup increases the probability of receiving medical advice on the adoption of healthier habits, as is prescribed by the PhilPEN protocol.
6-9 months
Mean perceived 10-year risk of heart attack or stroke for someone of same age and sex as respondent
Time Frame: 1-4 months
This outcome will be measured in the baseline survey in response to information provided during the interview
1-4 months
Mean perceived own 10-year risk of heart attack or stroke
Time Frame: 1-4 months
This outcome will be measured in the baseline survey in response to information provided during the interview.
1-4 months
Mean perceived own 10-year risk of heart attack or stroke if were to adopt healthy lifestyle
Time Frame: 1-4 months
This outcome will be measured in the baseline survey in response to information provided during the interview.
1-4 months
General health measured by SF-36v.1
Time Frame: 1-4 months
Measured at baseline, this is an outcome measure not specific to CVD risk.
1-4 months
Labour market employment, hours and earnings
Time Frame: 1-4 months
Measured at baseline, this is an outcome measure not specific to CVD risk.
1-4 months
Health care utilization and expenditures
Time Frame: 1-4 months
Measured at baseline, this is an outcome measure not specific to CVD risk.
1-4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Joseph J Capuno, PhD, UPecon Foundation, Inc.
  • Principal Investigator: Aleli D Kraft, PhD, UPecon Foundation, Inc.
  • Principal Investigator: Owen O'Donnell, PhD, University of Lausanne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2018

Primary Completion (Actual)

May 31, 2018

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

April 18, 2018

First Submitted That Met QC Criteria

April 18, 2018

First Posted (Actual)

May 1, 2018

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPecon r4d

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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