The Nueva Ecija Cardiovascular Risk Experiment

Cardiovascular Diseases Clinical Trial

— NECVaRE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03512691
• Other study ID #: UPecon r4d
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2019
• Source: UPecon Foundation, Inc.
• Contact: Joseph J Capuno, PhD
• Phone: 6329205465
• Email: jjcapuno[@]up.edu.ph
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5019
• Est. completion date: December 31, 2021
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Risk Factor

Intervention

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.
• 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.

Locations

Country	Name	City	State
Philippines	UPecon Foundation	Quezon City

Sponsors (2)

Lead Sponsor	Collaborator
UPecon Foundation, Inc.	University of Lausanne

Country where clinical trial is conducted

Philippines, 

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* Note: There are 52 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of smokers/ex-smokers who have been advised by a doctor or health worker to quit smoking	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
Other	Proportion of smokers/ex-smokers who have received counselling on smoking cessation	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
Other	Proportion who have been advised by a doctor or other health worker to drink less alcohol (out of all who have ever consumed alcohol)	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
Other	Proportion who have been advised by a doctor or other health worker to eat less salty and/or fatty food	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
Other	Proportion who have been advised by a doctor or other health worker to eat more fruit and vegetables and/or grains and pulses	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
Other	Proportion who have been advised by a doctor or other health worker to be more physically active	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
Other	Proportion of individuals overweight or obese (at baseline) who have been encouraged by a health professional to lose weight	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
Other	Mean perceived 10-year risk of heart attack or stroke for someone of same age and sex as respondent	This outcome will be measured in the baseline survey in response to information provided during the interview	1-4 months
Other	Mean perceived own 10-year risk of heart attack or stroke	This outcome will be measured in the baseline survey in response to information provided during the interview.	1-4 months
Other	Mean perceived own 10-year risk of heart attack or stroke if were to adopt healthy lifestyle	This outcome will be measured in the baseline survey in response to information provided during the interview.	1-4 months
Other	General health measured by SF-36v.1	Measured at baseline, this is an outcome measure not specific to CVD risk.	1-4 months
Other	Labour market employment, hours and earnings	Measured at baseline, this is an outcome measure not specific to CVD risk.	1-4 months
Other	Health care utilization and expenditures	Measured at baseline, this is an outcome measure not specific to CVD risk.	1-4 months
Primary	Mean 10-year risk of CVD event (heart attack/stroke)	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	Proportion with 10-year CVD risk = 10%	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
Secondary	Mean systolic blood pressure (SBP)	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
Secondary	Proportion with elevated blood pressure (systolic =140)	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
Secondary	Mean BMI	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
Secondary	Proportion overweight/obese (BMI>25)	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
Secondary	Proportion currently smoking	Predicted CVD risk is function of blood pressure, BMI and smoking. We will also estimate effects on these risk factors separately.	6-9 months
Secondary	Mean waist circumference	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
Secondary	Proportion with waist circumference = 90cm (men) / 80cm (women).	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
Secondary	Proportion with undiagnosed hypertension	A measure of diagnosis and medication of hypertension. Numerator = systolic/diastolic BP = 140/90 + not diagnosed with hypertension. Denominator = all respondents.	6-9 months
Secondary	Proportion taking antihypertensive medication in the last 2 weeks.	A measure of diagnosis and medication of hypertension. Numerator = systolic/diastolic BP = 140/90 + not diagnosed with hypertension. Denominator = all respondents.	6-9 months
Secondary	Alcohol consumption	A measure of health behavior consistent with those of World Health Organization (WHO) STEPS.	6-9 months
Secondary	Diet (intake of fruits, vegetables and salty foods)	A measure of health behavior consistent with those of WHO STEPS.	6-9 months
Secondary	Exercise	A measure of health behavior consistent with those of WHO STEPS.	6-9 months
Secondary	Knowledge of CVD and diabetes risk factors	Knowledge of CVD and diabetes risk factors assessed using questions adapted from previously fielded instruments.	6-9 months