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The Nueva Ecija Cardiovascular Risk Experiment (NECVaRE)

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ClinicalTrials.gov Identifier: NCT03512691
Recruitment Status : Recruiting
First Posted : May 1, 2018
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
University of Lausanne
Information provided by (Responsible Party):
Joseph J. Capuno, UPecon Foundation, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Cardiovascular Risk Factor Behavioral: Information on CVD Risk Behavioral: Lottery Incentive Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5019 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study is a randomized parallel experiment with two treatment groups and one control group. Randomized assignment of treatment will be done at the level of the barangay, which is the smallest administrative unit in the Philippines roughly equivalent to an electoral ward. The 847 barangays in the Nueva Ecija province will be stratified by urban/rural classification.
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: The Nueva Ecija Cardiovascular Risk Experiment: An Evaluation of the Impact of Risk Information and Screening on Primary Prevention of Cardiovascular Disease
Actual Study Start Date : January 20, 2018
Actual Primary Completion Date : May 31, 2018
Estimated Study Completion Date : December 31, 2021

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.
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.

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.
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.

No Intervention: Control
No intervention will be introduced to the participants in this arm.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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%.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Alcohol consumption [ Time Frame: 6-9 months ]
    A measure of health behavior consistent with those of World Health Organization (WHO) STEPS.

  12. Diet (intake of fruits, vegetables and salty foods) [ Time Frame: 6-9 months ]
    A measure of health behavior consistent with those of WHO STEPS.

  13. Exercise [ Time Frame: 6-9 months ]
    A measure of health behavior consistent with those of WHO STEPS.

  14. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

  7. 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.

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. Labour market employment, hours and earnings [ Time Frame: 1-4 months ]
    Measured at baseline, this is an outcome measure not specific to CVD risk.

  13. Health care utilization and expenditures [ Time Frame: 1-4 months ]
    Measured at baseline, this is an outcome measure not specific to CVD risk.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03512691


Contacts
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Contact: Joseph J Capuno, PhD 6329205465 jjcapuno@up.edu.ph
Contact: Aleli D Kraft, PhD 6329205463 adkraft@up.edu.ph

Locations
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Philippines
UPecon Foundation Recruiting
Quezon City, Philippines, 1101
Contact: Joseph J Capuno, PhD    6329205465    jjcapuno@up.edu.ph   
Contact: Aleli D Kraft, PhD    6329205463    adkraft@up.edu.ph   
Sponsors and Collaborators
UPecon Foundation, Inc.
University of Lausanne
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Joseph J. Capuno, UPecon Foundation, Inc.:

Publications:
Attanasio, OP (2009). Expectations and Perceptions in Developing Countries: Their Measurement and Their Use, American Economic Review, 99 (2): 87-92.
Baltussen, G., Post, G. T., Van Den Assem, M. J., & Wakker, P. P. (2012). Random incentive systems in a dynamic choice experiment. Experimental Economics, 15(3), 418-443.
Camerer, C. F., Hogarth, R. M., Budescu, D. V., & Eckel, C. (1999). The effects of financial incentives in experiments: A review and capital-labor-production framework. In Elicitation of Preferences (pp. 7-48). Springer Netherlands.
Delavande A, Giné X, McKenzie D (2011a). Measuring Subjective Expectations in Developing Countries: A Critical Review and New Evidence. Journal of Development Economics, 94:151-163,
Delavande A, Giné X, McKenzie D (2011b). Eliciting Probabilistic Expectations with Visual Aids in Developing Countries: How sensitive are answers to variations in elicitation design? Journal of Applied Econometrics, 26(3):479-497.
Delavande, A. and Kohler, H-P. (2015) HIV/AIDS-related Expectations and Risky Sexual Behaviour in Malawi. Review of Economic Studies, 83: 118-64.
Department of Health (2012a). Implementing Guidelines on the Implementation of Philippine Package of Essential NCD Interventions (PHIL PEN) on the Integrated Management of Hypertension and Diabetes for Primary Care Facilities, Administrative Order No. 2012-0029. Manila: Department of Health.
Department of Health (2012b) Operations Manual on the Philippine Package of Essential NCD Interventions (PHIL PEN) on the Integrated Management of Hypertension and Diabetes for Primary Care Facilities. Manila: Department of Health.
Ezzati, M, et al. (2004). Comparative quantification of health risks. Global and regional burden of disease attributable to selected major risk factors. Volume 1. Geneva: World Health Organization.
Food and Nutrition Research Institute-Department of Science and Technology (FNRI-DOST) (2015). Philippine Nutrition Facts and Figures 2013: Clinical and Health Survey. FNRI Bldg., DOST Compound, Bicutan, Taguig City, Metro Manila, Philippines.
Hemming K and Marsch J (2013). A menu-driven facility for sample-size calculations in cluster randomized controlled trials. The Stata Journal 13(1): 114-135.
Hill, RV (2009). Using Stated Preferences and Beliefs to Identify the Impact of Risk on Poor Households. Journal of Development Studies, 45(2): 151-171.
Kahneman, D., & Tversky, A. (1979). Prospect theory: An analysis of decision under risk. Econometrica: Journal of the econometric society, 263-291.
Laibson D (1997). Golden eggs and hyperbolic discounting. Quarterly Journal of Economics 112(2): 443-477.
Paula Á.,Gil S, and Todd PE (2014). How beliefs about HIV status affect risky behaviors: evidence from Malawi. Journal of Applied Econometrics, 29: 944-964.
Prelec, D. (1998). The probability weighting function. Econometrica, 497-527.
Radcliffe, N. M., & Klein, W. M. P. (2002). Dispositional, unrealistic, and comparative optimism: Differential relations with knowledge and processing of risk information and beliefs about personal risk. Personality and Social Psychology Bulletin, 28, 836-846.
Tversky, A., & Kahneman, D. (1992). Advances in prospect theory: Cumulative representation of uncertainty. Journal of Risk and uncertainty, 5(4), 297-323.
van Wilgenburg, K, Baillon, A, O'Donnell, O and Quimbo, S (2017). Do (non-standard) risk and time preferences explain health insurance enrollment? mimeo, Erasmus School of Economics, Erasmus University Rotterdam
World Health Organization (2007) Prevention of Cardiovascular Disease: Guidelines forAssessment and Management of Cardiovascular risk. Geneva: WHO Press
World Health Organization (2010). Package of Essential Noncommunicable Disease Interventions for Primary Care in Low Resource Settings. Geneva: WHO
World Health Organization (2012) Noncommunicable diseases in the Western Pacific Region: a profile. Manila: WHO
World Health Organization (2016). HEARTS: Technical package for cardiovascular disease management in primary care. Geneva: World Health Organization.
Attanasio OP, Meghir C, Vera-Hernández, AM. (2005). Elicitation, validation, and use of probability distributions of future income in developing countries. University College; London: 2005. [unpublished working paper]

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Responsible Party: Joseph J. Capuno, Principal Investigator, UPecon Foundation, Inc.
ClinicalTrials.gov Identifier: NCT03512691     History of Changes
Other Study ID Numbers: UPecon r4d
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joseph J. Capuno, UPecon Foundation, Inc.:
Risk perceptions and attitudes, time preference, information

Additional relevant MeSH terms:
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Cardiovascular Diseases