Cardiovascular DiseasesNECVaRENCT03512691
The Nueva Ecija Cardiovascular Risk Experiment
A study testing Information on CVD Risk and Lottery Incentive in people with Cardiovascular Diseases and Cardiovascular Risk Factor, run by UPecon Foundation, Inc. at 1 site in Philippines.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Cardiovascular Risk Factor
- What is being tested?
- Information on CVD Risk and Lottery Incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,019 participants
- Where
- 1 sitePhilippines
- Study dates
- 20 Jan 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Philippines1 site, 1 recruiting
- Recruiting
UPecon Foundation
Quezon City, 1101
Joseph J Capuno, PhD, 6329205465, jjcapuno@up.edu.ph
Aleli D Kraft, PhD, 6329205463, adkraft@up.edu.ph
About this study
Official title: 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.
Read the 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.
- Being tested
- Information on CVD Risk, Lottery Incentive
- Keywords
- Risk perceptions and attitudes, time preference, information
- Medical subject headings
- Cardiovascular Diseases, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information on CVD RiskBehavioural
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 IncentiveBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Information on CVD risk | Experimental | 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. Receives: Behavioral: Information on CVD Risk |
| Lottery Incentive | Experimental | 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. Receives: Behavioral: Lottery Incentive |
| Control | No intervention | No intervention will be introduced to the participants in this arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-9 months
Secondary outcomes (14)
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%.
Measured: 6-9 months
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.
Measured: 6-9 months
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.
Measured: 6-9 months
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.
Measured: 6-9 months
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.
Measured: 6-9 months
Proportion currently smoking
Predicted CVD risk is function of blood pressure, BMI and smoking. We will also estimate effects on these risk factors separately.
Measured: 6-9 months
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.
Measured: 6-9 months
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.
Measured: 6-9 months
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.
Measured: 6-9 months
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.
Measured: 6-9 months
Alcohol consumption
A measure of health behavior consistent with those of World Health Organization (WHO) STEPS.
Measured: 6-9 months
Diet (intake of fruits, vegetables and salty foods)
A measure of health behavior consistent with those of WHO STEPS.
Measured: 6-9 months
Exercise
A measure of health behavior consistent with those of WHO STEPS.
Measured: 6-9 months
Knowledge of CVD and diabetes risk factors
Knowledge of CVD and diabetes risk factors assessed using questions adapted from previously fielded instruments.
Measured: 6-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start20 Jan 2018
- Primary completion31 May 2018
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (53)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 5,019 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UPecon Foundation, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne
- Responsible party
- Principal investigator, Joseph J. Capuno, UPecon Foundation, Inc.
- Investigators
- Joseph J Capuno, PhD, Principal investigator, UPecon Foundation, Inc.Aleli D Kraft, PhD, Principal investigator, UPecon Foundation, Inc.Owen O'Donnell, PhD, Principal investigator, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512691
- Sponsor's protocol ID
- UPecon r4d
- Acronym
- NECVaRE
- Status last verified
- Apr 2019
- First submitted
- 18 Apr 2018
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
Chow CK, Teo KK, Rangarajan S, Islam S, Gupta R, Avezum A, Bahonar A, Chifamba J, Dagenais G, Diaz R, Kazmi K, Lanas F, Wei L, Lopez-Jaramillo P, Fanghong L, Ismail NH, Puoane T, Rosengren A, Szuba A, Temizhan A, Wielgosz A, Yusuf R, Yusufali A, McKee M, Liu L, Mony P, Yusuf S; PURE (Prospective Urban Rural Epidemiology) Study investigators. Prevalence, awareness, treatment, and control of hypertension in rural and urban communities in high-, middle-, and low-income countries. JAMA. 2013 Sep 4;310(9):959-68. doi: 10.1001/jama.2013.184182.
PubMed 24002282Cooney MT, Dudina AL, Graham IM. Value and limitations of existing scores for the assessment of cardiovascular risk: a review for clinicians. J Am Coll Cardiol. 2009 Sep 29;54(14):1209-27. doi: 10.1016/j.jacc.2009.07.020.
PubMed 19778661D'Agostino RB Sr, Vasan RS, Pencina MJ, Wolf PA, Cobain M, Massaro JM, Kannel WB. General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation. 2008 Feb 12;117(6):743-53. doi: 10.1161/CIRCULATIONAHA.107.699579. Epub 2008 Jan 22.
PubMed 18212285Delavande 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, Kohler HP. Subjective expectations in the context of HIV/AIDS in Malawi. Demogr Res. 2009 Jun 23;20:817-874. doi: 10.4054/DemRes.2009.20.31.
PubMed 19946378Delavande, 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.
Dimmock SG, Kouwenberg R, Mitchell OS, Peijnenburg K. Estimating ambiguity preferences and perceptions in multiple prior models: Evidence from the field. J Risk Uncertain. 2015 Dec;51(3):219-244. doi: 10.1007/s11166-015-9227-2. Epub 2015 Dec 16.
PubMed 26924890Otgontuya D, Oum S, Buckley BS, Bonita R. Assessment of total cardiovascular risk using WHO/ISH risk prediction charts in three low and middle income countries in Asia. BMC Public Health. 2013 Jun 5;13:539. doi: 10.1186/1471-2458-13-539.
PubMed 23734670Ezzati, 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Nueva Ecija Cardiovascular Risk Experiment: An Evaluation of the Impact of Risk Information and Screening on Primary Prevention of Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT03512691
- Acronym / sponsor ID
- NECVaRE / UPecon r4d
- Keywords
- Risk perceptions and attitudes, time preference, information
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,019 participants (estimated)
- Lead sponsor
- UPecon Foundation, Inc.University, hospital or other
- Collaborators
- University of Lausanne
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 1 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Information on CVD risk | Experimental | Behavioral: Information on CVD RiskRespondents 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. |
| Lottery Incentive | Experimental | Behavioral: Lottery IncentiveRespondents 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. |
| Control | No intervention | –No intervention will be introduced to the participants in this arm. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Information on CVD RiskRespondents 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. | Behavioural | Information on CVD risk |
| Lottery IncentiveRespondents 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. | Behavioural | Lottery Incentive |
Primary outcome
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.
14 secondary outcomes
Proportion with 10-year CVD risk ≥ 10%
Time frame: 6-9 months
Mean systolic blood pressure (SBP)
Time frame: 6-9 months
Proportion with elevated blood pressure (systolic ≥140)
Time frame: 6-9 months
Mean BMI
Time frame: 6-9 months
Proportion overweight/obese (BMI>25)
Time frame: 6-9 months
Proportion currently smoking
Time frame: 6-9 months
Mean waist circumference
Time frame: 6-9 months
Proportion with waist circumference ≥ 90cm (men) / 80cm (women).
Time frame: 6-9 months
Proportion with undiagnosed hypertension
Time frame: 6-9 months
Proportion taking antihypertensive medication in the last 2 weeks.
Time frame: 6-9 months
Alcohol consumption
Time frame: 6-9 months
Diet (intake of fruits, vegetables and salty foods)
Time frame: 6-9 months
Exercise
Time frame: 6-9 months
Knowledge of CVD and diabetes risk factors
Time frame: 6-9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- BackgroundAttanasio, OP (2009). Expectations and Perceptions in Developing Countries: Their Measurement and Their Use, American Economic Review, 99 (2): 87-92.
- BackgroundBaltussen, 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.
- BackgroundCamerer, 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.
- Background: PubMed 24002282Chow CK, Teo KK, Rangarajan S, Islam S, Gupta R, Avezum A, Bahonar A, Chifamba J, Dagenais G, Diaz R, Kazmi K, Lanas F, Wei L, Lopez-Jaramillo P, Fanghong L, Ismail NH, Puoane T, Rosengren A, Szuba A, Temizhan A, Wielgosz A, Yusuf R, Yusufali A, McKee M, Liu L, Mony P, Yusuf S; PURE (Prospective Urban Rural Epidemiology) Study investigators. Prevalence, awareness, treatment, and control of hypertension in rural and urban communities in high-, middle-, and low-income countries. JAMA. 2013 Sep 4;310(9):959-68. doi: 10.1001/jama.2013.184182.
- Background: PubMed 19778661Cooney MT, Dudina AL, Graham IM. Value and limitations of existing scores for the assessment of cardiovascular risk: a review for clinicians. J Am Coll Cardiol. 2009 Sep 29;54(14):1209-27. doi: 10.1016/j.jacc.2009.07.020.
- Background: PubMed 18212285D'Agostino RB Sr, Vasan RS, Pencina MJ, Wolf PA, Cobain M, Massaro JM, Kannel WB. General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation. 2008 Feb 12;117(6):743-53. doi: 10.1161/CIRCULATIONAHA.107.699579. Epub 2008 Jan 22.
- BackgroundDelavande 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,
- BackgroundDelavande 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.
- Background: PubMed 19946378Delavande A, Kohler HP. Subjective expectations in the context of HIV/AIDS in Malawi. Demogr Res. 2009 Jun 23;20:817-874. doi: 10.4054/DemRes.2009.20.31.
- BackgroundDelavande, A. and Kohler, H-P. (2015) HIV/AIDS-related Expectations and Risky Sexual Behaviour in Malawi. Review of Economic Studies, 83: 118-64.
- BackgroundDepartment 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.
- BackgroundDepartment 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph J Capuno, PhD principal investigator
UPecon Foundation, Inc.
Aleli D Kraft, PhD principal investigator
UPecon Foundation, Inc.
Owen O'Donnell, PhD principal investigator
University of Lausanne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information on CVD Risk and Lottery Incentive in people with Cardiovascular Diseases and Cardiovascular Risk Factor, run by UPecon Foundation, Inc. at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joseph J Capuno, PhD (6329205465, jjcapuno@up.edu.ph), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean 10-year risk of CVD event (heart attack/stroke) (time frame: 6-9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03512691, which also lists 53 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.