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| Name | Class |
|---|---|
| University of Lausanne | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Control | No Intervention | No intervention will be introduced to the participants in this arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Information on CVD Risk | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Mean systolic blood pressure (SBP) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joseph J Capuno, PhD | Contact | 6329205465 | jjcapuno@up.edu.ph | |
| Aleli D Kraft, PhD | Contact | 6329205463 | adkraft@up.edu.ph |
| Name | Affiliation | Role |
|---|---|---|
| Joseph J Capuno, PhD | UPecon Foundation, Inc. | Principal Investigator |
| Aleli D Kraft, PhD | UPecon Foundation, Inc. | Principal Investigator |
| Owen O'Donnell, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPecon Foundation | Recruiting | Quezon City | 1101 | Philippines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Attanasio, OP (2009). Expectations and Perceptions in Developing Countries: Their Measurement and Their Use, American Economic Review, 99 (2): 87-92. | ||
| Background | 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. | ||
| Background | 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. | ||
| 24002282 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 18, 2017 | Apr 18, 2018 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
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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.
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| Lottery Incentive | Behavioral | 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. |
|
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) | 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 | 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) | 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 | 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 | 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). | 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 | 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. | 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 | 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) | A measure of health behavior consistent with those of WHO STEPS. | 6-9 months |
| Exercise | A measure of health behavior consistent with those of WHO STEPS. | 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. | 6-9 months |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| General health measured by SF-36v.1 | Measured at baseline, this is an outcome measure not specific to CVD risk. | 1-4 months |
| Labour market employment, hours and earnings | Measured at baseline, this is an outcome measure not specific to CVD risk. | 1-4 months |
| Health care utilization and expenditures | Measured at baseline, this is an outcome measure not specific to CVD risk. | 1-4 months |
| University of Lausanne |
| Principal Investigator |
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