The Nueva Ecija Cardiovascular Risk Experiment (NECVaRE)
15. april 2019 opdateret af: 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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
5019
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Quezon City, Filippinerne, 1101
- Rekruttering
- UPecon Foundation
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Kontakt:
- Joseph J Capuno, PhD
- Telefonnummer: 6329205465
- E-mail: jjcapuno@up.edu.ph
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Kontakt:
- Aleli D Kraft, PhD
- Telefonnummer: 6329205463
- E-mail: adkraft@up.edu.ph
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
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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.
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Eksperimentel: 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.
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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.
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Ingen indgriben: Control
No intervention will be introduced to the participants in this arm.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Mean 10-year risk of CVD event (heart attack/stroke)
Tidsramme: 6-9 months
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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.
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6-9 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Proportion with 10-year CVD risk ≥ 10%
Tidsramme: 6-9 months
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Predicted risk obtained from Globorisk as for primary outcome.
If power permits, will also estimate effects on proportion with CVD risk>20% and >30%.
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6-9 months
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Mean systolic blood pressure (SBP)
Tidsramme: 6-9 months
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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.
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6-9 months
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Proportion with elevated blood pressure (systolic ≥140)
Tidsramme: 6-9 months
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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.
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6-9 months
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Mean BMI
Tidsramme: 6-9 months
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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.
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6-9 months
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Proportion overweight/obese (BMI>25)
Tidsramme: 6-9 months
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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.
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6-9 months
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Proportion currently smoking
Tidsramme: 6-9 months
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Predicted CVD risk is function of blood pressure, BMI and smoking.
We will also estimate effects on these risk factors separately.
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6-9 months
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Mean waist circumference
Tidsramme: 6-9 months
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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.
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6-9 months
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Proportion with waist circumference ≥ 90cm (men) / 80cm (women).
Tidsramme: 6-9 months
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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.
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6-9 months
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Proportion with undiagnosed hypertension
Tidsramme: 6-9 months
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A measure of diagnosis and medication of hypertension.
Numerator = systolic/diastolic BP ≥ 140/90 + not diagnosed with hypertension.
Denominator = all respondents.
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6-9 months
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Proportion taking antihypertensive medication in the last 2 weeks.
Tidsramme: 6-9 months
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A measure of diagnosis and medication of hypertension.
Numerator = systolic/diastolic BP ≥ 140/90 + not diagnosed with hypertension.
Denominator = all respondents.
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6-9 months
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Alcohol consumption
Tidsramme: 6-9 months
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A measure of health behavior consistent with those of World Health Organization (WHO) STEPS.
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6-9 months
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Diet (intake of fruits, vegetables and salty foods)
Tidsramme: 6-9 months
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A measure of health behavior consistent with those of WHO STEPS.
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6-9 months
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Exercise
Tidsramme: 6-9 months
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A measure of health behavior consistent with those of WHO STEPS.
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6-9 months
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Knowledge of CVD and diabetes risk factors
Tidsramme: 6-9 months
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Knowledge of CVD and diabetes risk factors assessed using questions adapted from previously fielded instruments.
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6-9 months
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Proportion of smokers/ex-smokers who have been advised by a doctor or health worker to quit smoking
Tidsramme: 6-9 months
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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.
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6-9 months
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Proportion of smokers/ex-smokers who have received counselling on smoking cessation
Tidsramme: 6-9 months
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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.
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6-9 months
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Proportion who have been advised by a doctor or other health worker to drink less alcohol (out of all who have ever consumed alcohol)
Tidsramme: 6-9 months
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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.
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6-9 months
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Proportion who have been advised by a doctor or other health worker to eat less salty and/or fatty food
Tidsramme: 6-9 months
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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.
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6-9 months
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Proportion who have been advised by a doctor or other health worker to eat more fruit and vegetables and/or grains and pulses
Tidsramme: 6-9 months
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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.
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6-9 months
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Proportion who have been advised by a doctor or other health worker to be more physically active
Tidsramme: 6-9 months
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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.
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6-9 months
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Proportion of individuals overweight or obese (at baseline) who have been encouraged by a health professional to lose weight
Tidsramme: 6-9 months
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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.
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6-9 months
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Mean perceived 10-year risk of heart attack or stroke for someone of same age and sex as respondent
Tidsramme: 1-4 months
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This outcome will be measured in the baseline survey in response to information provided during the interview
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1-4 months
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Mean perceived own 10-year risk of heart attack or stroke
Tidsramme: 1-4 months
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This outcome will be measured in the baseline survey in response to information provided during the interview.
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1-4 months
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Mean perceived own 10-year risk of heart attack or stroke if were to adopt healthy lifestyle
Tidsramme: 1-4 months
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This outcome will be measured in the baseline survey in response to information provided during the interview.
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1-4 months
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General health measured by SF-36v.1
Tidsramme: 1-4 months
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Measured at baseline, this is an outcome measure not specific to CVD risk.
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1-4 months
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Labour market employment, hours and earnings
Tidsramme: 1-4 months
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Measured at baseline, this is an outcome measure not specific to CVD risk.
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1-4 months
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Health care utilization and expenditures
Tidsramme: 1-4 months
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Measured at baseline, this is an outcome measure not specific to CVD risk.
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1-4 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Joseph J Capuno, PhD, UPecon Foundation, Inc.
- Ledende efterforsker: Aleli D Kraft, PhD, UPecon Foundation, Inc.
- Ledende efterforsker: Owen O'Donnell, PhD, University of Lausanne
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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- Yusuf S, Rangarajan S, Teo K, Islam S, Li W, Liu L, Bo J, Lou Q, Lu F, Liu T, Yu L, Zhang S, Mony P, Swaminathan S, Mohan V, Gupta R, Kumar R, Vijayakumar K, Lear S, Anand S, Wielgosz A, Diaz R, Avezum A, Lopez-Jaramillo P, Lanas F, Yusoff K, Ismail N, Iqbal R, Rahman O, Rosengren A, Yusufali A, Kelishadi R, Kruger A, Puoane T, Szuba A, Chifamba J, Oguz A, McQueen M, McKee M, Dagenais G; PURE Investigators. Cardiovascular risk and events in 17 low-, middle-, and high-income countries. N Engl J Med. 2014 Aug 28;371(9):818-27. doi: 10.1056/NEJMoa1311890.
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
20. januar 2018
Primær færdiggørelse (Faktiske)
31. maj 2018
Studieafslutning (Forventet)
31. december 2021
Datoer for studieregistrering
Først indsendt
18. april 2018
Først indsendt, der opfyldte QC-kriterier
18. april 2018
Først opslået (Faktiske)
1. maj 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. april 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. april 2019
Sidst verificeret
1. april 2019
Mere information
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