The Nueva Ecija Cardiovascular Risk Experiment (NECVaRE)
15. dubna 2019 aktualizováno: 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.
Přehled studie
Postavení
Neznámý
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Očekávaný)
5019
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Joseph J Capuno, PhD
- Telefonní číslo: 6329205465
- E-mail: jjcapuno@up.edu.ph
Studijní záloha kontaktů
- Jméno: Aleli D Kraft, PhD
- Telefonní číslo: 6329205463
- E-mail: adkraft@up.edu.ph
Studijní místa
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Quezon City, Filipíny, 1101
- Nábor
- UPecon Foundation
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Kontakt:
- Joseph J Capuno, PhD
- Telefonní číslo: 6329205465
- E-mail: jjcapuno@up.edu.ph
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Kontakt:
- Aleli D Kraft, PhD
- Telefonní číslo: 6329205463
- E-mail: adkraft@up.edu.ph
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
40 let až 70 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Experimentální: 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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Žádný zásah: Control
No intervention will be introduced to the participants in this arm.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Mean 10-year risk of CVD event (heart attack/stroke)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Proportion with 10-year CVD risk ≥ 10%
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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).
Časové okno: 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
Časové okno: 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.
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Proportion of smokers/ex-smokers who have been advised by a doctor or health worker to quit smoking
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Joseph J Capuno, PhD, UPecon Foundation, Inc.
- Vrchní vyšetřovatel: Aleli D Kraft, PhD, UPecon Foundation, Inc.
- Vrchní vyšetřovatel: Owen O'Donnell, PhD, University of Lausanne
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
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- 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.
- Yikona JI, Wallis EJ, Ramsay LE, Jackson PR. Coronary and cardiovascular risk estimation in uncomplicated mild hypertension. A comparison of risk assessment methods. J Hypertens. 2002 Nov;20(11):2173-82. doi: 10.1097/00004872-200211000-00016.
- 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.
- 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]
- Capuno J, Kraft A, O'Donnell O. Effectiveness of clinic-based cardiovascular disease prevention: A randomized encouragement design experiment in the Philippines. Soc Sci Med. 2021 Aug;283:114194. doi: 10.1016/j.socscimed.2021.114194. Epub 2021 Jul 3.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
20. ledna 2018
Primární dokončení (Aktuální)
31. května 2018
Dokončení studie (Očekávaný)
31. prosince 2021
Termíny zápisu do studia
První předloženo
18. dubna 2018
První předloženo, které splnilo kritéria kontroly kvality
18. dubna 2018
První zveřejněno (Aktuální)
1. května 2018
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
17. dubna 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
15. dubna 2019
Naposledy ověřeno
1. dubna 2019
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- UPecon r4d
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Nerozhodný
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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