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The Nueva Ecija Cardiovascular Risk Experiment (NECVaRE)

15 kwietnia 2019 zaktualizowane przez: 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.

Przegląd badań

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Oczekiwany)

5019

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

      • Quezon City, Filipiny, 1101
        • Rekrutacyjny
        • UPecon Foundation
        • Kontakt:
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

40 lat do 70 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
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.
Eksperymentalny: 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.
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.
Brak interwencji: Control
No intervention will be introduced to the participants in this arm.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Mean 10-year risk of CVD event (heart attack/stroke)
Ramy czasowe: 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.
6-9 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Proportion with 10-year CVD risk ≥ 10%
Ramy czasowe: 6-9 months
Predicted risk obtained from Globorisk as for primary outcome. If power permits, will also estimate effects on proportion with CVD risk>20% and >30%.
6-9 months
Mean systolic blood pressure (SBP)
Ramy czasowe: 6-9 months
Predicted CVD risk is function of blood pressure, BMI and smoking. We will also estimate effects on these risk factors separately. Mean of last two SBP measures on single visit. BP measured using electronic (OMRON) wrap cuff monitor.
6-9 months
Proportion with elevated blood pressure (systolic ≥140)
Ramy czasowe: 6-9 months
Predicted CVD risk is function of blood pressure, BMI and smoking. We will also estimate effects on these risk factors separately. Mean of last two SBP measures on single visit. BP measured using electronic (OMRON) wrap cuff monitor.
6-9 months
Mean BMI
Ramy czasowe: 6-9 months
Predicted CVD risk is function of blood pressure, BMI and smoking. We will also estimate effects on these risk factors separately. Height and weight measured using standardized instruments.
6-9 months
Proportion overweight/obese (BMI>25)
Ramy czasowe: 6-9 months
Predicted CVD risk is function of blood pressure, BMI and smoking. We will also estimate effects on these risk factors separately. Height and weight measured using standardized instruments.
6-9 months
Proportion currently smoking
Ramy czasowe: 6-9 months
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
Ramy czasowe: 6-9 months
Globorisk predicted 10-year CVD risk is not a function of central adiposity, but this is measured as part of PhilPEN risk assessment. Weight circumference will be measured followed a standardized procedure.
6-9 months
Proportion with waist circumference ≥ 90cm (men) / 80cm (women).
Ramy czasowe: 6-9 months
Globorisk predicted 10-year CVD risk is not a function of central adiposity, but this is measured as part of PhilPEN risk assessment. Weight circumference will be measured followed a standardized procedure.
6-9 months
Proportion with undiagnosed hypertension
Ramy czasowe: 6-9 months
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.
Ramy czasowe: 6-9 months
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
Ramy czasowe: 6-9 months
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)
Ramy czasowe: 6-9 months
A measure of health behavior consistent with those of WHO STEPS.
6-9 months
Exercise
Ramy czasowe: 6-9 months
A measure of health behavior consistent with those of WHO STEPS.
6-9 months
Knowledge of CVD and diabetes risk factors
Ramy czasowe: 6-9 months
Knowledge of CVD and diabetes risk factors assessed using questions adapted from previously fielded instruments.
6-9 months

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Proportion of smokers/ex-smokers who have been advised by a doctor or health worker to quit smoking
Ramy czasowe: 6-9 months
For the lottery intervention, we will examine whether attending a health clinic for a checkup increases the probability of receiving medical advice on the adoption of healthier habits, as is prescribed by the PhilPEN protocol.
6-9 months
Proportion of smokers/ex-smokers who have received counselling on smoking cessation
Ramy czasowe: 6-9 months
For the lottery intervention, we will examine whether attending a health clinic for a checkup increases the probability of receiving medical advice on the adoption of healthier habits, as is prescribed by the PhilPEN protocol.
6-9 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)
Ramy czasowe: 6-9 months
For the lottery intervention, we will examine whether attending a health clinic for a checkup increases the probability of receiving medical advice on the adoption of healthier habits, as is prescribed by the PhilPEN protocol.
6-9 months
Proportion who have been advised by a doctor or other health worker to eat less salty and/or fatty food
Ramy czasowe: 6-9 months
For the lottery intervention, we will examine whether attending a health clinic for a checkup increases the probability of receiving medical advice on the adoption of healthier habits, as is prescribed by the PhilPEN protocol.
6-9 months
Proportion who have been advised by a doctor or other health worker to eat more fruit and vegetables and/or grains and pulses
Ramy czasowe: 6-9 months
For the lottery intervention, we will examine whether attending a health clinic for a checkup increases the probability of receiving medical advice on the adoption of healthier habits, as is prescribed by the PhilPEN protocol.
6-9 months
Proportion who have been advised by a doctor or other health worker to be more physically active
Ramy czasowe: 6-9 months
For the lottery intervention, we will examine whether attending a health clinic for a checkup increases the probability of receiving medical advice on the adoption of healthier habits, as is prescribed by the PhilPEN protocol.
6-9 months
Proportion of individuals overweight or obese (at baseline) who have been encouraged by a health professional to lose weight
Ramy czasowe: 6-9 months
For the lottery intervention, we will examine whether attending a health clinic for a checkup increases the probability of receiving medical advice on the adoption of healthier habits, as is prescribed by the PhilPEN protocol.
6-9 months
Mean perceived 10-year risk of heart attack or stroke for someone of same age and sex as respondent
Ramy czasowe: 1-4 months
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
Ramy czasowe: 1-4 months
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
Ramy czasowe: 1-4 months
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
Ramy czasowe: 1-4 months
Measured at baseline, this is an outcome measure not specific to CVD risk.
1-4 months
Labour market employment, hours and earnings
Ramy czasowe: 1-4 months
Measured at baseline, this is an outcome measure not specific to CVD risk.
1-4 months
Health care utilization and expenditures
Ramy czasowe: 1-4 months
Measured at baseline, this is an outcome measure not specific to CVD risk.
1-4 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Współpracownicy

Śledczy

  • Główny śledczy: Joseph J Capuno, PhD, UPecon Foundation, Inc.
  • Główny śledczy: Aleli D Kraft, PhD, UPecon Foundation, Inc.
  • Główny śledczy: Owen O'Donnell, PhD, University of Lausanne

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

20 stycznia 2018

Zakończenie podstawowe (Rzeczywisty)

31 maja 2018

Ukończenie studiów (Oczekiwany)

31 grudnia 2021

Daty rejestracji na studia

Pierwszy przesłany

18 kwietnia 2018

Pierwszy przesłany, który spełnia kryteria kontroli jakości

18 kwietnia 2018

Pierwszy wysłany (Rzeczywisty)

1 maja 2018

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

17 kwietnia 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

15 kwietnia 2019

Ostatnia weryfikacja

1 kwietnia 2019

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • UPecon r4d

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

Niezdecydowany

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

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