The Nueva Ecija Cardiovascular Risk Experiment (NECVaRE)
15. April 2019 aktualisiert von: 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.
Studienübersicht
Status
Unbekannt
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
5019
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Quezon City, Philippinen, 1101
- Rekrutierung
- 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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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
40 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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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Experimental: 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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Kein Eingriff: Control
No intervention will be introduced to the participants in this arm.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Mean 10-year risk of CVD event (heart attack/stroke)
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Proportion with 10-year CVD risk ≥ 10%
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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).
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Proportion of smokers/ex-smokers who have been advised by a doctor or health worker to quit smoking
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Joseph J Capuno, PhD, UPecon Foundation, Inc.
- Hauptermittler: Aleli D Kraft, PhD, UPecon Foundation, Inc.
- Hauptermittler: Owen O'Donnell, PhD, University of Lausanne
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
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Studienaufzeichnungsdaten
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Haupttermine studieren
Studienbeginn (Tatsächlich)
20. Januar 2018
Primärer Abschluss (Tatsächlich)
31. Mai 2018
Studienabschluss (Voraussichtlich)
31. Dezember 2021
Studienanmeldedaten
Zuerst eingereicht
18. April 2018
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
18. April 2018
Zuerst gepostet (Tatsächlich)
1. Mai 2018
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
17. April 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
15. April 2019
Zuletzt verifiziert
1. April 2019
Mehr Informationen
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Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- UPecon r4d
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