The Nueva Ecija Cardiovascular Risk Experiment

NCT03512691 | Unknown

• 1 other identifier: UPecon r4d
• Study Type: interventional
• Target: 5,019
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Diseases; Cardiovascular Risk Factor

Keywords

Risk perceptions and attitudes, time preference, information

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (14)

• Proportion with 10-year CVD risk ≥ 10%

  6-9 months

• Mean systolic blood pressure (SBP)

  6-9 months

• Proportion with elevated blood pressure (systolic ≥140)

  6-9 months

• Mean BMI

  6-9 months

• Proportion overweight/obese (BMI>25)

  6-9 months

Other Outcomes (13)

• Proportion of smokers/ex-smokers who have been advised by a doctor or health worker to quit smoking

  6-9 months

• Proportion of smokers/ex-smokers who have received counselling on smoking cessation

  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)

  6-9 months

Study Arms (3)

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.

Behavioral: Information on CVD Risk

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.

Behavioral: Lottery Incentive

Control

NO INTERVENTION

No intervention will be introduced to the participants in this arm.

Interventions

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.

Information on CVD risk

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.

Lottery Incentive

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UPecon Foundation, Inc.: lead
• University of Lausanne: collaborator

Study Sites (1)

UPecon Foundation

Quezon City, 1101, Philippines

RECRUITING

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  PMID: 34274784 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Behavior

Study Officials

• Joseph J Capuno, PhD

  UPecon Foundation, Inc.

  PRINCIPAL INVESTIGATOR

• Aleli D Kraft, PhD

  UPecon Foundation, Inc.

  PRINCIPAL INVESTIGATOR

• Owen O'Donnell, PhD

  University of Lausanne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph J Capuno, PhD

CONTACT

6329205465; jjcapuno@up.edu.ph

Aleli D Kraft, PhD

CONTACT

6329205463; adkraft@up.edu.ph

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: May 1, 2018
• Study Start: January 20, 2018
• Primary Completion: May 31, 2018
• Study Completion: December 31, 2021
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

PH (1)