The Nueva Ecija Cardiovascular Risk Experiment (NECVaRE)
2019年4月15日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (予想される)
5019
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Joseph J Capuno, PhD
- 電話番号：6329205465
- メール：jjcapuno@up.edu.ph
研究連絡先のバックアップ
- 名前：Aleli D Kraft, PhD
- 電話番号：6329205463
- メール：adkraft@up.edu.ph
研究場所
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Quezon City、フィリピン、1101
- 募集
- UPecon Foundation
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コンタクト：
- Joseph J Capuno, PhD
- 電話番号：6329205465
- メール：jjcapuno@up.edu.ph
-
コンタクト：
- Aleli D Kraft, PhD
- 電話番号：6329205463
- メール：adkraft@up.edu.ph
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
40年～70年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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実験的：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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介入なし：Control
No intervention will be introduced to the participants in this arm.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mean 10-year risk of CVD event (heart attack/stroke)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Proportion with 10-year CVD risk ≥ 10%
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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).
時間枠：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
時間枠：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.
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of smokers/ex-smokers who have been advised by a doctor or health worker to quit smoking
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Joseph J Capuno, PhD、UPecon Foundation, Inc.
- 主任研究者：Aleli D Kraft, PhD、UPecon Foundation, Inc.
- 主任研究者：Owen O'Donnell, PhD、University of Lausanne
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年1月20日
一次修了 (実際)
2018年5月31日
研究の完了 (予想される)
2021年12月31日
試験登録日
最初に提出
2018年4月18日
QC基準を満たした最初の提出物
2018年4月18日
最初の投稿 (実際)
2018年5月1日
学習記録の更新
投稿された最後の更新 (実際)
2019年4月17日
QC基準を満たした最後の更新が送信されました
2019年4月15日
最終確認日
2019年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- UPecon r4d
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
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