The Nueva Ecija Cardiovascular Risk Experiment (NECVaRE)
2019년 4월 15일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (예상)
5019
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Quezon City, 필리핀 제도, 1101
- 모병
- UPecon Foundation
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연락하다:
- Joseph J Capuno, PhD
- 전화번호: 6329205465
- 이메일: jjcapuno@up.edu.ph
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연락하다:
- Aleli D Kraft, PhD
- 전화번호: 6329205463
- 이메일: adkraft@up.edu.ph
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
40년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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실험적: 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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간섭 없음: Control
No intervention will be introduced to the participants in this arm.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mean 10-year risk of CVD event (heart attack/stroke)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Proportion with 10-year CVD risk ≥ 10%
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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).
기간: 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
기간: 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.
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Proportion of smokers/ex-smokers who have been advised by a doctor or health worker to quit smoking
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Joseph J Capuno, PhD, UPecon Foundation, Inc.
- 수석 연구원: Aleli D Kraft, PhD, UPecon Foundation, Inc.
- 수석 연구원: Owen O'Donnell, PhD, University of Lausanne
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 1월 20일
기본 완료 (실제)
2018년 5월 31일
연구 완료 (예상)
2021년 12월 31일
연구 등록 날짜
최초 제출
2018년 4월 18일
QC 기준을 충족하는 최초 제출
2018년 4월 18일
처음 게시됨 (실제)
2018년 5월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 4월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 4월 15일
마지막으로 확인됨
2019년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- UPecon r4d
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .