- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05080517
What Are the Factors for Maintaining and Stopping of Accompanying Citizens? Do Personality Traits of Accompanying Citizens Appear to Influence These Factors? (SPICES_MIX)
In 2017, cardiovascular diseases (CVDs) were the leading cause of death worldwide. Most cardiovascular diseases can be prevented by changing risk behaviors.
CVDs are distributed within a population along a socio-economic gradient. This is true within a country, but also between countries with different income levels. People living in a high-income country have better CVD health status than those living in a low-income country.
Several studies have shown that community-based primary prevention of cardiovascular disease can be effective. Other studies have shown that champions positively influence the implementation of health promotion strategies at the community level. These champions are people in the community who contribute to the implementation of new health programs by involving their local networks.
The SPICES project (Scaling-up Packages of Intervention for Cardiovascular disease prevention in selected sites in Europe and Sub-Saharan Africa) is an international study that aims to implement and evaluate a community-based cardiovascular disease prevention and control program. It involves 5 low, middle and high income countries, including populations in urban, semi-rural and rural areas. The study focused on four sets of interventions: health promotion, cardiovascular risk profiling, management and self-management and follow-up.
In France, the territory of Central West Brittany (CWB) was chosen to participate in the SPICES project because of the vulnerability of its population to cardiovascular disease.
It is in this context that a type 1 hybrid study is being set up in the CWB territory as part of the SPICES project.
For the quantitative part of the protocol (NCT03886064), a randomized controlled trial took place simultaneously to evaluate the effectiveness of a behavior change program led by community champions. Resident volunteers were selected based on their non-laboratory Interheart score. Those with a moderate risk were included in the trial. They were then distributed at random to an intervention group and a control group. The control group received minimal counseling. Those in the intervention group were brought together in support groups, with follow-up by champions.
In a type 1 hybrid trial, qualitative data on implementation are gathered.
This qualitative study will seek understand why participants in the SPICES project staying and/or stopping, from the point of view of champions A qualitative approach using semi-structured interviews and focus groups was used. The objective is to explore maintaining and/or stopping participants in the SPICES project, from the point of view of champions
연구 개요
상태
정황
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Jean-Yves Le Reste, Dr
- 전화번호: +33 2 98 67 51 03
- 이메일: lereste@univ-brest.fr
연구 연락처 백업
- 이름: Delphine Le Goff, Dr
- 전화번호: +33 2 98 67 51 03
- 이메일: docteurdlegoff@gmail.com
연구 장소
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Lanmeur, 프랑스, 29260
- 모병
- Dr Jean-Yves Le Reste
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연락하다:
- Gabriel Perraud
- 전화번호: +33 2 98 67 51 03
- 이메일: perraudgabriel@posteo.net
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria :
- Patient over 18 years of age ;
- Have followed the training to the accompaniment proposed by the research team of SPICES ;
- Have signed the accompanying person's ethics charter co-created by the champions' research team.
Exclusion Criteria :
- Refusal of a champion to participate in the qualitative study ;
- Patients under judicial protection (guardianship, curatorship, ...).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 다른
- 시간 관점: 유망한
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Factors for maintaining or stopping
기간: Day 1
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Evaluation of the factors or maintaining or stopping of accompanying citizens through semi-directed interviews.
This is not a scale but an interview where feelings are evoked.
No score.
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Day 1
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Perceived personality traits
기간: Day 1
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Explore the correlations between the identified factors and the personality traits of the champions.
The major personality traits of the accompanying citizens will be evaluated according to the Big Five Inventory 10 questionnaire (BFI-10).
The BFI-10 is a 10-item scale measuring the Big Five personality traits Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness.
The scale was developed based on the 44-item Big Five Inventory (BFI-44; John, Donahue, & Kentle, 1991; Rammstedt, 1997) and designed for contexts in which respondents' time is severely limited.
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Day 1
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 29BRC21.0259 (SPICES_MIX)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 지원 정보 유형
- 연구 프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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