Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-28 @ 12:58 PM
Study NCT ID:
NCT04749550
Status:
COMPLETED
Last Update Posted:
2021-02-11
First Post:
2021-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community Champions Included in the SPICES Project: Study of Facilitators and Barriers to Their Participation in Support Groups for the Primary Prevention of Cardiovascular Risk Factors: (EFFPCA)
Sponsor:
University Hospital, Brest
Organization:
Study Overview
Official Title:
Community Champions Included in the SPICES Project: Study of Facilitators and Barriers to Their Participation in Support Groups for the Primary Prevention of Cardiovascular Risk Factors: A Qualitative Study in Grounded Theory by Semi-structured Interviews and Focus Groups
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
The qualitative study will seek to better understand the profile of these champions. A qualitative approach using semi-structured interviews and focus groups was used. The objective is to explore the barriers and facilitators to their participation in support groups for the primary prevention of modifiable cardiovascular risk factors.
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.
The qualitative study will seek to better understand the profile of these champions. A qualitative approach using semi-structured interviews and focus groups was used. The objective is to explore the barriers and facilitators to their participation in support groups for the primary prevention of modifiable cardiovascular risk factors.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: