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)

Cardiovascular Risk Factor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04749550
• Other study ID #: 29BRC20.0271 (SPICES_EFFPCA)
• Status: Completed
• Start date: March 16, 2020
• Est. completion date: June 25, 2020

Study information

• Verified date: February 2021
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 25, 2020
• Est. primary completion date: June 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, ...).

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Locations

Country	Name	City	State
France	Dr Le Reste	Lanmeur

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived barriers and facilitators	List and connections between barriers and facilitators affecting participation of citizen of volunteers as champions in SPICES coaching groups by individual interviews. It is not a scale but in interview where feelings are raised. No score.	Day 1
Secondary	Perceived common personality traits	List and connexion of common personality traits among community champions participating in the SPICES project during focus group. It is not a scale but in grouped interview where feelings are raised. No score.	Day 1