What Are the Factors for Maintaining and Stopping of Accompanying Citizens? Do Personality Traits of Accompanying Citizens Appear to Influence These Factors?

Cardiovascular Risk Factor Clinical Trial

— SPICES_MIX  

Official title:

What Are the Factors for Maintaining and Stopping of Accompanying Citizens? Do Personality Traits of Accompanying Citizens Appear to Influence These Factors?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05080517
• Other study ID #: 29BRC21.0259 (SPICES_MIX)
• Status: Recruiting
• Start date: November 1, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: October 2021
• Source: University Hospital, Brest
• Contact: Jean-Yves Le Reste, Dr
• Phone: 2 98 67 51 03
• Email: lereste[@]univ-brest.fr
• 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• 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 Jean-Yves 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	Factors for maintaining or stopping	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.	Day 1
Secondary	Perceived personality traits	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.	Day 1