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

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Risk Factor

• Study Type: Observational
• Enrollment (Anticipated): 21

Contacts and Locations

• Study Contact: Name: Jean-Yves Le Reste, Dr; Phone Number: +33 2 98 67 51 03; Email: lereste@univ-brest.fr
• Study Contact Backup: Name: Delphine Le Goff, Dr; Phone Number: +33 2 98 67 51 03; Email: docteurdlegoff@gmail.com

Study Locations

• France
  • Lanmeur, France, 29260
    • Recruiting
    • Dr Jean-Yves Le Reste
    • Contact: Gabriel Perraud; Phone Number: +33 2 98 67 51 03; Email: perraudgabriel@posteo.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The champions recruited in the SPICES study.

Description

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, ...).

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: September 30, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 29BRC21.0259 (SPICES_MIX)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning five years and ending fifteen years following the final study report completion.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No