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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05080517
Recruitment Status : Recruiting
First Posted : October 15, 2021
Last Update Posted : October 15, 2021
Information provided by (Responsible Party):
University Hospital, Brest

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.

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

Condition or disease
Cardiovascular Risk Factor

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Study Type : Observational
Estimated Enrollment : 21 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: What Are the Factors for Maintaining and Stopping of Accompanying Citizens? Do Personality Traits of Accompanying Citizens Appear to Influence These Factors?
Estimated Study Start Date : November 1, 2021
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : November 1, 2022

Primary Outcome Measures :
  1. Factors for maintaining or stopping [ Time Frame: Day 1 ]
    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.

Secondary Outcome Measures :
  1. Perceived personality traits [ Time Frame: Day 1 ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The champions recruited in the SPICES study.

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, ...).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05080517

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Contact: Jean-Yves Le Reste, Dr 2 98 67 51 03 ext +33
Contact: Delphine Le Goff, Dr 2 98 67 51 03 ext +33

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Dr Jean-Yves Le Reste Recruiting
Lanmeur, France, 29260
Contact: Gabriel Perraud    2 98 67 51 03 ext +33   
Sponsors and Collaborators
University Hospital, Brest
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Responsible Party: University Hospital, Brest Identifier: NCT05080517    
Other Study ID Numbers: 29BRC21.0259 (SPICES_MIX)
First Posted: October 15, 2021    Key Record Dates
Last Update Posted: October 15, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication
Supporting Materials: Study Protocol
Time Frame: Data will be available beginning five years and ending fifteen years following the final study report completion.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No