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Clinical Trials/NCT05080517
NCT05080517
Unknown
Not Applicable

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

University Hospital, Brest1 site in 1 country21 target enrollmentNovember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Risk Factor
Sponsor
University Hospital, Brest
Enrollment
21
Locations
1
Primary Endpoint
Factors for maintaining or stopping
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
November 1, 2021
End Date
November 1, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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 Outcomes

  • Perceived personality traits(Day 1)

Study Sites (1)

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