Scaling-up Packages of Interventions for Cardiovascular Disease Prevention in Selected Sites in Europe and Sub-Saharan Africa: An Implementation Research

NCT ID: NCT03154736

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-02
• Study Completion Date: 2019-02-28

Brief Summary

Cardiovascular disease is the leading cause of death in the world. 17.5 million people died in 2012 due to a cerebrovascular disease (31% of all causes of death). In Europe more than 50% of deaths are due to cardiovascular disease. The mortality rate for cardiovascular disease is higher in the lower socio-economic levels. Three-quarters of deaths from cardiovascular disease occur in developing countries. According to estimates in 2030, cardiovascular disease will be responsible for more deaths than the sum of infectious, nutritional, maternal and perinatal diseases in developing countries.

Measures to prevent cardiovascular risk factors have been shown to be effective.

The lack of an adequate primary care network in developing countries limits the screening and treatment of patients with cardiovascular risk factors. As a result, these patients do not benefit from adequate prevention, are diagnosed late and remain disabled or die at a young age, resulting in significant additional costs for families but also at the macroeconomic level.

Interventions are possible on a large scale (policies against tobacco and adverse dietary behavior, promote physical activity, etc.). Actions are possible on an individual level, both in primary prevention (control of cardiovascular risk factors) and secondary prevention, where many treatments have proved their effectiveness. These interventions are effective and cost-effective from a macroeconomic perspective. It was estimated that the cost of such interventions would not exceed 4% of health expenditure in developing countries and 1-2% in rich countries.

The World Health Organization insists on the importance of the triad composed by the patient and his family, community and health professionals. Results are possible only when these three components work together for the same purpose. Numerous studies show the benefit of the involvement of patients in their care in the rich countries and in the developing countries.

Detailed Description

This project builds on advances in the treatment of HIV / AIDS in Sub-Saharan Africa and in chronic disease management through the WHO Innovative Care for Chronic Conditions Framework.

These projects emerged from the observation that the rich country model of care (patient-centered, hospital-centered and specialist approach with regular clinical and paraclinic follow-up) was not transferable to developing countries, The limitation of human, technical and financial resources.

A paradigm shift is needed to improve cardiovascular disease control in a more cost-effective manner.

The SPICES project plans to integrate the current knowledge of new studies to improve the prevention and control of cardiovascular disease in high-, middle-, and low-income countries.

Rich countries and developing countries will therefore be involved in the study: the selected sites are France, the United Kingdom, Belgium, South Africa and Uganda.

This study is a stage of observation in the different countries which will make it possible to make an inventory of the places and to target the most adapted interventions.

The main objective is to define the representations on cardiovascular prevention and the follow up of patients with cardiovascular disease or FDRCV.

The secondary objectives are to identify:

• the brakes in the management of patients with CVD or FDRCV
• the institutional care network for these patients
• Identify the "informal" care network, that is, family and community caregivers and within them the potential barriers and facilitators to their care.

Conditions

Cardiovascular Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Interview

Individual interview an in a group interview. Socio-economic questionnaire

Group Type: EXPERIMENTAL

Interview

Intervention Type: OTHER

Individual interview and group interview Socio-economic questionnaire

Interventions

Interview

Individual interview and group interview Socio-economic questionnaire

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Persons aged over 18 years.
• Persons able to express their consent
• Patients with FDRCV or CVD who gave written consent to participate in the study.
• Family caregiver of patients with FDRCV or CVD with written consent to participate in the study

Exclusion Criteria

• Refusal to participate in the study
• Patients and / or family caregiver who can not express their consent (illiterate, severe cognitive or psychiatric disorders)
• Patients under judicial protection (guardianship and curatorship)
• Pregnant women
• Patients under 18 years of age

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ERCR SPURBO

OTHER

Sponsor Role: collaborator

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Carhaix Plouguer

Carhaix-Plouguer, , France

Chateauneuf du Faou

Châteauneuf-du-Faou, , France

Coray

Coray, , France

Guémené-sur-Scorff

Guémené-sur-Scorff, , France

Guiscriff

Guiscriff, , France

La Chapelle Thouarault

La Chapelle-Thouarault, , France

Landeleau

Landeleau, , France

Laniscat

Laniscat, , France

LAZ

Laz, , France

Le Faouet

Le Faouët, , France

Nevez

Névez, , France

Plonevez du faou

Plonévez-du-Faou, , France

Plonévez du Faou

Plonévez-du-Faou, , France

Plounevez-Quintin

Plounévez-Quintin, , France

Plouray

Plouray, , France

Poullaouen

Poullaouen, , France

Rostrenen

Rostrenen, , France

Roudouallec

Roudouallec, , France

Saint Nicolas du Pelem

Saint-Nicolas-du-Pélem, , France

Spezet

Spézet, , France

Tregourez

Trégourez, , France

Countries

France

Other Identifiers

29BRC17.0015 SPICES_PHASE_1

Identifier Type: -

Identifier Source: org_study_id