Clinical trial NCT03154736: Scaling-up Packages of Interventions for Cardiovascular Disease Prevention in Selected Sites in Europe and Sub-Saharan Africa: An Implementation Research
Official title: Scaling-up Packages of Interventions for Cardiovascular Disease Prevention in Selected Sites in Europe and Sub-Saharan Africa: An Implementation Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: CVD
FDRCV
Developing countries
Rcih countries
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: ERCR SPURBO
First posted: 2017-05-16
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Experiences of patients with cardiovascular disease
timeFrame: 1 day
Secondary outcomes:
measure: The obstacles of patients with cardiovascular disease
timeFrame: 1 day
measure: Institutional care network
timeFrame: 1 day
measure: Informal or informal care network
timeFrame: 1 day
Other outcomes:
Locations:
city: Carhaix Plouguer
country: France
facility: Carhaix Plouguer
city: Chateauneuf du Faou
country: France
facility: Chateauneuf du Faou
city: Coray
country: France
facility: Coray
city: Guiscriff
country: France
facility: Guiscriff
city: Guémené-sur-Scorff
country: France
facility: Guémené-sur-Scorff
city: La Chapelle Thouarault
country: France
facility: La Chapelle Thouarault
city: Landeleau
country: France
facility: Landeleau
city: Laniscat
country: France
facility: Laniscat
city: Laz
country: France
facility: LAZ
city: Le Faouët
country: France
facility: Le Faouet
city: Nevez
country: France
facility: Nevez
city: Plonévez-du-Faou
country: France
facility: Plonevez du faou
city: Plonévez-du-Faou
country: France
facility: Plonévez du Faou
city: Plounevez-Quintin
country: France
facility: Plounevez-Quintin
city: Plouray
country: France
facility: Plouray
city: Poullaouen
country: France
facility: Poullaouen
city: Rostrenen
country: France
facility: Rostrenen
city: Roudouallec
country: France
facility: Roudouallec
city: Saint-Nicolas-du-Pélem
country: France
facility: Saint Nicolas du Pelem
city: Spezet
country: France
facility: Spezet
city: Trégourez
country: France
facility: Tregourez
Study officials:
References: