Scaling-up Packages of Interventions for Cardiovascular Disease Prevention in Selected Sites in Europe and Sub-Saharan Africa: An Implementation Research (SPICES_PHASE_1)

April 3, 2019 updated by: University Hospital, Brest

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Carhaix Plouguer, France
        • Carhaix Plouguer
      • Chateauneuf du Faou, France
        • Chateauneuf du Faou
      • Coray, France
        • Coray
      • Guiscriff, France
        • Guiscriff
      • Guémené-sur-Scorff, France
        • Guémené-sur-Scorff
      • La Chapelle Thouarault, France
        • La Chapelle Thouarault
      • Landeleau, France
        • Landeleau
      • Laniscat, France, 22570
        • Laniscat
      • Laz, France
        • LAZ
      • Le Faouët, France
        • Le Faouet
      • Nevez, France
        • Nevez
      • Plonévez-du-Faou, France
        • Plonévez du Faou
      • Plounevez-Quintin, France
        • Plounevez-Quintin
      • Plouray, France, 56770
        • Plouray
      • Poullaouen, France
        • Poullaouen
      • Rostrenen, France
        • Rostrenen
      • Roudouallec, France
        • Roudouallec
      • Saint-Nicolas-du-Pélem, France
        • Saint Nicolas du Pelem
      • Spezet, France
        • Spezet
      • Trégourez, France
        • Tregourez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Interview
Individual interview an in a group interview. Socio-economic questionnaire
Individual interview and group interview Socio-economic questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Experiences of patients with cardiovascular disease
Time Frame: 1 day
The representations on cardiovascular prevention and the follow-up experience of patients with cardiovascular disease or CVRF will be defined by questionnaire
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The obstacles of patients with cardiovascular disease
Time Frame: 1 day
The obstacles to the management of patients with CVD or CVRF will be identified by questionnaire
1 day
Institutional care network
Time Frame: 1 day
The institutional care network for these patients will be identified by questionnaire
1 day
Informal or informal care network
Time Frame: 1 day
The "informal" care network, that is to say, family or community caregivers and within them the brakes and facilitators will be identified by questionnaire
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 2, 2017

Primary Completion (ACTUAL)

February 28, 2019

Study Completion (ACTUAL)

February 28, 2019

Study Registration Dates

First Submitted

May 11, 2017

First Submitted That Met QC Criteria

May 15, 2017

First Posted (ACTUAL)

May 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC17.0015 SPICES_PHASE_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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