Scaling-up Packages of Interventions for Cardiovascular Disease Prevention in Selected Sites in Europe and Sub-Saharan Africa: An Implementation Research
SPICES_PHASE_1
1 other identifier
interventional
56
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2017
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2017
CompletedFirst Posted
Study publicly available on registry
May 16, 2017
CompletedStudy Start
First participant enrolled
October 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2019
CompletedApril 4, 2019
April 1, 2019
1.4 years
May 11, 2017
April 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Experiences of patients with cardiovascular disease
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 Outcomes (3)
The obstacles of patients with cardiovascular disease
1 day
Institutional care network
1 day
Informal or informal care network
1 day
Study Arms (1)
Interview
EXPERIMENTALIndividual interview an in a group interview. Socio-economic questionnaire
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Brestlead
- ERCR SPURBOcollaborator
Study Sites (21)
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, 22570, 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, 56770, 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
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2017
First Posted
May 16, 2017
Study Start
October 2, 2017
Primary Completion
February 28, 2019
Study Completion
February 28, 2019
Last Updated
April 4, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share