- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03154736
Scaling-up Packages of Interventions for Cardiovascular Disease Prevention in Selected Sites in Europe and Sub-Saharan Africa: An Implementation Research (SPICES_PHASE_1)
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
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Cardiovascular Disease
-
University of FloridaUniversity of Alabama at Birmingham; Brown UniversityCompletedCardiovascular Disease | Psychosocial Influence on Cardiovascular DiseaseUnited States
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedCardiovascular Disease | Inflammatory DiseaseUnited States
-
Morehouse School of MedicineNot yet recruiting
-
Yonsei UniversityRecruitingCardiovascular DiseaseKorea, Republic of
-
Nanjing Medical UniversityNot yet recruitingCardiovascular Disease
-
National Human Genome Research Institute (NHGRI)Active, not recruiting
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruiting
-
AmgenCompletedCardiovascular DiseaseUnited States, Australia
-
VA Office of Research and DevelopmentEnrolling by invitationCardiovascular DiseaseUnited States
Clinical Trials on Interview
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); National Institute on Alcohol Abuse... and other collaboratorsCompleted
-
Centro Hospitalar Lisboa NorteUniversity of Lisbon; Faculdade de Psicologia e de Ciências de Educação da...Unknown
-
Ohio UniversityNew York Blood CenterCompleted
-
University of New MexicoCompletedPregnancy TerminationUnited States
-
Wayne State UniversityBlue Cross Blue Shield of Michigan FoundationCompleted
-
Assistance Publique - Hôpitaux de ParisNational Cancer Institute, FranceCompletedCancer | Elderly | Ethnographic Interview | Social Representation of Being Aged | Reasons of Non-participation in Clinical Trials | Qualitative MethodFrance
-
Dongzhimen Hospital, BeijingUnknown
-
Beth Israel Deaconess Medical CenterCompletedDyspepsia | Heartburn | Gastroesophageal Reflux Disease (GERD)United States
-
University of Eastern FinlandCompleted
-
University Hospital, GrenobleRegional Council of Auvergne-Rhône-AlpesRecruitingTraumatic Brain InjuryFrance