NCT03154736

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

October 2, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

1.4 years

First QC Date

May 11, 2017

Last Update Submit

April 3, 2019

Conditions

Keywords

CVDFDRCVDeveloping countriesRcih countries

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

EXPERIMENTAL

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

Other: Interview

Interventions

Individual interview and group interview Socio-economic questionnaire

Interview

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (21)

Carhaix Plouguer

Carhaix-Plouguer, France

Location

Chateauneuf du Faou

Châteauneuf-du-Faou, France

Location

Coray

Coray, France

Location

Guémené-sur-Scorff

Guémené-sur-Scorff, France

Location

Guiscriff

Guiscriff, France

Location

La Chapelle Thouarault

La Chapelle-Thouarault, France

Location

Landeleau

Landeleau, France

Location

Laniscat

Laniscat, 22570, France

Location

LAZ

Laz, France

Location

Le Faouet

Le Faouët, France

Location

Nevez

Névez, France

Location

Plonevez du faou

Plonévez-du-Faou, France

Location

Plonévez du Faou

Plonévez-du-Faou, France

Location

Plounevez-Quintin

Plounévez-Quintin, France

Location

Plouray

Plouray, 56770, France

Location

Poullaouen

Poullaouen, France

Location

Rostrenen

Rostrenen, France

Location

Roudouallec

Roudouallec, France

Location

Saint Nicolas du Pelem

Saint-Nicolas-du-Pélem, France

Location

Spezet

Spézet, France

Location

Tregourez

Trégourez, France

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

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

Locations