Cardiovascular DiseaseSPICES_PHASE_1NCT03154736
Scaling-up Packages of Interventions for Cardiovascular Disease Prevention in Selected Sites in Europe and Sub-Saharan Africa: An Implementation Research
A study testing Interview in people with Cardiovascular Disease, run by University Hospital, Brest at 21 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 21 sitesFrance
- Study dates
- 2 Oct 2017to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites
Carhaix Plouguer
Carhaix-Plouguer
Chateauneuf du Faou
Châteauneuf-du-Faou
Coray
Coray
Guémené-sur-Scorff
Guémené-sur-Scorff
Guiscriff
Guiscriff
La Chapelle Thouarault
La Chapelle-Thouarault
Landeleau
Landeleau
Laniscat
Laniscat, 22570
LAZ
Laz
Le Faouet
Le Faouët
Nevez
Névez
Plonevez du faou
Plonévez-du-Faou
Plonévez du Faou
Plonévez-du-Faou
Plounevez-Quintin
Plounévez-Quintin
Plouray
Plouray, 56770
Poullaouen
Poullaouen
Rostrenen
Rostrenen
Roudouallec
Roudouallec
Saint Nicolas du Pelem
Saint-Nicolas-du-Pélem
Spezet
Spézet
Tregourez
Trégourez
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- Interview
- Keywords
- CVD, FDRCV, Developing countries, Rcih countries
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Individual interview and group interview Socio-economic questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Interview | Experimental | Individual interview an in a group interview. Socio-economic questionnaire Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (3)
The obstacles of patients with cardiovascular disease
The obstacles to the management of patients with CVD or CVRF will be identified by questionnaire
Measured: 1 day
Institutional care network
The institutional care network for these patients will be identified by questionnaire
Measured: 1 day
Informal or informal care network
The "informal" care network, that is to say, family or community caregivers and within them the brakes and facilitators will be identified by questionnaire
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start2 Oct 2017
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- ERCR SPURBO
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154736
- Sponsor's protocol ID
- 29BRC17.0015 SPICES_PHASE_1
- Acronym
- SPICES_PHASE_1
- Status last verified
- Apr 2019
- First submitted
- 11 May 2017
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling-up Packages of Interventions for Cardiovascular Disease Prevention in Selected Sites in Europe and Sub-Saharan Africa: An Implementation Research
- ClinicalTrials.gov ID
- NCT03154736
- Acronym / sponsor ID
- SPICES_PHASE_1 / 29BRC17.0015 SPICES_PHASE_1
- Conditions
- Cardiovascular Disease
- Keywords
- CVD, FDRCV, Developing countries, Rcih countries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- ERCR SPURBO
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 16 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interview | Experimental | Other: InterviewIndividual interview an in a group interview. Socio-economic questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewIndividual interview and group interview Socio-economic questionnaire | Other | Interview |
Primary outcome
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
3 secondary outcomes
The obstacles of patients with cardiovascular disease
Time frame: 1 day
Institutional care network
Time frame: 1 day
Informal or informal care network
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interview in people with Cardiovascular Disease, run by University Hospital, Brest at 21 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experiences of patients with cardiovascular disease (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.