Cardiovascular Risk FactorsSpices_phase_2NCT03886064
Cardiovascular Disease Prevention in Europe and Sub-Saharan Africa
A study testing Multi-behavioral intervention in people with Cardiovascular Risk Factors, run by University Hospital, Brest at 2 sites in France.
Trial summary
Cardiovascular disease (CVD) is the leading cause of death in the world. 17.5 million people died in 2012 due to CVD (31% of all causes of death). In Europe more than 50% of deaths are due to CVD. The CVD mortality rate is higher in the lower socio-economic levels. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiovascular Risk Factors
- What is being tested?
- Multi-behavioral intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 583 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Apr 2019to 5 Jan 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Within the general population, all persons over 18 years of age living or working in the country Center Bretagne (including Pays Pays Ouest Bretagne, Pleyben and Callac) with a moderate cardiovascular risk score based on the Interheart clinical risk score (score 9-15).
Who cannot join
- Pregnancy
- Age under 18 years old
- Patient in secondary cardiovascular prevention
- Nobody living or working in Central Brittany (Pays Center Ouest Bretagne and Pays de Pleyben and Callac)
- Low (<9) or high cardiovascular risk score by Interheart score (> 15).
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Scaling-up Packages of Interventions for Cardiovascular Disease Prevention in Selected Sites in Europe and Sub-Saharan Africa. SPICES Study Implementation Phase
Cardiovascular disease (CVD) is the leading cause of death in the world. 17.5 million people died in 2012 due to CVD (31% of all causes of death). In Europe more than 50% of deaths are due to CVD. The CVD mortality rate is higher in the lower socio-economic levels. Three quarters of CVD deaths occur in developing countries (LDCs). According to estimates in 2030, CVD will be responsible for more deaths than the sum of infectious, nutritional, maternal and perinatal diseases in developing countries. The lack of an adequate primary care network in developing countries limits the screening and treatment of people with CVRF. As a result, these people do not benefit from appropriate 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.
Cardiovascular risk factor prevention measures (CVRF) have been shown to be effective. Interventions are possible on a large scale (policies against smoking and unfavorable eating habits, promoting physical activity, etc.). Actions are possible at the individual level, both in primary prevention (fight against the FDRCV) and secondary, where many treatments have proven their effectiveness. These interventions are effective and profitable from a macroeconomic point of view. It has been estimated that the cost for such interventions would not exceed 4% of health expenditure in developing countries and 1-2% in rich countries.
Read more
The World Health Organization (WHO) stresses the importance of the triad composed by the patient and his family, the community and health professionals. Results are possible only when these three components work together for the same purpose. Many studies show the benefit of people's involvement in care in rich and developing countries.
SPICES project builds on progress in HIV / AIDS treatment in sub-Saharan Africa (SSA) and chronic disease management through the Innovative Care for Chronic Conditions (ICCC Framework), WHO plan. With regard to HIV treatment, these interventions have proven to be effective and cost-effective in many SSA countries, both in terms of disease control and adherence. These data on communicable and infectious diseases seem to be transferable to non-communicable diseases.
These projects were born from the observation that the model of care of the rich countries (individual approach of the patient, centered on the hospital and the specialist with a regular clinical and paraclinical follow-up) could not be transposed to the developing countries, because the limitation of human, technical and financial resources. But also that this model was becoming more and more difficult to maintain in developed countries or resources become limited. New approaches need to be developed to increase the effectiveness of health systems.
A paradigm shift is needed to improve the control of CVD with greater cost-effectiveness.
The SPICES project incorporates the most up-to-date knowledge to improve the prevention and control of CVD in high-, middle- and low-income countries.
Rich countries and developing countries are therefore involved in the study. The selected sites are France, United Kingdom, Belgium, South Africa and Uganda.
Some main axes of the ICCC Framework will be developed in SPICES:
- improve the efficiency of health professionals through the delegation of skills and appropriate training,
- center care around the patient and his family and more generally his caregivers,
- simplify the monitoring and treatment protocols,
- support patients in their community and emphasize prevention, information and patient education.
A first step of observation in the various countries made it possible to make an inventory of fixtures and to target the most adapted interventions.
The following steps are the implementation of these interventions (delegation of skills, information campaign and screening, improve the availability of treatments, measure of strengthening of compliance, etc. ..) and their evaluation.
This study, carried out in France and integrated into the SPICES project, will test the best non-pharmacological interventions selected in the community and by the community.
- Conditions
- Cardiovascular Risk Factors
- Being tested
- Multi-behavioral intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-behavioral interventionOther
The interventional group will then meet regularly under the aegis of the trainer to work on modifying each person's risk factors. The one-hour sessions will be scheduled every two weeks for two months and then every month for two months and then every three months until the end of the study (13 sessions). These sessions will be behavior change sessions, focused on goal setting, action planning, and problem solving. Trainers will facilitate these sessions and use motivational interviewing techniques
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Only measurement of clinical endpoints at time zero, then at 6, 12, 18 and 24 months and minimal counseling. |
| Interventional group | Other | Measurement of clinical endpoints at time zero, then at 6, 12, 18 and 24 months and minimal counseling followed by multi-behavioral intervention adapted to local resources. Receives: Other: Multi-behavioral intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the non laboratory Interheart risk score
Comparison of the Non Laboratory Interheart risk average score between the two arms at 24 months. This scale is used to predict incident cardiovascular disease.This score is summed and is calculated from questions about family history, type of diet and sports activities.
Measured: 24 months
Secondary outcomes (6)
Measurement of the quality of life
Quality of life evaluated by the World Health Organization Quality of Life (WHOQOL scale brief). This questionnaire contains two items from the Overall Quality of Life and General Health, and one item from each of the 24 facets included in The WHOQOL-100. It assesses the individual's perceptions in the context of their culture and value systems, and their personal goals, standards and concerns.The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The score is summed.
Measured: 24 months
BMI
Reduction of BMI
Measured: 24 months
Evaluation of the level of smoking
Reduction of the number of smokers / reduction of the number of cigarettes per smoker
Measured: 24 months
Improvement of the diet
Improvement of the diet with the Dietary Approaches to Stop Hypertension Quality questionnaire (DASH-Q). This questionnaire was developed in 1997, emphasizing on 8 components: high consumption of fruits, vegetables, whole grains, low-fat dairy foods, legumes and nuts, and low intake of sodium, sweetened beverages, and red and processed meat. The total score is summed.
Measured: 24 months
Level of physical activity
Level of physical activity by the International Physical Activity Questionnaire (IPAQ). This questionnaire comprises a set of 4 questionnaires. Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity.The total score is summed.
Measured: 24 months
Alcohol consumption
Alcohol consumption by collecting the reported weekly consumption of alcohol
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start16 Apr 2019
- Primary completion5 Jan 2022
- Study completion5 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 583 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
- NCT03886064
- Sponsor's protocol ID
- 29BRC18.0256_Spices_phase_2
- Acronym
- Spices_phase_2
- Status last verified
- Mar 2022
- First submitted
- 20 Mar 2019
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Publications
Le Goff D, Aerts N, Odorico M, Guillou-Landreat M, Perraud G, Bastiaens H, Musinguzi G, Le Reste JY, Barais M. Practical dietary interventions to prevent cardiovascular disease suitable for implementation in primary care: an ADAPTE-guided systematic review of international clinical guidelines. Int J Behav Nutr Phys Act. 2023 Jul 28;20(1):93. doi: 10.1186/s12966-023-01463-9.
PubMed 37507692Le Goff D, Barais M, Perraud G, Derriennic J, Aujoulat P, Guillou-Landreat M, Le Reste JY. Innovative cardiovascular primary prevention population-based strategies: a 2-year hybrid type 1 implementation randomised control trial (RCT) which evaluates behavioural change conducted by community champions compared with brief advice only from the SPICES project (scaling-up packages of interventions for cardiovascular disease prevention in selected sites in Europe and sub-Saharan Africa). BMC Public Health. 2021 Jul 19;21(1):1422. doi: 10.1186/s12889-021-11443-y.
PubMed 34281516
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. 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. SPICES Study Implementation Phase
- ClinicalTrials.gov ID
- NCT03886064
- Acronym / sponsor ID
- Spices_phase_2 / 29BRC18.0256_Spices_phase_2
- Conditions
- Cardiovascular Risk Factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 583 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- ERCR SPURBO
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 22 Mar 2019 (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 (CVD) is the leading cause of death in the world. 17.5 million people died in 2012 due to CVD (31% of all causes of death). In Europe more than 50% of deaths are due to CVD. The CVD mortality rate is higher in the lower socio-economic levels. Three quarters of CVD deaths occur in developing countries (LDCs). According to estimates in 2030, CVD will be responsible for more deaths than the sum of infectious, nutritional, maternal and perinatal diseases in developing countries. The lack of an adequate primary care network in developing countries limits the screening and treatment of people with CVRF. As a result, these people do not benefit from appropriate 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.
Cardiovascular risk factor prevention measures (CVRF) have been shown to be effective. Interventions are possible on a large scale (policies against smoking and unfavorable eating habits, promoting physical activity, etc.). Actions are possible at the individual level, both in primary prevention (fight against the FDRCV) and secondary, where many treatments have proven their effectiveness. These interventions are effective and profitable from a macroeconomic point of view. It has been estimated that the cost for such interventions would not exceed 4% of health expenditure in developing countries and 1-2% in rich countries.
The World Health Organization (WHO) stresses the importance of the triad composed by the patient and his family, the community and health professionals. Results are possible only when these three components work together for the same purpose. Many studies show the benefit of people's involvement in care in rich and developing countries.
SPICES project builds on progress in HIV / AIDS treatment in sub-Saharan Africa (SSA) and chronic disease management through the Innovative Care for Chronic Conditions (ICCC Framework), WHO plan. With regard to HIV treatment, these interventions have proven to be effective and cost-effective in many SSA countries, both in terms of disease control and adherence. These data on communicable and infectious diseases seem to be transferable to non-communicable diseases.
These projects were born from the observation that the model of care of the rich countries (individual approach of the patient, centered on the hospital and the specialist with a regular clinical and paraclinical follow-up) could not be transposed to the developing countries, because the limitation of human, technical and financial resources. But also that this model was becoming more and more difficult to maintain in developed countries or resources become limited. New approaches need to be developed to increase the effectiveness of health systems.
A paradigm shift is needed to improve the control of CVD with greater cost-effectiveness.
The SPICES project incorporates the most up-to-date knowledge to improve the prevention and control of CVD in high-, middle- and low-income countries.
Rich countries and developing countries are therefore involved in the study. The selected sites are France, United Kingdom, Belgium, South Africa and Uganda.
Some main axes of the ICCC Framework will be developed in SPICES:
- improve the efficiency of health professionals through the delegation of skills and appropriate training,
- center care around the patient and his family and more generally his caregivers,
- simplify the monitoring and treatment protocols,
- support patients in their community and emphasize prevention, information and patient education.
A first step of observation in the various countries made it possible to make an inventory of fixtures and to target the most adapted interventions.
The following steps are the implementation of these interventions (delegation of skills, information campaign and screening, improve the availability of treatments, measure of strengthening of compliance, etc. ..) and their evaluation.
This study, carried out in France and integrated into the SPICES project, will test the best non-pharmacological interventions selected in the community and by the community.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Only measurement of clinical endpoints at time zero, then at 6, 12, 18 and 24 months and minimal counseling. |
| Interventional group | Other | Other: Multi-behavioral interventionMeasurement of clinical endpoints at time zero, then at 6, 12, 18 and 24 months and minimal counseling followed by multi-behavioral intervention adapted to local resources. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Within the general population, all persons over 18 years of age living or working in the country Center Bretagne (including Pays Pays Ouest Bretagne, Pleyben and Callac) with a moderate cardiovascular risk score based on the Interheart clinical risk score (score 9-15).
Key exclusion criteria (5 listed)
- Pregnancy
- Age under 18 years old
- Patient in secondary cardiovascular prevention
- Nobody living or working in Central Brittany (Pays Center Ouest Bretagne and Pays de Pleyben and Callac)
- Low (<9) or high cardiovascular risk score by Interheart score (> 15).
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 |
|---|---|---|
| Multi-behavioral interventionThe interventional group will then meet regularly under the aegis of the trainer to work on modifying each person's risk factors. The one-hour sessions will be scheduled every two weeks for two months and then every month for two months and then every three months until the end of the study (13 sessions). These sessions will be behavior change sessions, focused on goal setting, action planning, and problem solving. Trainers will facilitate these sessions and use motivational interviewing techniques | Other | Interventional group |
Primary outcome
Measurement of the non laboratory Interheart risk score
Time frame: 24 months
Comparison of the Non Laboratory Interheart risk average score between the two arms at 24 months. This scale is used to predict incident cardiovascular disease.This score is summed and is calculated from questions about family history, type of diet and sports activities.
6 secondary outcomes
Measurement of the quality of life
Time frame: 24 months
BMI
Time frame: 24 months
Evaluation of the level of smoking
Time frame: 24 months
Improvement of the diet
Time frame: 24 months
Level of physical activity
Time frame: 24 months
Alcohol consumption
Time frame: 24 months
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 16 Mar 2022.
- Derived from this study: PubMed 37507692Le Goff D, Aerts N, Odorico M, Guillou-Landreat M, Perraud G, Bastiaens H, Musinguzi G, Le Reste JY, Barais M. Practical dietary interventions to prevent cardiovascular disease suitable for implementation in primary care: an ADAPTE-guided systematic review of international clinical guidelines. Int J Behav Nutr Phys Act. 2023 Jul 28;20(1):93. doi: 10.1186/s12966-023-01463-9.
- Derived from this study: PubMed 34281516Le Goff D, Barais M, Perraud G, Derriennic J, Aujoulat P, Guillou-Landreat M, Le Reste JY. Innovative cardiovascular primary prevention population-based strategies: a 2-year hybrid type 1 implementation randomised control trial (RCT) which evaluates behavioural change conducted by community champions compared with brief advice only from the SPICES project (scaling-up packages of interventions for cardiovascular disease prevention in selected sites in Europe and sub-Saharan Africa). BMC Public Health. 2021 Jul 19;21(1):1422. doi: 10.1186/s12889-021-11443-y.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-behavioral intervention in people with Cardiovascular Risk Factors, run by University Hospital, Brest at 2 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 1 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 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Measurement of the non laboratory Interheart risk score (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03886064, which also lists 2 linked publications.
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 16 Mar 2022.