NCT03886064: Spices_phase_2

Cardiovascular Disease Prevention in Europe and Sub-Saharan Africa

Completed NA Last updated 16 March 2022

What this trial tests

NA trial testing Multi-behavioral intervention in Cardiovascular Risk Factors in 583 participants. Completed in 5 January 2022.

Timeline

16 April 2019

Primary endpoint
5 January 2022

5 January 2022

Quick facts

Lead sponsor	University Hospital, Brest
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	583
Start date	16 April 2019
Primary completion	5 January 2022
Estimated completion	5 January 2022
Sites	2 locations across France

Drugs / interventions tested

• Multi-behavioral intervention

Conditions studied

• Cardiovascular Risk Factors — all drugs for Cardiovascular Risk Factors →

Sponsor

University Hospital, Brest

Who can join

Adults 18 to 80, any sex, with Cardiovascular Risk Factors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Practical dietary interventions to prevent cardiovascular disease suitable for implementation in primary care: an ADAPTE-guided systematic review of international clinical guidelines.
   Le Goff D, Aerts N, Odorico M, Guillou-Landreat M, et al · · 2023 · cited 8× · PMID 37507692 · DOI 10.1186/s12966-023-01463-9
2. 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 p
   Le Goff D, Barais M, Perraud G, Derriennic J, et al · · 2021 · cited 8× · PMID 34281516 · DOI 10.1186/s12889-021-11443-y