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)

Delphine Le Goff, Marie Barais, Gabriel Perraud, Jeremy Derriennic, Paul Aujoulat, Morgane Guillou-Landreat, Jean Yves Le Reste, Delphine Le Goff, Marie Barais, Gabriel Perraud, Jeremy Derriennic, Paul Aujoulat, Morgane Guillou-Landreat, Jean Yves Le Reste

Abstract

Background: Cardiovascular diseases (CVD) caused 17.9 million deaths worldwide in 2016, being the world's leading cause of death. Prevention of CVD in high-income countries is expensive and fails to reach the population at risk. In low-income countries, it is under-developed. The SPICES project implements a community-based program to improve CVD prevention in 3 European countries and 2 Sub-Saharan countries, based on using community champions to effect behavioural changes. In France, the project operates in "Pays Centre Ouest Bretagne" (COB) which is the Central West Brittany area, and a vulnerable, rural setting. The aim of this study is to assess this innovative prevention strategy versus brief advice.

Methods: A two-step RCT hybrid type 1 implementation study will first of all screen a population using the Non-Laboratory INTERHEART Score (NL-IHRS) and will involve health-care students at public events in the COB area until 1000 participants have been recruited. Second, a RCT will be carried out. The research team will contact each participant with an intermediate NL-IHRS in order to include them. Participants will be over 18 years of age and work or live in the COB area. Participants will be equally randomised in two groups. The intervention group will receive brief advice plus behavioural change guidance carried out by community champions. The control group will receive brief advice only. The main objective for the RCT is to assess a difference of at least 15% in the NL-IHRS between the two groups after 24 months. The primary outcome will be analysed with intention to treat. Secondary outcomes for the RCT will be assessed using validated questionnaires: the WHOQOL-BREF, the DASH Q questionnaire, the IPAQ-short; smoking level will be assessed according to the NL-IHRS scoring system; a modified self-declared alcohol consumption questionnaire has been developed and gauges will be used to assess BMI. The implementation strategy will use mixed methods: qualitative research methods and quantitative epidemiological studies.

Discussion: A difference in the mean NL-IHRS of 15% will provide an argument in favour of reorganising prevention policies. A substantial change would favour relocating primary prevention from healthcare professionals to lay people and the community.

Trial registration: Clinical Trials NCT03886064 - the study was recorded on ClinicalTrials.gov , the 22nd of March 2019.

Keywords: Cardiovascular system; Community health-care workers; Community participation; Motivational interviewing; Primary prevention.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Study Design. QTI Quantitative Implementation, QLI Qualitative Implementation

References

    1. World Health Organization: Cardiovascular diseases (CVDs). (2017) Accessed 5 Mar 2018.
    1. World Health Organization. Global Action Plan for the Prevention and Control of NCDs. WHO. 2013-2020:2013.
    1. Joseph P, Yusuf S, Lee SF, Ibrahim Q, Teo K, Rangarajan S, Gupta R, Rosengren A, Lear SA, Avezum A, Lopez-Jaramillo P, Gulec S, Yusufali A, Chifamba J, Lanas F, Kumar R, Mohammadifard N, Mohan V, Mony P, Kruger A, Liu X, Guo B, Zhao W, Yang Y, Pillai R, Diaz R, Krishnapillai A, Iqbal R, Yusuf R, Szuba A, Anand SS, PURE INVESTIGATORS Prognostic validation of a non-laboratory and a laboratory based cardiovascular disease risk score in multiple regions of the world. Heart. 2018;104(7):581–587. doi: 10.1136/heartjnl-2017-311609.
    1. Maindal HT, Støvring H, Sandbaek A. Effectiveness of the population-based check your health preventive programme conducted in primary care with 4 years follow-up [the CORE trial]: study protocol for a randomised controlled trial. Trials. 2014;15(1):341. doi: 10.1186/1745-6215-15-341.
    1. Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corrà U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Løchen ML, Löllgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp H, van Dis I, Verschuren WMM, Binno S, ESC Scientific Document Group 2016 European guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2016;37(29):2315–2381. doi: 10.1093/eurheartj/ehw106.
    1. Kristensen ML, Christensen PM, Hallas J. The effect of statins on average survival in randomised trials, an analysis of end point postponement: Table 1. BMJ Open. 2015;5:e007118.
    1. Mendis S. WHO library cataloguing-in-publication data. Geneva: WHO; 2014. Global status report on noncommunicable diseases 2014; pp. 1–302.
    1. Tsolekile LP, Abrahams-Gessel S, Puoane T. Healthcare professional shortage and task-shifting to prevent cardiovascular disease: implications for low- and middle-income countries. Curr Cardiol Rep. 2015;17(12):115. doi: 10.1007/s11886-015-0672-y.
    1. Peters DH, Adam T, Alonge O, Agyepong IA, Tran N. Implementation research: what it is and how to do it. BMJ. 2013;48(8):731–736.
    1. Observatoire régional de santé Bretagne. La santé dans le pays du Centre-Ouest Bretagne. 2010;1–20.
    1. Agence Régionale de Santé. Portrait statistique en santé précarité: Pays du Centre-Ouest Bretagne. 2018.
    1. Tual F, Mille F, Gibot N, Rault M, Le Floch K. Addictions en Bretagne. Tableau de bord 2017. Agence régionale de santé Bretagne 2017.
    1. ARS Bretagne. contrat local de santé: Le pays du Centre Ouest Bretagne. 2017.
    1. Macfarlane A, Teixeira A, Taylor K, Martins C, Guimar B. General practice and the community: research on health service, quality improvements and training. Selected abstracts from the EGPRN meeting in Vigo, Spain, 17–20 October 2019. Eur J Gen Pract. 2020;26(1):42–50. doi: 10.1080/13814788.2020.1861245.
    1. Ministère des Solidarités et de la Santé . Ministère de l’Enseignement supérieur de la Recherche et de L’Innovation. Décret no 2018–472 du 12 juin 2018 relatif au service sanitaire des étudiants en santé. 2018–472. France: Legifrance; 2018.
    1. Kampmeijer R, Pavlova M, Tambor M, Golinowska S, Groot W. The use of e-health and m-health tools in health promotion and primary prevention among older adults: a systematic literature review. BMC Health Serv Res. 2016;16 Suppl 5(Suppl 5):290. 10.1186/s12913-016-1522-3.
    1. The World Health Organization quality of life assessment (WHOQOL) Position paper from the World Health Organization. Soc Sci Med. 1995;41(10):1403–1409. doi: 10.1016/0277-9536(95)00112-K.
    1. Warren-Findlow J, Reeve CL, Racine EF. Psychometric validation of a brief self-report measure of diet quality: the DASH-Q. J Nutr Educ Behav. 2017;49(2):92–99.e1. doi: 10.1016/j.jneb.2016.09.004.
    1. Bull FC, Maslin TS, Armstrong T. Global physical activity questionnaire (GPAQ): nine country reliability and validity study. J Phys Act Health. 2009;6(6):790–804. doi: 10.1123/jpah.6.6.790.
    1. Levitan EB, Wolk A, Mittleman MA. Relation of consistency with the dietary approaches to stop hypertension diet and incidence of heart failure in men aged 45 to 79 years. Am J Cardiol. 2009;104(10):1416–1420. doi: 10.1016/j.amjcard.2009.06.061.
    1. Pinnock H, Barwick M, Carpenter CR, Eldridge S, Grandes G, Griffiths CJ, et al. Standards for reporting implementation studies (StaRI) statement. Bmj. 2017;8:i6795. doi: 10.1136/bmj.i6795.
    1. Summers Holtrop J, Rabin BA. Glasgow RE. Qualitative approaches to use of the RE- AIM framework: rationale and methods. 2018:1–10.
    1. National Institue for Health and Care Excellence. Type 2 diabetes prevention: population and community level interventions [Nice Guideline PH35]. 2011. .
    1. Rubak S, Sandbaek A, Lauritzen T, Christensen B. Motivational interviewing: a systematic review and meta-analysis. Br J Gen Pract. 2005;55(513):305–312.
    1. Odorico M, Le Goff D, Aerts N, Bastiaens H, Le Reste JY. How to support smoking cessation in primary care and the community: a systematic review of interventions for the prevention of cardiovascular diseases. Vasc Health Risk Manag. 2019;15:485–502. doi: 10.2147/VHRM.S221744.
    1. Whittle J, Schapira MM, Fletcher KE, Hayes A, Morzinski J, Laud P, Eastwood D, Ertl K, Patterson L, Mosack KE. A randomized trial of peer-delivered self-management support for hypertension. Am J Hypertens. 2014;27(11):1416–1423. doi: 10.1093/ajh/hpu058.
    1. Epping-Jordan JE, Pruitt SD, Bengoa R, Wagner EH. Innovative care for chronic conditions: building blocks for action: global report. World Heal Organ. 2002;2002:112.
    1. Kessler RS, Purcell EP, Glasgow RE, Klesges LM, Benkeser RM, Peek CJ. What does it mean to “Employ” the RE-AIM model? Eval Health Professions. 2013;36:44–66.
    1. Kirk MA, Kelley C, Yankey N, Birken SA, Abadie B, Damschroder L. A systematic review of the use of the Consolidated Framework for ImplementationResearch. Implement Sci. 2016;11:72. 10.1186/s13012-016-0437-z.

Source: PubMed

스폰서 및 공동 작업자

건강 상태

약물 개입

3
구독하다