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Effectiveness of the Ready to Reduce Risk (3R) complex intervention for the primary prevention of cardiovascular disease: a pragmatic randomised controlled trial

journal contribution
posted on 11.06.2020, 10:52 by Jo Byrne, Helen Dallosso, Stephen Rogers, Laura Gray, Ghazala Waheed, Prashanth Patel, Pankaj Gupta, Yvonne Doherty, Melanie Davies, Kamlesh Khunti

Background

Cardiovascular disease is responsible for 31% of all global deaths. Primary prevention strategies are needed to improve longer term adherence to statins and healthy lifestyle behaviours to reduce risk in people at risk of cardiovascular disease.

Methods

Pragmatic randomised controlled trial recruited between May 2016 and March 2017 from primary care practices, England. Participants (n=212) prescribed statins for primary prevention of cardiovascular disease with total cholesterol level ≥ 5 mmol/l were randomised: 105 to intervention group and 107 to control group, stratified by age and sex. 3R intervention involved two facilitated, structured group education sessions focusing on medication adherence to statins, lifestyle behaviours and cardiovascular risk, with 44 weeks of medication reminders and motivational text messages and two supportive, coaching phone calls (at approximately 2 weeks and 6 months). The control group continued with usual clinical care. Both groups received a basic information leaflet. Primary outcome was medication adherence to statins objectively measured by a biochemical urine test. Self-reported adherence and practice prescription data provided additional measures. Secondary outcomes included cholesterol profile, blood pressure, anthropometric data, cardiovascular risk score, and self-reported lifestyle behaviours and psychological measures (health/medication beliefs, quality of life, health status). All outcomes were assessed at 12 months.

Findings

Baseline adherence to statins was 47% (control); 62% (intervention). No significant difference between groups found for medication adherence to statins using either the urine test (OR 1.02, 95% CI 0.34 to 3.06, p=0.968) or other measures. This may have been due to higher than expected adherence levels at baseline. Adjusted mean difference between groups (in favour of intervention group) for diastolic blood pressure ((-4.28 mm/HG (95% CI -0.98 to -1.58, P=0.002) and waist circumference ((-2.55 cm (95% CI -4.55 to -0.55, P=0.012)). Intervention group also showed greater perceived control of treatment and more coherent understanding of condition.

Conclusions

3R programme successfully led to longer term improvements in important clinical lifestyle indicators but no improvement in medication adherence, raising questions about suitability of such a broad, multiple risk factor approach for improving medication adherence for primary prevention of CVD.

Trial Registration

International Standard Randomized Controlled Trial Number (ISRCTN): 16863160

Funding

The research was funded by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care East Midlands and the NIHR Leicester Biomedical Research Centre. The views expressed are those of the authors and not necessarily those of the UK National Health Service, the NIHR, or the UK Department of Health.

History

Citation

BMC Medicine (2020) In Press

Version

AM (Accepted Manuscript)

Published in

BMC Medicine

Publisher

BioMed Central

issn

1741-7015

Acceptance date

11/06/2020

Copyright date

2020

Language

en

Publisher version

TBA