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Effectiveness of the Ready to Reduce Risk (3R) complex intervention for the primary prevention of cardiovascular
Jo L Byrne1, Helen M Dallosso1, Stephen Rogers2,3
1Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.
Insights
The 3R intervention improved lifestyle indicators but not statin adherence for cardiovascular disease prevention. This suggests a broad approach may not be optimal for improving medication adherence in primary prevention.
Area of Science:
- Cardiology
- Public Health
- Behavioral Science
Background:
- Cardiovascular disease (CVD) accounts for 31% of global deaths, necessitating effective primary prevention strategies.
- Improving adherence to statins and healthy lifestyle behaviors is crucial for reducing CVD risk in high-risk individuals.
Purpose of the Study:
- To evaluate the effectiveness of the 3R intervention on medication adherence and clinical outcomes for primary CVD prevention.
- To assess the impact of a multi-faceted intervention on lifestyle behaviors and patient understanding of cardiovascular risk.
Main Methods:
- A pragmatic randomized controlled trial involving 212 participants prescribed statins for primary CVD prevention.
- The 3R intervention included education sessions, medication reminders, motivational messages, and coaching calls over 12 months.
- Primary outcome was objectively measured statin adherence via urine test; secondary outcomes included blood pressure, cholesterol, and lifestyle behaviors.
Main Results:
- No significant difference in statin adherence between the intervention and control groups was observed.
- The intervention group showed significant reductions in diastolic blood pressure and waist circumference.
- Participants in the intervention group reported greater perceived control over treatment and a more coherent understanding of their condition.
Conclusions:
- The 3R program improved key clinical lifestyle indicators but failed to enhance medication adherence for primary CVD prevention.
- Findings question the suitability of broad, multi-risk factor interventions for improving statin adherence in primary prevention settings.
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 the intervention group and 107 to the control group, stratified by age and sex. The 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. The 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.
Results:
Baseline adherence to statins was 47% (control) and 62% (intervention). No significant difference between the 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 the higher than expected adherence levels at baseline. The adjusted mean difference between the groups (in favour of the intervention group) for diastolic blood pressure (- 4.28 mmHg (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)). The intervention group also showed greater perceived control of treatment and more coherent understanding of the condition.
Conclusions:
The 3R programme successfully led to longer-term improvements in important clinical lifestyle indicators but no improvement in medication adherence, raising questions about the 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 (ISRCTN16863160), March 11, 2006.
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