The 3R Study (Ready to Reduce Risk)
A randomised controlled trial to investigate the effect of structured education on medication adherence and lifestyle factors in people at high risk of cardiovascular disease. (3R Study)
Study title
Background
People at risk of having a heart attack or a stroke increase this risk by not taking statins and by not leading a healthy lifestyle. Interventions that encourage people to take the statins they are prescribed and to follow a healthy lifestyle have been shown to improve medication adherence. Further research is needed to see if these improvements are sustained
Study Aims
The study aimed to see whether a new intervention, involving two group education sessions followed by text messages and phone calls to remind people to take their statins and encourage a healthy lifestyle, leads to better medication adherence and lifestyle habits.
Study Summary
The study was a single-centre two-arm parallel 12-month RCT. Participants were aged 40 to 74 years, had been prescribed statins for at least one year and had a total cholesterol >5 mmol/l. It involved a ‘usual’ care control and an intervention involving ‘usual’ care plus a 2-session group education programme with text message and phone support. Additionally, both intervention groups were supported by a detailed information leaflet about statins. The primary outcome was medication adherence, measured objectively at 12-months using a newly developed urine test.
Study Findings
We recruited 212 people in total with an average age of 64 years. We did not find any improvements in medication adherence but we did find some important differences in blood pressure, waist circumference and the participants’ knowledge and control about their risk of heart disease and stroke between the groups, which suggest some lifestyle changes had been made.
Funding and Sponsorship
The project was funded by the National Institute for Health Research (NIHR), Collaboration for Leadership in Applied Health Research and Care (CLAHRC) East Midlands, now recommissioned as the NIHR Applied Research Collaboration East Midlands (ARC EM). Additional funding was provided from the East Midlands Academic Health Science Network (EMAHSN) and Janssen-Cilag Ltd for the development of the educational intervention. The study was sponsored by the University of Leicester.
Study Publications
Research Team
Principle Investigator: Prof Kamlesh Khunti
Project Manager: Dr Jo Byrne
Email: jo.l.byrne@uhl-tr.nhs.uk