Cardiovascular disease - preventing heart attack and stroke Circulatory System
Conditions
Interventions
Participants will be randomised using an online randomization generator (http://www.randomization.com) to one of three arms: usual care, blinded n-of-1 experiment, and open-label n-of-1 experiment.
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Any patient that: 1. Is 18 years of age or older 2. Requiring statin therapy according to NICE guidelines and the GP thinks statins are indicated 3. Has previously been prescribed/recommended statin treatment 4. Has stopped/is considering stopping statin treatment/ or has not started statin treatment due to concerns about or experience of side-effects 5. Is willing and able to give informed consent for participation in the study and comply with study procedures 6. If on ezetimibe or another alternative to atrovstatin, willing to potentially cease said medication if randomised to one of the intervention arms
Exclusion criteria
Exclusion criteria: Any patient that: 1. The GP thinks it is not indicated to recommence statins or the previous intolerance was severe enough to mean that recommencing statins may comprise a significant risk to health 2. Is unable to adhere to study procedures through illness or infirmity 3. Has any contraindications listed in the Summary of Product Characteristics (SmPC) for atorvastatin 20mg or placebo drug, including pregnancy 4. Is participating in any research project that may interact with the current study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The proportion of invited patients who enrol in the trial. 2. The proportion of enrolled participants who accept GPs behavioural intervention. 3. Proportion of patients in the treatment conditions who decide to continue statin therapy compared to the proportion who decide to continue statin therapy in the usual care control arm. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Difference in the proportion of participants who decide to continue statin therapy in the ‘open-label’ (unblinded) treatment arm (i.e. alternating between medication and no treatment) compared to the proportion of participants who decide to continue statin therapy in the ‘closed-label’ (blinded) treatment arm (i.e. alternating between statin and placebo) and compared to the proportion of participants receiving usual care (control arm). Timepoint: 24 week follow up; decision to persist with statin therapy treatment full time. 2. Count of the number of adverse events by system class and preferred term level (according to MedDRA) in the blinded arm compared to the unblinded arm. Timepoint: 24 week follow up. Analysis of the symptom diary. 3. Count of the number of times that participant attributes side effects to statin medication in blinded arm compared to the unblinded arm. Timepoint: 24 week follow up; analysis of symptom diary. 4. The difference in mean pain severity (taken from Brief Pain Inventory) scores between statin therapy and placebo in the open label arm compared to the closed label arm. Timepoint: 24-week follow up; analysis of symptom diary. 5. The difference in mean pain interference scores (taken from the brief pain inventory) between statin therapy and placebo in the open-label arm compared to the closed label arm. Timepoint: 24-week follow up; analysis of symptom diary. 6. If applicable, focus groups with patients who declined to participate in the main study on the reasons for this decision. Timepoint: focus groups after recruitment period ends. 7. Compare participant BMQ scores before and after the intervention. Compare BMQ score changes between study groups. Timepoint: 24 week follow up. | — |
Countries
England, United Kingdom
Contacts
Public ContactPaul Aveyard
Outcome results
None listed