Specialty: Cardiovascular disease, Primary sub-specialty:
Conditions
Interventions
Randomisation process:
The study will use simple randomisation method (1:1). Participants will be stratified by age and sex. Participants will be randomised using a password protecte
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 40-74 years old inclusive 2. Prescribed statin medication for primary prevention of CVD that is still active, at least 12 months prior to enrolment 3. TC level =5.0 mmols/L at enrolment 4. Ability to speak and read English to participate effectively in the group education programme 5. Willing and able to attend the education sessions and clinic visits 6. Willing and able to give informed consent 7. Willing to allow GP to be notified of participation in the study, so access postconsent to relevant medical records can be obtained 8. Have access to a mobile phone to receive text messages
Exclusion criteria
Exclusion criteria: 1. Under 40 years of age and 75 years and over 2. Unable or unwilling to give informed consent 3. Preexisting CVD 4. Total cholesterol < 5 mmol/l 5. Inherited lipid disorder 6. Established Type 1 or Type 2 diabetes 7. Females who are pregnant (self reported) 8. Currently participating or participated in another clinical intervention study in the past 12 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 14/06/2018: The primary outcome is medication adherence to statins at 12 months and the primary measure is a urine-based biochemical measure involving a novel assay to test for statin and anti-hypertensive levels in urine samples. In addition, the self-reported Morisky 8-item Medication Adherence Scale is completed at baseline and 12 months. This is an established and validated scale that is commonly used to measure adherence. At the end of the study, practices are asked to provide details for individual participants regarding both statin and antihypertensive (if applicable) prescriptions issued during the 12 months of the study. These data will provide useful supporting information about the pattern of patient medication adherence behaviour over the 12-month study period. Previous primary outcome measures: The primary outcome is a change in medication adherence to statins which will be measured at baseline and 12 months in two ways: 1. Patient self-report (Morisky 8-item Medication Adherence Scale) 2. Biochemical tests, i.e. levels of statins in urine sample | — |
Secondary
| Measure | Time frame |
|---|---|
| Change measured at baseline and 12 months: 1. CVD score: Variables are collected by the study and calculated by online version of QRISK 2. TC (total cholesterol), HDL (High Density Lipoprotein), TC:HDL ratio: Non-fasting blood test taken at study clinic visits 3. Blood pressure: Taken at study clinic visits 4. BMI: Calculated using height and weight taken 5. Waist-to-hip ratio: Waist and hip measurements will be used to calculate a waist-to-hip ratio 6. The following questionnaires will be used: 6.1. Self-reported history of smoking using a standard question format 6.2. Fruit and vegetable consumption using the food frequency section of the validated 5-A-Day Consumption and Evaluation Tool (FACET) which is recommended by the Department of Health will be used to determine dietary intake in conjunction with a NHS Portion Size Guide 6.3. The validated Quality of Life Questionnaire (15D) 6.4. The EQ5D as a validated measure of health status 6.5. The validated International Physical Activity Questionnaire (short form) or IPAQ to obtain internationally comparable data on health–related physical activity 6.6. The Patient Activation Measure (PAM) as a validated measure of patient readiness for health behaviour change 6.7. The Beliefs about Medicines Questionnaire (BMQ)37 and the Brief Illness Perception Questionnaire (IPQ) will be used as validated measures of health and medication beliefs 7. Medication adherence to antihypertensives measured at baseline and 12 months by the following ways: 7.1. Patient self-report (Morisky 8-item Medication Adherence Scale) 7.2. Levels of statins in urine sample; updated 14/06/2018: Levels of anti-hypertensive in urine sample | — |
Countries
United Kingdom
Outcome results
None listed