OPTIMISE1
Research type
Research Study
Full title
A randomised clinical trial for OPTIMISation of cardio-renal-metabolic-pulmonary disease guideline adherence in high risk community dwelling individuals and Evaluation of outcomes
IRAS ID
343919
Contact name
Jean Uniacke
Contact email
Sponsor organisation
University of Leeds
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 31 days
Research summary
Cardiovascular disease (CVD) causes a quarter of all deaths in the UK. This is the single biggest area where the NHS can save lives by detecting and treating risk factors early.
Improvements in control of blood pressure, cholesterol, diabetes, kidney disease, as well as weight loss in individuals who are obese, have been shown to reduce the risk of CVD and death. The NHS has guidelines for investigations and treatments for risk factors recommended by the National Institute for Health and Care Excellence (NICE).
Though it is known that better control of risk factors will reduce the risk of CVD we do not know whether having extra appointments in primary care with heart specialists can lead to better treatment and better control of risk factors.
The OPTIMISE trial will compare patients who have consultations at a local GP practice by a cardiology professional to optimise the treatment of their risk factors (OPTIMISE) with those patients who receive standard care (Standard care). Standard care is patients being seen by their GP at routine care appointments.Participants in the OPTIMISE arm will be reviewed by the cardiology professional and recommended treatment in line with current NICE guidance. They will be seen at 3 months to review their treatment and potentially adjusted to ensure it meets NICE guidelines.
Participants in the standard arm will have data related to their cardiovascular, renal, metabolic and pulmonary risk factors collected through their EHR.
At 6 months, all participants will be seen to find out changes to their prescribed medication and the effect of this on their blood pressure and body mass index (BMI) and if indicated in NICE guidance blood tests for cholesterol and blood sugar level and urine tests for kidney disease.
All participants will also complete a quality of life questionnaire prior to randomisation study and at 6 months to identify any differences between the arms and time points.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
24/NE/0188
Date of REC Opinion
23 Dec 2024
REC opinion
Further Information Favourable Opinion