DaRe2THINK
Research type
Research Study
Full title
Preventing stroke, premature death and cognitive decline in a broader community of patients with atrial fibrillation using healthcare data for pragmatic research: A randomised controlled trial
IRAS ID
290420
Contact name
Dipak Kotcha
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2020-005774-10
Duration of Study in the UK
10 years, 0 months, days
Research summary
The DaRe2 approach (healthcare Data for pragmatic clinical Research in the NHS – primary 2 secondary) will test a new way of running trials which could improve the health and well-being of those treated by the NHS, whilst reducing the time needed from staff and patients to engage in research.
As an example of this new system, DaRe2THINK will target patients with Atrial fibrillation. AF is a common heart rhythm condition that leads to a high chance of stroke, frequent hospital admissions, a higher risk of cognitive decline and dementia. Blood thinning tablets (anticoagulants) greatly reduce the number of patients with AF that will suffer a stroke, but are usually only given to older patients or those with other health issues. This leaves patients younger than 65 years, and some patients aged 65-75 without treatment that could prevent these devastating complications.
The trial will include 3,000 patients from up to 600 GP surgeries across England. Each patient will be randomised to either continue their current treatment or start an additional blood thinning tablet. Patients will be followed up remotely to look at the difference in those who suffer from strokes, blood clots, heart attacks, or other problems with the blood vessels and dementia. Patients will self-report their memory, reaction times and quality of life using simple questionnaires through their mobile phone or the internet, again without needing to revisit their doctor.
A new class of blood thinning tablets are now widely used in the NHS which are more convenient for patients to take, and have a lower risk of bleeding than older treatments. These drugs could provide an effective way to prevent strokes, brain damage and dementia in later life for a broader group of patients, but this needs to be tested in a clinical trial. With the support of a Patient and Public Involvement Team and a national network of research nurses and GPs, the trial will include 3,000 patients from up to 600 GP surgeries across England. Each patient will either continue their current treatment or start an additional blood thinning tablet on a random basis. Patients will be followed up automatically within the NHS to look at the difference in those who suffer from strokes, blood clots, heart attacks, other problems with the blood vessels and dementia. Patients will self-report their memory, reaction times and quality of life using simple questionnaires through their mobile phone or the internet, again without needing to revisit their doctor.
DaRe2THINK will answer important questions for a growing number of patients with AF. The combination of information from the community as well as hospitals across the NHS will allow us to see whether these blood thinning tablets should be prescribed more widely. DaRe2THINK will allow us to develop and improve this new clinical trial system so that future research in the NHS will continue to benefit those patients most in need.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
21/NE/0021
Date of REC Opinion
11 Mar 2021
REC opinion
Further Information Favourable Opinion