Randomised controlled trial and cost effectiveness study of targeted screening versus systematic population screening for atrial fibrillation in the over 65s: the SAFE study
| ISRCTN | ISRCTN19633732 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19633732 |
| Secondary identifying numbers | HTA 96/22/11 |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 13/01/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof FD Richard Hobbs
Scientific
Scientific
Department of Primary Care & General Practice
University of Birmingham
The Medical School
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 415 8019 |
|---|---|
| f.d.r.hobbs@bham.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Scientific title | Randomised controlled trial and cost effectiveness study of targeted screening versus systematic population screening for atrial fibrillation in the over 65s: the SAFE study |
| Study acronym | SAFE |
| Study objectives | 1. To establish the incremental cost effectiveness of different screening options (targeted or population screening) compared with routine clinical practice for detection of AF in over 65s. 2. To determine the value of clinical factors and echocardiography in the process of risk stratification for thromboembolic disease in patients with AF. 3. To determine optimal method of AF diagnosis and ECG interpretation. 4. To assess implications for service provision should screening for AF become a national programme. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular diseases: Heart disease |
| Intervention | Screening vs control. 24,000 patients aged over 65 will be identified from approximately 24 purposefully selected general practices from the West Midlands. Patient randomisation will result in 5,000 patients invited for screening with 5,000 control patients from the same practice (Principal-control patients). Control practices will provide a further 4,000 control patients (Practice-controls). Prospective identification of pre-existing risk factors for AF within the screened population (estimated at 2,000 patients) will enable comparison between high risk targeted screening and total population screening. Study outcomes will identify the clinical and cost effectiveness of overall screening strategy (2 options compared), actual screening method (4 methods compared), and screening test interpretation (4 options evaluated). |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration. |
| Secondary outcome measures | Not provided at time of registration. |
| Overall study start date | 01/06/2000 |
| Completion date | 31/05/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 15,000 |
| Key inclusion criteria | Patients over 65 years |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/06/2000 |
| Date of final enrolment | 31/05/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Primary Care & General Practice
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | +44 (0)1132 545 843 |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 29/07/2004 | Yes | No | |
| Results article | results | 25/08/2007 | Yes | No | |
| Results article | results | 01/06/2014 | Yes | No |
