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
Protocol serial number HTA 96/22/11
Sponsor Department of Health (UK)
Funder NIHR Health Technology Assessment Programme - HTA (UK)
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

Department of Primary Care & General Practice
University of Birmingham
The Medical School
Birmingham
B15 2TT
United Kingdom

+44 (0)121 415 8019
f.d.r.hobbs@bham.ac.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleRandomised controlled trial and cost effectiveness study of targeted screening versus systematic population screening for atrial fibrillation in the over 65s: the SAFE study
Study acronymSAFE
Study objectives1. 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) studiedCardiovascular diseases: Heart disease
InterventionScreening 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 typeOther
Primary outcome measure(s)

Not provided at time of registration.

Key secondary outcome measure(s)

Not provided at time of registration.

Completion date31/05/2003

Eligibility

Participant type(s)Patient
Age groupSenior
SexAll
Target sample size at registration15000
Key inclusion criteriaPatients over 65 years
Key exclusion criteriaNot provided at time of registration.
Date of first enrolment01/06/2000
Date of final enrolment31/05/2003

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Department of Primary Care & General Practice
Birmingham
B15 2TT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 25/08/2007 Yes No
Results article results 01/06/2014 Yes No
Protocol article protocol 29/07/2004 Yes No
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