Atrial fibrillation Circulatory System Atrial fibrillation and flutter
Conditions
Interventions
Current interventions as of 22/02/2022:
This trial has been carefully designed in consultation with the UK National Screening Committee to mimic as closely as possible a 'real life' national screeni
Sponsors
University of Cambridge
NHS Cambridgeshire & Peterborough Integrated Care Board (ICB)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have given informed consent to participate 2. Be aged 70 years or over
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 08/01/2024 to 25/07/2022: 1. On anticoagulation therapy 2. On the practice palliative care register 3. Resident in a nursing or care or residential home 4. Consented to another trial that will affect participation in SAFER 5. Non-UK resident _____ Previous exclusion criteria as of 25/07/2022: 1. On long-term anticoagulation therapy 2. On the practice palliative care register 3. Resident in a nursing or care or residential home 4. Consented to another trial that will affect participation in SAFER 5. Non-UK resident _____ Previous exclusion criteria: 1. Long-term anticoagulation therapy for stroke prevention 2. On the palliative care register 3. Resident in a nursing/care/residential home
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 04/07/2023: Stroke incidence, defined as stroke of any severity but excluding transient ischaemic attack. Ischaemic and haemorrhagic stroke will be combined. Collection of stroke incidence will be via electronic health registries (including HES, ONS and SSNAP) and GP medical records, approximately annually for an average of 4 years. Previous primary outcome measure: Stroke incidence, defined as stroke of any severity but excluding transient ischaemic attack. Ischaemic and haemorrhagic stroke will be combined. Collection of stroke incidence will be via electronic health registries (including HES, ONS and SSNAP) and GP medical records, approximately annually for an average of 5 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 08/01/2024 to 04/07/2023: Collected via electronic health registries (including HES, ONS, MiNAP and SSNAP) and GP medical records, for an average of 4 years: 1. Bleeding episode requiring hospital admission (including haemorrhagic stroke, to be reported separately) 2. Myocardial infarction; ischaemic stroke 3. Cardiovascular events (myocardial infarction + stroke + other admissions for cardiovascular disease – including heart failure) 4. All-cause mortality 5. Cardiovascular mortality 6. Dementia 7. AF detection rates 8. Anticoagulation rates 9. New diagnoses of depression and anxiety 10. Psychological effects of screening and impact on functional status assessed using the Spielberger state trait anxiety inventory (STAI), EQ5-D and Short-form 8 (SF-8) questionnaire posted to a random sample of participants in intervention and control practices at baseline and post-invitation to the trial (pilot trial only) Previous secondary outcome measures as of 04/07/2023: Collected via electronic health registries (including HES, ONS, MiNAP and SSNAP) and GP medical records, approximately annually for an average of 4 years: 1. Bleeding episode requiring hospital admission 2. Myocardial infarction 3. Cardiovascular events (myocardial infarction + stroke + other admissions for cardiovascular disease – including heart failure) 4. All-cause mortality 5. Cardiovascular mortality 6. Dementia 7. AF detection rates 8. Anticoagulation rates 9. New diagnoses of depression and anxiety 10. Psychological effects of screening and impact on functional status assessed using the Spielberger state trait anxiety inventory (STAI), EQ5-D and Short-form 8 (SF-8) questionnaire posted to a random sample of participants in intervention and control practices at baseline and post-invitation to the trial Previous secondary outcome measures: Collected via electronic health registries (including HES, ONS, MiNAP and SSNAP) and GP medical records, approximately annual | — |
Countries
England, United Kingdom
Outcome results
None listed