Atrial fibrillation Circulatory System Atrial fibrillation
Conditions
Interventions
Current interventions as of 02/05/2023:
Santé-AF is a pragmatic trial and the scope of interventions is broad in order to provide a high degree of generalisability to routine practice. Practitioners d
Sponsors
University of York
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 22/02/2021: 1. Aged between 45 and 70 years 2. Diagnosis of paroxysmal AF between 6 months and years before enrolment 3. Stroke prevention measures offered/applied where indicated 4. Perceptible paroxysmal atrial fibrillation of at least weekly frequency despite current treatment regime 5. Owner of, and able to use, a mobile phone, and willing to use this to receive and respond to study communications 6. Home broadband of sufficient capacity to sustain NT appointments and study assessments 7. Owner of, and able to use, a device equipped with Microsoft Teams video-calling software OR happy to use study iPad 8. Willing to have traditional acupuncture or nutritional therapy adjunctively to usual treatment for AF, or usual treatment alone 9. Willing to travel up to five miles from York Hospital to attend appointments for acupuncture (£5 flat travel costs offset paid per visit) 10. Willing to wear a CardioSTAT® ambulatory ECG device (AED) for 2 x 7 day periods over the course of approximately 3 months, then return it by freepost to the manufacturer for data analysis 11. Speak/understand English well enough to engage meaningfully with interventions and assessments 12. Able to give informed consent _____ Previous inclusion criteria: 1. Aged between 45 and 70 years 2. Diagnosis of paroxysmal AF between 6 months and years before enrolment 3. Stroke prevention measures offered/applied where indicated 4. Perceptible paroxysmal atrial fibrillation of at least weekly frequency despite current treatment regime 5. Owner of, and able to use, a mobile phone, and willing to use this to receive and respond to study communications 6. Willing to have traditional acupuncture or nutritional therapy adjunctively to usual treatment for AF, or usual treatment alone 7. Willing to travel up to five miles from York Hospital to attend appointments for acupuncture/nutritional therapy and assessments (£5 flat travel costs offset paid per visit) 8. Willing to wear a CardioSTAT® ambulatory ECG device (AED) for three, 7 day periods over the course of approximately 6 months, then return it by freepost to the manufacturer for data analysis 9. Speak/understand English well enough to engage meaningfully with interventions and assessments 10. Able to give informed consent
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 22/02/2021: 1. Diagnosed with valvular AF 2. Pacemaker, implantable defibrillator, neurostimulator, any other type of active implantable device fitted 3. Diagnosed with kidney disease levels 4 or 5 4. Diagnosed with terminal or severe illness of any kind 5. Diagnosed with any blood clotting disorder 6. Diagnosed (including self-diagnosis) with any condition or disorder contraindicating suitable moderate exercise 7. Diagnosed (including self-diagnosis) with any eating disorder past or present 8. Pregnant or trying to conceive 9. Currently taking part in other research rendering the participant unable to have either intervention, or which is likely to affect study outcomes, or which renders it unsafe for the participant to continue 10. Currently having or have had in the last six months a course of acupuncture or nutritional therapy 11. Classified as shielding, clinically vulnerable or clinically extremely vulnerable with regard to COVID-19, or living with or bubbled with anyone in any of these categories 12. Regularly using a TENS machine or receiving any kind of energy delivery therapy to the upper torso (diathermy therapy, diagnostic or therapeutic ultrasound, radiation therapy, electrosurgery or x-ray) 13. Any other clinical reason why patient should be excluded, in the clinical judgement of the patient's GP _____ Previous exclusion criteria: 1. Diagnosed with valvular or permanent AF 2. Pacemaker fitted 3. Diagnosed with kidney disease levels 4 or 5 4. Diagnosed with terminal or severe illness of any kind 5. Diagnosed with any blood clotting disorder 6. Diagnosed (including self-diagnosis) with any condition or disorder contraindicating suitable moderate exercise 7. Diagnosed (including self-diagnosis) with any eating disorder past or present 8. Pregnant or trying to conceive 9. Currently taking part in other research rendering the participant unable to have either intervention, or which is likely to affect study outcomes, or which renders it unsafe for the participant to continue
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 05/01/2024: 1. Participants’ willingness to be randomised is evaluated using bespoke/validated questionnaires, semistructured interviews and data gathered from primary care practices during recruitment stage, at baseline only 2. Appropriateness of eligibility criteria is evaluated using bespoke/validated questionnaires at baseline only 3. Participant retention is evaluated using study progress data at 3 months; participant compliance adherence data at baseline and 3 months; SMS poll at baseline; bespoke/validated questionnaires at 3 months 4. Acceptability of interventions is evaluated using SMS poll at baseline; bespoke/validated questionnaires, semi-structured interviews and intervention attendance data at 3 months 5. Acceptability of assessments is evaluated using bespoke/validated questionnaires and semi-structured interviews at baseline and 3 months 6. Effect of ambulatory ECG monitors is evaluated using CardioSTAT® ECG monitors, bespoke self-report symptom diary and bespoke/validated questionnaires at baseline and 3 months 7. Experience of study participation is evaluated using bespoke/validated questionnaires and semistructured interviews at baseline and 3 months 8. The feasibility of all objectives during a pandemic is evaluated as a composite of the above 7 objectives _____ Previous primary outcome measure as of 22/02/2021: 1. Participants’ willingness to be randomised is evaluated using bespoke questionnaires, semistructured interviews and data gathered from primary care practices during recruitment stage, at baseline only 2. Appropriateness of eligibility criteria is evaluated using bespoke questionnaires at baseline only 3. Participant retention is evaluated using study progress data at 3 months; participant compliance data at baseline and 3 months; SMS poll at baseline; bespoke questionnaires at 3 months 4. Acceptability of interventions is evaluated using SMS poll at baseline; bespoke questionnaires, semi-str | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 22/02/2021: There are no secondary outcome measures _____ Previous secondary outcome measures: 1. Participants’ willingness to be randomised is evaluated using bespoke questionnaires, semi-structured interviews and data gathered from primary care practices during recruitment stage, at baseline only 2. Appropriateness of eligibility criteria is evaluated using bespoke questionnaires at baseline only 3. Participant retention is evaluated using study progress data at 3 and 6 months; participant compliance data at baseline,at 3 and 6 months; SMS poll at baseline; bespoke questionnaires at 3 and 6 months 4. Acceptability of interventions is evaluated using SMS poll at baseline; bespoke questionnaires, semi-structured interviews and intervention attendance data at 3 and 6 months 5. Acceptability of assessments is evaluated using bespoke questionnaires and semi-structured interviews at baseline, 3, and 6 months 6. Effect of ambulatory ECG monitors is evaluated using CardioSTAT® ECG monitors, bespoke self-report symptom diary and bespoke questionnaires at baseline, 3, and 6 months 7. Changes in group means to support a decision on progression to a future trial is evaluated using the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire, the EQ-5D-5L questionnaire, a bespoke symptom diary and the CardioSTAT® ECG monitor at baseline, 3, and 6 months 8. Experience of study participation is evaluated using bespoke questionnaires and semi-structured interviews at baseline, 3, and 6 months | — |
Countries
England, United Kingdom
Outcome results
None listed