Projects per year
Abstract
Background
Atrial fibrillation is a common cardiac arrhythmia, associated with debilitating symptoms and a decrease in health-related quality of life. Current treatments for atrial fibrillation may not provide symptomatic relief and are associated with risks and adverse responses. Large-scale trials are justified to investigate whether complementary therapies may improve symptoms and/or health-related quality of life in atrial fibrillation. To reduce the uncertainty of a future trial, a feasibility study was carried out.
Design and methods
A three-arm, parallel-group, pragmatic randomised controlled feasibility study recruited 30 participants with paroxysmal AF aged 45–70 from NHS primary care, randomising to Group A (acupuncture + usual care), Group B (nutritional therapy + usual care) or Group C (usual care alone) using a 2:2:1 allocation ratio in favour of the interventions. Interventions were delivered by private practitioners. Seven feasibility objectives were investigated, including participants’ willingness to take part, appropriateness of eligibility criteria, participant retention and acceptability of interventions and study assessments. Additional exploratory feasibility objectives were investigated, including the effect of the COVID-19 pandemic and the safety of interventions. Data was analysed using descriptive statistics and reflexive thematic analysis, and the study used a sequential convergent mixed methods design to understand whether, and why, objectives were feasible and to make recommendations for a future trial.
Results
Five feasibility objectives’ progression criteria were met, one did not meet its progression threshold and one was abandoned as infeasible to analyse but did not affect feasibility. Recommendations for a future trial include changes in eligibility criteria to reflect real-world populations and changes to assessment methods to reduce participant burden. Uncertainty remains around the effect on the feasibility of reversion to pre-COVID therapy and study assessment delivery, including a recommended longer follow-up.
Conclusion
A future large-scale trial was found to be feasible with adjustments, but some uncertainty remains.
Trial registration
ISRCTN13671984. Registered on June 04, 2020.
Atrial fibrillation is a common cardiac arrhythmia, associated with debilitating symptoms and a decrease in health-related quality of life. Current treatments for atrial fibrillation may not provide symptomatic relief and are associated with risks and adverse responses. Large-scale trials are justified to investigate whether complementary therapies may improve symptoms and/or health-related quality of life in atrial fibrillation. To reduce the uncertainty of a future trial, a feasibility study was carried out.
Design and methods
A three-arm, parallel-group, pragmatic randomised controlled feasibility study recruited 30 participants with paroxysmal AF aged 45–70 from NHS primary care, randomising to Group A (acupuncture + usual care), Group B (nutritional therapy + usual care) or Group C (usual care alone) using a 2:2:1 allocation ratio in favour of the interventions. Interventions were delivered by private practitioners. Seven feasibility objectives were investigated, including participants’ willingness to take part, appropriateness of eligibility criteria, participant retention and acceptability of interventions and study assessments. Additional exploratory feasibility objectives were investigated, including the effect of the COVID-19 pandemic and the safety of interventions. Data was analysed using descriptive statistics and reflexive thematic analysis, and the study used a sequential convergent mixed methods design to understand whether, and why, objectives were feasible and to make recommendations for a future trial.
Results
Five feasibility objectives’ progression criteria were met, one did not meet its progression threshold and one was abandoned as infeasible to analyse but did not affect feasibility. Recommendations for a future trial include changes in eligibility criteria to reflect real-world populations and changes to assessment methods to reduce participant burden. Uncertainty remains around the effect on the feasibility of reversion to pre-COVID therapy and study assessment delivery, including a recommended longer follow-up.
Conclusion
A future large-scale trial was found to be feasible with adjustments, but some uncertainty remains.
Trial registration
ISRCTN13671984. Registered on June 04, 2020.
| Original language | English |
|---|---|
| Article number | 21 |
| Number of pages | 18 |
| Journal | Pilot and Feasibility Studies |
| Volume | 11 |
| DOIs | |
| Publication status | Published - 25 Feb 2025 |
Bibliographical note
© The Author(s) 2025Projects
- 1 Finished
-
Sante-AF (Karen Charlesworth)
Watson, J. (Principal investigator)
11/10/19 → 30/09/22
Project: Research project (funded) › Research