Condition category
Circulatory System
Date applied
29/05/2020
Date assigned
04/06/2020
Last edited
05/06/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Atrial fibrillation (AF) is a common cardiac rhythm disorder which carries an increased risk of stroke. Risk factors include age, lifestyle factors, other conditions such as diabetes or high blood pressure, and heart failure. The incidence of AF in the UK is increasing rapidly in line with an ageing population and unhelpful lifestyle choices, and current costs are estimated at up to 2.4% of total NHS expenditure. Current treatment options are not always successful in reducing symptoms, with up to 50% of patients experiencing recurrence of symptoms within three months of some treatments. Adverse effects of treatment may affect quality of life for some. Management of AF increasingly focuses on improving quality of life and relieving symptoms.

A small body of evidence suggests that traditional acupuncture and nutritional therapy may reduce symptoms and increase quality of life. This feasibility study will test some aspects of a future large-scale trial.

Who can participate?
Patients, aged between 45 and 70 years, with paroxysmal AF that they are aware of (can feel).

What does the study involve?
Participants are randomly allocated to one of three groups: Acupuncture + usual care; Nutritional Therapy + usual care; Usual care alone. In the Acupuncture group, participants will receive up to eight weekly acupuncture treatments with a private acupuncturist while they continue their usual care for AF; in the Nutritional Therapy group, participants will receive up to three monthly nutrition consultations with a private Nutritional Therapy practitioner while they continue their usual care for AF; in the Usual care group, participants receive their usual NHS care for AF only.

The study is aiming to determine the feasibility of a future larger-scale trial, and this means all assessments from the future trial will be carried out at three measurement points. These are at pre-treatment stage, three months and six months. The assessments include: measurements of hip and waist, height, weight and blood pressure; monitoring of medications; questionnaires; takeaway symptom diaries completed over a 7-day period; SMS polling via participants’ mobile phones; and interviews for a sub-set of participants who are willing to be interviewed. 33% of all participants will be randomly chosen to wear a small ECG monitor, the CardioSTAT®, for 7 days, three times during the study.

What are the possible benefits and risks of participating?
Participants in the study are contributing to our knowledge about future potential treatments for AF that may help people with AF to have a better quality of life and fewer symptoms. We cannot promise that people who receive acupuncture or nutritional therapy on the study will definitely experience improved quality of life or reduced symptoms – but the information they give will help us to know whether it is feasible to carry out a large-scale trial to understand the effect of these treatments for people with AF.

There are minimal risks for participants in this study. Acupuncture has a good safety record, although there is a risk of superficial bleeding or bruising particularly if you are taking anti-coagulant drugs. Acupuncturists are trained to adapt treatment to maintain safety. Nutritional Therapy does not have an established safety record, but there are few risks that we have been able to discover in the published literature. Nutritional therapy practitioners are also trained to adapt dietary advice to maintain safety.

Where is the study run from?
The Northern College of Acupuncture (UK). Private practitioners of acupuncture and nutritional therapy participating in the study are located within five miles of central York.

When is the study starting and how long is it expected to run for?
From October 2018 to September 2020

Who is funding the study?
The National Institute of Health Research (NIHR), the British Acupuncture Council (BAcC), and the Northern College of Acupuncture (NCA) (UK)

Who is the main contact?
Ms Karen Charlesworth
kc1206@york.ac.uk

Trial website

http://www.sante-af.org

Contact information

Type

Scientific

Primary contact

Ms Karen Charlesworth

ORCID ID

http://orcid.org/0000-0003-0580-5652

Contact details

Northern College of Acupuncture
York
YO1 6LJ
United Kingdom
+44 (0)1904 343305
kc1206@york.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 45473, IRAS 200530

Study information

Scientific title

Sessions of Acupuncture and Nutritional Therapy Evaluation for Atrial Fibrillation (Santé-AF): a feasibility study to inform a randomised controlled trial

Acronym

Santé-AF

Study hypothesis

It would be feasible to conduct a larger-scale trial to compare the outcomes of (i) acupuncture + usual care; (ii) nutritional therapy + usual care; (iii) usual care alone, in patients with atrial fibrillation.

Ethics approval

Pending

Study design

Three-arm, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Atrial fibrillation

Intervention

The feasibility study design has been chosen as an appropriate first step in an overall research programme to test the effectiveness of two interventions in relation to atrial fibrillation (AF). A control arm has been included to compare the relative effectiveness of each group in comparison to the control, in addition to comparison with each other.

Recruitment:
Participants will be identified using a subset of eligibility criteria from a computerised search of medical records held in primary care practices. Patients will be sent by post a Permission to Approach pack, returned directly to the researcher. On return of a signed Permission to Approach form, a Participant Information Sheet and the Consent Form will be sent by post, followed by a phone call from the researcher to enable the patient to ask any questions. On receipt of a signed Consent Form, the researcher will carry out a screening phone call with the patient, to determine self-reported eligibility.

Eligible patients' records will undergo a final screen by medical staff at the patient's primary care practice, to confirm eligibility. Patients who are contraindicated to participate will be notified by letter. Patients who are confirmed eligible to participate will be notified by letter and invited to attend the study centre for a baseline assessment.

Randomisation will use the Simple + randomisation facility provided by Sealed Envelope Limited, and will employ a randomly permuted blocked allocation sequence using an allocation ratio of 2:2:1 in favour of the intervention groups, block sizes of 5 and 10, and a list length of 30. A further simple randomisation list will be created in Microsoft Excel to randomise the participants in each group who will be asked to wear an ambulatory ECG device.

The researcher will send a letter to each participant randomised, to inform them of group allocation. The letters to those in active intervention groups will also contain details of the practitioner to whom the participant has been allocated, and participants will be encouraged to call the practitioner to arrange a first appointment. SMS reminders will be sent after 4 days and 8 days. Participants who do not wish to attend their allocated practitioner will be offered an alternative practitioner.

Assessments:
Three assessments will be carried out at baseline, end of intervention (approximately 3 months post-randomisation) and final follow-up (approximately 6 months post-randomisation). These will be carried out at the study centre (Northern College of Acupuncture, York).

Assessments comprise of: two text messages to ascertain allocation satisfaction and treatment expectation; a selfreport questionnaire; anthropometric measures including height, weight, hip/waistline measurements, a blood pressure reading and details of current medications including dosage; a 7-day AF self-reported symptom diary. 33% of participants in each group will be fitted with a CardioSTAT® baseline ambulatory ECG device (AED) to measure frequency, duration and severity of AF episodes objectively.

Participants are asked at consent stage whether they are willing to be interviewed, using a semi-structured interview format, regarding their experience of AF, their treatment/consultation, and their participation in the study. Purposeful sampling (maximal variation) will be employed to select from the pool of willing participants within each group according to maximum variation possible across four key characteristics: age, gender, length of diagnosis, and previous experience of complementary therapies. Assessments are expected to take no longer than 40 minutes, with an additional 40 minutes for interviews if the participant has been selected for interview. Assessments and interviews will be carried out by the researcher.

Sampling strategy and sample sizes As this is a feasibility study of n=30, it is not powered to support meaningful analysis regarding the interventions’ effectiveness; instead, data is collected primarily to investigate the feasibility of data collection methods/instruments. However, a sample size has been calculated to support a decision on progression to a future definitive trial on the basis of a statistically significant difference in the main outcome measures.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Health-related quality of life measured using the EuroQol Group 5-dimension questionnaire (EQ-5D-5L) and the Atrial Fibrillation Quality of Life Evaluation questionnaire (AFEQT) at baseline, 3, and 6 months
2. AF symptom severity measured using a patient symptom diary and data from CardioSTAT® ambulatory ECG monitors at baseline, 3, and 6 months

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

Overall trial start date

01/10/2018

Overall trial end date

30/09/2020

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 30; UK Sample Size: 30

Participant 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

Recruitment start date

01/09/2020

Recruitment end date

01/12/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Northern College of Acupuncture
61 Micklegate
York
YO1 6LJ
United Kingdom

Trial participating centre

MyHealth Group
Strensall Health Care Centre Southfields Road Strensall
York
YO32 5UA
United Kingdom

Trial participating centre

York Medical Group
Acomb Medical Practice 199 Acomb Road Acomb
York
YO24 4HD
United Kingdom

Trial participating centre

Unity Health
Kimberlow Hill Surbery Kimberlow Rise
York
YO10 5LA
United Kingdom

Trial participating centre

Priory Medical Group
Priory Medical Centre Cornlands Road Acomb
York
YO24 3WX
United Kingdom

Trial participating centre

Jorvik Gillygate Practice
Woolpack House The Stonebow
York
YO1 7NP
United Kingdom

Sponsor information

Organisation

University of York

Sponsor details

Research and Development Directorate
RCH/135
Ron Cooke Hub
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904328693
michael.barber@york.ac.uk

Sponsor type

University/education

Website

http://www.york.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Funder name

The British Acupuncture Council

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Northern College of Acupuncture

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer-reviewed scientific journal, conference presentations, and presentations to patient support groups.

IPD Sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/09/2021

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/06/2020: Internal review. 29/05/2020: Trial’s existence confirmed by the National Institute of Health Research (NIHR).