Santé-AF has been designed as a three-arm randomised controlled trial. It is a pragmatic trial, meaning that practitioners in the trial will work as they normally do, without adapting their practice in any way for the trial. With this approach, the trial results are thought to be more likely to reflect what might happen “in real life”.
Santé-AF is also an open trial. This means that acupuncturists and nutritional therapists will not be blinded to the treatment they are giving. Blinding is a research term meaning that the doctor doesn’t know what drug they are giving – whether it’s the ‘active’ drug or a placebo. But it’s not possible for an acupuncturist or a nutritional therapist not to know what treatment they are giving, so we can’t blind the therapists. For the same reasons, participants will not be blinded to the treatment they are receiving (because it is also impossible to blind a participant to whether they are receiving acupuncture or nutritional therapy). Some of the trial’s assessments will be carried out blind, meaning that the assessors will not know which treatment the participants have received.
Confidentiality in the Santé-AF study: The identity of each participant in the study is kept confidential by assigning each person a unique code, known as a Study ID. The look-up table that links the code to the person’s actual identity is stored securely and accessed only by the researcher. The Study ID is used on all documents so that even though the documents contain personal data, this cannot be linked with an identifiable individual. This approach to confidentiality is maintained throughout the study, even when the results are published: there is no danger that an individual will be identified. If you would like to know more about confidentiality, data storage and compliance with GDPR in the Santé-AF study, please email the researcher.
What are the three groups (arms) in the study?
In the Acupuncture group, people will receive a series of eight weekly acupuncture treatments in addition to their usual NHS care. If you sign up for the trial, there is a 2 in 5 chance of being assigned to the Acupuncture group.
In the Nutritional Therapy group, people will receive a series of three monthly nutritional therapy consultations in addition to their usual care. If you sign up for the trial, there is a 2 in 5 chance of being assigned to the Nutritional Therapy group.
In the Usual Care group, people will ONLY get their usual NHS care (they won’t have acupuncture or nutritional therapy in addition to their usual care). If you sign up for the trial, there is a 1 in 5 chance of being assigned to the Usual Care group.
All 30 people enrolled in the study will continue with their usual NHS care (which might be medications or procedures, or a mix – or no NHS treatment at all if that’s what they’ve chosen).
The researchers have no control over which group you are assigned to. This is a process known as randomisation, and it’s important that people are randomly assigned to these groups so that the study can draw reliable conclusions.
What is being assessed, and how?
For all groups, we will measure the following things at the start of the study (baseline) and after three months (follow-up):
- AF symptoms using a seven-day symptom diary that people will fill in themselves. For 10 randomly-selected people on the study, we will also measure symptoms using a CardioSTAT® 7-day ECG heart monitor.
- Quality of life using two validated questionnaires (the EQ-5D and AFEQT).
For all groups, we will also use a questionnaire at baseline and follow-up to get more information about:
- participants’ willingness to take part;
- acceptability of therapies;
- acceptability of study assessments;
- participants’ characteristics including gender, ethnicity, employment, education and health;
- participants’ use of healthcare and self-care;
- participants’ Covid status and vaccination status.
Approximately 10 people will be interviewed at baseline and follow-up, to get more in-depth information on their reasons for taking part, and to understand more about their experience of AF and their treatments.
Other things are assessed without collecting data directly from participants. For instance, we are able to measure how many people stayed in the study simply by counting the number of returned questionnaires at the follow-up point.
What are the feasibility study’s objectives?
We are aiming to test seven different objectives:
- How willing participants are to enrol in the trial;
- Whether the eligibility criteria (the criteria that govern whether somebody can be included in the trial) give us a set of participants who are representative of the wider population of people with AF;
- Whether the participants will stay in the trial or drop out;
- Whether acupuncture and nutritional therapy are acceptable to people with AF;
- Whether the trial assessments and measurements are acceptable to the participants;
- The effect of the CardioSTAT® ambulatory ECG devices, which we will use to measure symptoms for a third of all participants;
- The feasibility of all the above objectives during a pandemic.
We will also collect and analyse data on safety; on the involvement of the acupuncturists and nutritional therapists who are giving treatments in the study; and on the involvement of the GP staff who are helping to recruit to the study.
How will the data be analysed?
The study will use mixed methods, meaning some quantitative data and some qualitative data will be collected. This means that we will use mathematical approaches to answer the objectives (above), but we will also ask participants to give some information in questionnaires. Also, some participants will be interviewed in addition to completing questionnaires, to find out more about the reasons for their responses.
By using mixed methods (quantitative and qualitative data analysis), the feasibility study can make recommendations for the design of a future large-scale trial that should improve our ability to carry out the large-scale trial successfully. For instance, if a large number of participants tell us that they do not like a particular aspect of the study assessments, the feasibility study may recommend that this is changed in the future trial.
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What are acupuncture and nutritional therapy?