Reducing Arthritis Fatigue - clinical Teams using cognitive behavioural approaches (RAFT)
| ISRCTN | ISRCTN52709998 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52709998 |
| Secondary identifying numbers | 15475 |
- Submission date
- 08/11/2013
- Registration date
- 08/11/2013
- Last edited
- 30/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Rheumatoid Arthritis (RA) is a lifelong condition leading to joint damage and disability. Up to 70% of people with RA are tired and experience overwhelming and unmanageable physical exhaustion or 'wipe-out'. Physical, mental and emotional tiredness disturbs social and work activities, concentration and memory, causing frustration and tearfulness. RA fatigue may be caused by combinations of inflammation, pain, disability, depression, stress, poor sleep, and behaviour. Many patients are unable to manage their fatigue and report that clinical staff don't help. Recent research has highlighted the critical role of patient self-management in persistent RA fatigue and the need for self-management methods. Cognitive-behavioural therapy (CBT) helps patients make links between beliefs, feelings, behaviours and symptoms in order to help them alter their behaviour. The key self-management skills of problem-solving and goal-setting can be enhanced by sharing the learning process in groups. Additionally, using other patients as role models can help increase self-belief and confidence. We recently developed and studied a psychologist-led CBT approach course to help people manage RA fatigue. The intervention proved to be effective in improving fatigue impact, severity and coping, mood, sleep and disability. We understand that few rheumatology teams have psychologists and have now designed a more practical method suitable for delivery by rheumatology health professionals who are not CBT therapists, using a detailed manual. This study aims to find out how well this method works and the cost/savings to the NHS in comparison to usual fatigue management.
Who can participate?
Patients with confirmed RA and severe fatigue that they consider a persistent problem.
What does the study involve?
Patients who agree to join the trial will be assigned randomly to either RAFT (CBT intervention) or to usual care. Patients in both groups will receive the Arthritis Research UK fatigue self-management booklet, which is the most recent information available. We will look for change in fatigue impact at 6 months. We will also measure fatigue severity and coping, pain, disability, mood, sleep, quality of life, and return to valued activities (e.g., hobbies). To evaluate the cost of this intervention to the NHS we will ask patients to record their use of health services in daily diaries, and will ask staff to record time spent on this intervention. To find out how long any effects will last, we will follow patients for 2 years, which may provide helpful information on whether (and when) a booster session is needed. We will interview staff to understand how easy or hard it was to learn CBT approaches and whether the new skills have influenced how they work with patients in their wider clinical practice (and if so, how).
What are the possible risks and benefits of participating?
We do not expect any side effects from receiving the booklet, taking part in the workshop sessions, or completing the questionnaires. However, if looking at the booklet or attending the workshops causes participants any concerns they will be referred to the local rheumatology clinical team for further support. All participants will receive information that may help them to manage their fatigue and improve their day-to-day life with RA. We cannot guarantee this, but taking part and completing the questionnaires will help us test this formally. The results may help future patients with arthritis and fatigue.
Where is the study run from?
The study is run from the following sites in the UK:
1. University of Bristol & Bristol Royal Infirmary
2. Cardiff University & University Hospital Wales
3. North Bristol NHS Trust, Southmead Hospital
4. Weston Area Health NHS Trust, Weston Hospital
5. S Devon NHS Foundation Trust, Torbay Hospital
6. Poole NHS Foundation Trust, Poole Hospital
7. Ashford & St Peters' NHS Trust, St Peter's Hospital
When is the study starting and how long is it expected to run for?
Recruitment is due to begin in February 2014 and end in September 2015. Follow-up is expected to be complete by October 2017.
Who is funding the study?
The study is funded by the National Institute for Health Research (NIHR), UK.
Who is the main contact?
Dr Zoe Plummer
Zoe.Plummer@uwe.ac.uk
Contact information
Scientific
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
| sarah.hewlett@uwe.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Not specified, Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact Dr Zoe Plummer, Trial Manager at Zoe.Plummer@uwe.ac.uk or 0117 342 3276 to request a patient information sheet. |
| Scientific title | Reducing Arthritis Fatigue - clinical Teams using cognitive behavioural approaches (RAFT): a multi-centre randomised controlled trial |
| Study acronym | RAFT |
| Study hypothesis | We hypothesise that there will be a clinically important difference in the impact of fatigue between patients participating in a group cognitive-behavioural self-management course for RA fatigue delivered by the clinical rheumatology team using a detailed manual, in addition to usual care; compared to patients receiving usual care, which includes written fatigue self-management information. More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=15475 |
| Ethics approval(s) | 13-EE-0310; First MREC approval date 25/09/2013 |
| Condition | Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Inflammatory Arthritis |
| Intervention | Each of the seven centres will recruit four cohorts of patients over a two-year period. For every cohort in every centre, 10-16 interested and potentially eligible patients will be invited to attend a 1 hour baseline visit for written consent, baseline assessments and usual care. When all baseline visits are complete for the current cohort, the Trial Manager in Bristol will obtain randomizations from the Bristol Randomized Trials Collaboration. Randomization is stratified by centre; and within centres stratified by cohort number (1-4). Allocation will be 1:1 but in the event of an odd number, the CB intervention arm will receive an additional patient. The local research nurse will inform patients of their allocation and will confirm CB course dates and times with those receiving the intervention. The intervention is a CB approach self-management programme for fatigue. Patients attend 6 2-hour sessions (weeks 1-6) and a 1 hour consolidation session (week 14). Sessions are co-facilitated by a pair of tutors who facilitate group discussion in the first hour and each take half the group for goal setting in the second hour. Tutors are trained in the delivery of each session and work from a standardised RAFT programme manual that contains instructions, key points to be drawn from patients, sample conversations, suggested timings, materials provided and how they are to be used. Sessions cover the following topics: fatigue, sleep and rest, stress and relaxation, assertiveness, communicating needs, reviewing self-help tools and dealing with setbacks. Outcomes will be collected for all randomised patients at Weeks 0 (baseline visit), 6, 10, 18, 26, 52, 78, and 104 using validated RA measures. |
| Intervention type | Other |
| Primary outcome measure | Fatigue impact at 26 weeks measured by a single numerical rating scale (NRS) that has been developed for and validated in Rheumatoid Arthritis: The Bristol RA Fatigue NRS Impact (BRAFNRS Impact) |
| Secondary outcome measures | 1. Acceptability of intervention and control; Timepoint(s): 26 weeks 2. Cost-effectiveness (work, personal, social and NHS costs); Timepoint(s): 0, 6, 26, 52, 78, 104 weeks 3. Fatigue severity, coping; Timepoint(s): 0, 6, 10, 18, 26, 52, 78, 104 weeks 4. Helplessness, self-efficacy; Timepoint(s): 0, 6, 26, 52, 78, 104 weeks 5. Pain, disability, quality of life, sleep, mood, valued life activities, disease activity; Timepoint(s): 0, 6, 26, 52, 78, 104 weeks |
| Overall study start date | 01/02/2014 |
| Overall study end date | 05/04/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 333; UK Sample Size: 333 |
| Total final enrolment | 333 |
| Participant inclusion criteria | Participants may enter the study if ALL of the following apply: 1. Diagnosis of RA 2. Fatigue measured by severity on the Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scales (BRAF NRS) > 6/10 3. More than 1 episode of fatigue |
| Participant exclusion criteria | Participants may not enter the study if ANY of the following apply: 1. Change in major RA medication in last 16 weeks 2. Increase in oral or ANY i/m or i/v glucocorticoids in last 6 weeks 3. Insufficient English to participate in group discussions 4. Lack of capacity for informed consent |
| Recruitment start date | 01/02/2014 |
| Recruitment end date | 01/09/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
BS2 8HW
United Kingdom
Sponsor information
Hospital/treatment centre
Education Centre, Upper Maudlin Street
Bristol
BS2 8AE
England
United Kingdom
"ROR" |
https://ror.org/04nm1cv11 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/05/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of the clinical, economic and qualitative results are planned for high-impact peer-reviewed journals by May 2019. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Professor Sarah Hewlett on Sarah.Hewlett@uwe.ac.uk. Access to the available anonymised data may be granted following review. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 06/08/2015 | Yes | No | |
| Results article | results | 01/04/2019 | 24/04/2019 | Yes | No |
| Results article | results | 01/10/2019 | 14/10/2019 | Yes | No |
| Results article | qualitative results | 27/08/2019 | 22/10/2019 | Yes | No |
| Results article | results | 01/04/2019 | 30/01/2020 | Yes | No |
Editorial Notes
30/01/2020: Publication reference added.
22/10/2019: Publication reference added.
14/10/2019: Publication reference added.
24/04/2019: The following changes were made:
1. Publication reference added.
2. The total final enrolment was added from the reference.
12/11/2018: The following changes were made:
1. The publication and dissemination plan was added.
2. The intention to publish date was added.
3. The participant level data was added.
19/10/2018: The following changes were made:
1. Target number of participants updated from "Planned Sample Size: 300; UK Sample Size: 300" to "Planned Sample Size: 333; UK Sample Size: 333".
2. The total target enrolment was updated from 300 to 333.
3. The overall trial end date was updated from 30/10/2017 to 05/04/2018.
