Self-management of fatigue in rheumatoid arthritis
ISRCTN | ISRCTN32195100 |
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DOI | https://doi.org/10.1186/ISRCTN32195100 |
Secondary identifying numbers | N/A |
- Submission date
- 16/11/2006
- Registration date
- 01/02/2007
- Last edited
- 09/05/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sarah Hewlett
Scientific
Scientific
Academic Rheumatology
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
Phone | +44 (0)117 928 2903 |
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Sarah.Hewlett@uwe.ac.uk |
Study information
Study design | Aim 1: Non-blinded, randomised controlled intervention study, with analysis blind to group allocation Aim 2: Nested qualitative study within the complex intervention arm |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study objectives | Rheumatoid arthritis, an autoimmune disease causing synovitis in multiple small joints. It has varying levels of inflammatory activity that progressively lead to joint destruction, disability, fatigue, pain and potential psychological sequalae. Self-management is key, but fatigue is rarely addressed and patients rate it as important and overwhelming, but do not know how to manage it. Aim 1: To test the null hypothesis that there will be no difference in change in the impact of fatigue, between Rheumatoid Arthritis (RA) patients participating in a multi-disciplinary, Cognitive Behavioural Therapy (CBT)-based fatigue self-management programme, compared to those receiving standard information alone Aim 2: To explore the contribution of the different components of the complex multi-disciplinary CBT package |
Ethics approval(s) | Approval received from the North Somerset and South Bristol REC on the 11th January 2007 (ref: 06/Q2006/149). |
Health condition(s) or problem(s) studied | Rheumatoid arthritis |
Intervention | The CBT intervention programme will be delivered weekly over six weeks, to groups of seven to ten patients, in sessions lasting two hours. The course will be led by a clinical psychologist, supported by a nurse, physiotherapist, Occupational Therapist and psychology research associate. Three to four facilitators will attend all sessions to ensure quality CBT and team working, to allow one-to-one goal setting and to ensure patients can receive adequate individual support if issues are discussed that have particular personal implications for them (e.g., effect of fatigue on relationships). Sessions will be supported with handouts, and some work at home in between the weekly sessions is a necessary part of the course, e.g., diary keeping and achieving goals. The first session will establish: 1. The groups ground rules (e.g., commitment and confidentiality) 2. The purpose and expectations of the course (e.g., management not cure) 3. Defining fatigue and its consequences 4. Differentiating between disease activity flares, pain, stiffness and fatigue Goal-setting will be introduced in the second session and will form a feature of every session. Sessions two to six will cover: 1. Energy management (planning, pacing and prioritising activities) 2. Activity cycling 3. Assertiveness 4. Recuperation or restoration of energy 5. Sleep 6. Negative self-talk 7. Graded activity 8. Passivity 9. Reconditioning and increasing physical activity 10. Links between fatigue, pain, stress, and depression 11. Relaxation 12. Management of stress 13. Avoiding and resolving setbacks Using the theoretical concepts of CBT, enhancing self-efficacy and achieving behaviour change, the course will use delivery methods such as role modelling, group work, addressing barriers, and positive reinforcements (e.g., using a pedometer as a visual aid to increase activity). Patients will be asked to keep a diary of events in order to help them manage their fatigue more effectively. Individually tailored goal-setting and contracting will be used to set individual, realistic goals, which are the means of transferring gains in managing the RA symptoms, into improved quality of life. The aim is that participants will achieve improved functioning in their domestic role and social life, which should in turn raise confidence and reduce emotional distress, including depression. The information-only arm will involve a single, one-hour group session of seven to ten participants, led by a rheumatology nurse (DP). It will use a largely information-giving approach, based on the two arc leaflets, allowing participants to share and discuss their current experiences and coping mechanisms. The clinical psychologist (NA) will provide support for the researcher before she delivers the control arm sessions (DP), to ensure a CBT approach is not utilised. The approach taken in the control arm will be to provide information and support the current coping strategies the participants already use, as it is not known whether or not a CBT approach is beneficial. |
Intervention type | Other |
Primary outcome measure | The primary outcome is change in fatigue impact and will be measured using the Multi-Dimensional Aspects of Fatigue scale (an RA-specific scale). |
Secondary outcome measures | The secondary outcomes are: 1. Perceived ability to cope with fatigue, which will be measured with a Visual Analogue Score (VAS) 2. Perceived fatigue severity (VAS) and physical status, which includes pain (VAS), disability (Health Assessment Questionnaire), and sleep (selected question from the Pittsburgh Sleep Quality Index) 3. Mood will be measured using the Hospital Anxiety and Depression Scale, and the Arthritis Helplessness Index 4. Quality of life will be measured using the RA Quality of Life Scale, a simple VAS for the personal impacts of fatigue (impact VAS) and disability (Personal Impact HAQ) The variables will be measured at all time-points (one, six, ten and 18 weeks). Process measures include number of sessions attended and self-efficacy (RA Self-Efficacy Scale), measured at all time-points. |
Overall study start date | 01/01/2007 |
Completion date | 01/09/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | n=88, ie 44 completed data sets per arm |
Key inclusion criteria | Aim 1: Patients will have a diagnosis of RA, and a score of more than seven for fatigue during the past week (Visual Analogue Scale [VAS] zero to ten) Aim 2: Patients attending the intervention arm, purposive sampling for wide range of variables |
Key exclusion criteria | Patients will be excluded if they have had a change in drugs likely to alter fatigue just prior to recruitment (within four months for Disease Modifying Anti-Rheumatic Drugs, within six weeks for intramuscular [i/m] glucocorticoids). |
Date of first enrolment | 01/01/2007 |
Date of final enrolment | 01/09/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Rheumatology
Bristol
BS2 8HW
United Kingdom
BS2 8HW
United Kingdom
Sponsor information
University of the West of England (UK)
University/education
University/education
c/o Professor Robin Means
Associate Dean
Faculty of Health and Social Care
Glenside Campus
Blackberry Hill
Bristol
BS16 1DD
England
United Kingdom
Robin.Means@uwe.ac.uk | |
Website | http://www.uwe.ac.uk/ |
https://ror.org/02nwg5t34 |
Funders
Funder type
Charity
Arthritis Research Campaign (UK) (grant)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/06/2011 | Yes | No |