Topic: Musculoskeletal
Conditions
Interventions
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
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 wil
Sponsors
University Hospitals Bristol NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed