P179 A feasibility randomised controlled trial of a fibromyalgia self-management programme in a community setting with a nested qualitative study
Authors: Pearson Jennifer , Coggins Jessica , Derham Sandi , Russell Julie , Walsh Nicola , Lenguerrand Erik , Palmer Shea , Cramp Fiona 
Published: April 2022

Background/Aims

Fibromyalgia (FM) is a complex long-term condition affecting over 5% of the UK population. FM symptoms include widespread pain, fatigue, sleep problems, stiffness, cognitive dysfunction and psychological distress. The condition is associated with high levels of disability, frequent use of healthcare resources and loss of workdays. Current guidelines for the treatment of FM recommend non-pharmacological interventions, including cognitive behaviour therapy, aerobic exercise, warm water therapy, relaxation, and patient education. A typical patient goal is to develop the knowledge and skills needed to self-manage their condition independently. Our Fibromyalgia Self-Management Programme (FSMP) comprises six 2.5-hour sessions over six consecutive weeks and includes education about fibromyalgia, sleep hygiene, goal setting, pacing, and dietary advice. To date, the FSMP has been co-delivered by a multidisciplinary team within a secondary care service. However, delivery in the community may help improve the accessibility of the programme to people with FM. Therefore, this feasibility study aimed to determine the practicality and acceptability of conducting a future definitive randomised controlled trial (RCT) of the FSMP in a community setting.

Methods

An exploratory, parallel-arm, one-to-one, RCT design was used. Participants were recruited from general practices across South West England, and the FSMP was co-delivered by physiotherapists and occupational therapists across two community sites. To determine the outcome measures for a future definitive trial, several outcomes were tested. All clinical outcome measures were patient-reported and collected at baseline, six weeks and six months. Semi-structured interviews were conducted with patient participants, occupational therapists and physiotherapists to explore the acceptability and feasibility of delivering the FSMP in a community setting.

Results

Between April and August 2019, 20 General Practices across two sites in SW England invited 1414 patients with an FM diagnosis to participate in the study. A total of 74 participants were randomised to the FSMP intervention (n = 38) or control arm (n = 36). Attrition from the trial was 42% (31/74) at six months. A large proportion of those randomised to the intervention arm (34%, 13/38) failed to attend any sessions, with six of the 13 formally withdrawing before the intervention commenced. The proportion of missing values was small for each of the outcome measures. For the nested qualitative study, 13 patient participants and four therapists were interviewed. Three overarching themes emerged: (1) barriers and facilitators to attending the FSMP; (2) FSMP content, delivery and supporting documentation; and (3) trial processes.

Conclusion

It is feasible to recruit people with FM from primary care to participate in an RCT testing the clinical and cost-effectiveness of the FSMP delivered in a community setting. However, improvement in attrition and engagement with the intervention is needed.

Disclosure

J. Pearson: None. J. Coggins: None. S. Derham: None. J. Russell: None. N. Walsh: None. E. Lenguerrand: Other; Erik Lenguerrand and his institution are receiving funding from Ceramtec to conduct an orthopaedic research project that has no relationship to the study presented here. S. Palmer: None. F. Cramp: None.