Fibromyalgia Community Self-management FeasibilityTrial (FALCON)
Research type
Research Study
Full title
A feasibility Randomised Controlled Trial (RCT) of a Fibromyalgia Self-Management Programme (FSMP) in a community setting - (FALCON).
IRAS ID
246892
Contact name
Fiona Cramp
Contact email
Sponsor organisation
University of the West of England
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The aim of this work is to determine the practicality and acceptability of conducting a randomised controlled trial (RCT) to deliver the Fibromyalgia Self-Management Programme (FSMP) in the community to inform a future trial to test effectiveness. The feasibility study will explore; recruitment of participants from primary care; willingness of participants to be randomized; sample size calculation for a full RCT; selection of the primary outcome measure; follow-up rates; response rates to questionnaires; acceptability of the intervention and willingness of the clinicians to deliver the intervention in a community setting.
In this feasibility study adults identified from primary care, over 18 years and diagnosed with fibromyalgia (FM) will be invited to participate. Patient participants will be randomised to either usual care or referred to one of two local community sites where the 6-week FSMP intervention will be delivered by an occupational therapist and physiotherapist. A range of outcome data including fibromyalgia symptoms, quality of life and self-efficacy to manage their FM symptoms will be collected at baseline, six weeks and six months. To explore acceptability of the FSMP within a community setting a qualitative study, consisting of semi-structured interviews with patient participants and health professionals (physiotherapists and occupational therapists delivering the FSMP) will be nested within the feasibility RCT. Quantitative outcomes will be analysed descriptively and qualitative data will be analysed thematically to inform a future RCT.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
18/YH/0263
Date of REC Opinion
15 Aug 2018
REC opinion
Further Information Favourable Opinion