Fatigue Intervention by Nurses Evaluation – The FINE Trial. A randomised controlled trial of nurse led self-help treatment for patients in primary care with chronic fatigue syndrome: study protocol. [ISRCTN74156610]
1 School of Psychological Sciences, University of Manchester, Manchester, M13 9PL, UK
2 School of Population, Community and Behavioural Sciences, University of Liverpool, Liverpool, L69 3GB, UK
3 Division of Primary Care, Rusholme Academic Unit, University of Manchester, Manchester, M14 5NP, UK
4 Department of Psychiatry, Queens Medical Centre, University of Nottingham, Nottingham, NG7 2UH, UK
5 Division of Psychiatry, University of Liverpool, Liverpool, L69 3GA, UK
6 Division of Epidemiology and Health Sciences, University of Manchester, Manchester, M13 9PT, UK
7 Centre for Health Economics, University of York, York, YO10 5DD, UK
8 School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, M13 9PL, UK
9 Infectious Diseases Unit, Royal Liverpool University Hospital, Liverpool, L7 8XP UK
BMC Medicine 2006, 4:9 doi:10.1186/1741-7015-4-9Published: 7 April 2006
Chronic fatigue syndrome, also known as ME (CFS/ME), is a condition characterised primarily by severe, disabling fatigue, of unknown origin, which has a poor prognosis and serious personal and economic consequences. Evidence for the effectiveness of any treatment for CFS/ME in primary care, where most patients are seen, is sparse. Recently, a brief, pragmatic treatment for CFS/ME, based on a physiological dysregulation model of the condition, was shown to be successful in improving fatigue and physical functioning in patients in secondary care. The treatment involves providing patients with a readily understandable explanation of their symptoms, from which flows the rationale for a graded rehabilitative plan, developed collaboratively with the therapist. The present trial will test the effectiveness and cost-effectiveness of pragmatic rehabilitation when delivered by specially trained general nurses in primary care. We selected a client-centred counselling intervention, called supportive listening, as a comparison treatment. Counselling has been shown to be as effective as cognitive behaviour therapy for treating fatigue in primary care, is more readily available, and controls for supportive therapist contact time. Our control condition is treatment as usual by the general practitioner (GP).
Methods and design
This study protocol describes the design of an ongoing, single-blind, pragmatic randomized controlled trial of a brief (18 week) self-help treatment, pragmatic rehabilitation, delivered by specially trained nurse-therapists in patients' homes, compared with nurse-therapist delivered supportive listening and treatment as usual by the GP. An economic evaluation, taking a societal viewpoint, is being carried out alongside the clinical trial. Three adult general nurses were trained over a six month period to deliver the two interventions. Patients aged over 18 and fulfilling the Oxford criteria for CFS are assessed at baseline, after the intervention, and again one year later. Primary outcomes are self-reported physical functioning and fatigue at one year, and will be analysed on an intention-to-treat basis. A qualitative study will examine the interventions' mechanisms of change, and also GPs' drivers and barriers towards referral.