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A randomised controlled trial of nurse facilitated self-help treatment for patients in primary care with chronic fatigue syndrome. The FINE trial (Fatigue Intervention by Nurses Evaluation).
ISRCTN ISRCTN74156610
DOI 10.1186/ISRCTN74156610
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised controlled trial of nurse facilitated self-help treatment for patients in primary care with chronic fatigue syndrome. The FINE trial (Fatigue Intervention by Nurses Evaluation).
Scientific title
Acronym FINE
Serial number at source G0200212
Study hypothesis 1. Is pragmatic rehabilitation, delivered at home by nurses to CFS patients recruited from primary care, a clinically effective intervention in terms of reduced disability and fatigue when compared with treatment as usual delivered through the primary care team?
2. Is pragmatic rehabilitation, delivered at home by nurses to CFS patients recruited from primary care, a cost effective intervention when compared with treatment as usual delivered through the primary care team?
3. Is supportive listening, delivered at home by nurses to CFS patients recruited from primary care, a clinically effective intervention in terms of reduced disability and fatigue when compared with treatment as usual delivered through the primary care team?
4. Is supportive listening, delivered at home by nurses to CFS patients recruited from primary care, a cost effective intervention when compared with treatment as usual delivered through the primary care team?

Can we demonstrate that the active component of pragmatic rehabilitation operates in addition to a non-specific treatment effect due to contact with a supportive therapist?
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Chronic fatigue syndrome (CFS)
Participants - inclusion criteria Patients 18 and over, who fulfil the Oxford criteria for CFS (Sharpe et al. 1991) [Prior to Feb'2005 the criteria was the Fukuda criteria], and who have a principal complaint of fatigue. Patients must score 4 or more on the 11-item Chalder fatigue scale, and 70% or less on the SF-36 physical functioning scale.
Participants - exclusion criteria 1. Patients whose fatigue is explained by any active medial condition
2. Patients with schizophrenia, bipolar disorder, dementia, eating disorder, substance abuse, morbid obesity
3. Patients with current suicidal ideation
4. Patients with anti-social, borderline or paranoid personality disorder
5. Patients who cannot read or write English sufficiently well to participate
6. Patients who are incapable of giving informed consent
Anticipated start date 21/06/2004
Anticipated end date 25/07/2008
Status of trial Completed
Patient information material
Target number of participants 360
Interventions 1. Pragmatic rehabilitation
2. Supportive listening
3. Treatment as usual by GP
Primary outcome measure(s) The primary outcome measures will be patient-rated to avoid observer bias, and will be supplemented with an objective measure of the patientís exercise tolerance. These will be:
1. Score on the physical functioning scale of the SF-36
2. Cost-effectiveness using the Euroquol
3. The score on the 11-item Fatigue Scale
Secondary outcome measure(s) Secondary outcome measures will be:
1. A timed step-test to provide an objective measure of the patientís exercise tolerance and cardiovascular fitness
2. Scores on the HAD to provide measures of depression and anxiety
3. A brief four-item sleep scale
Sources of funding Medical Research Council (MRC) (UK) (G0200212)
Trial website
Publications 1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16603058
2. 2010 results of qualitative study in http://www.ncbi.nlm.nih.gov/pubmed/20178588
3. 2010 results of randomised controlled trial in http://www.ncbi.nlm.nih.gov/pubmed/20418251
4. 2011 results of patient engagement in http://www.ncbi.nlm.nih.gov/pubmed/21457596
5. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22192566
6. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22844025
7. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23327355
Contact name Dr  Alison  Wearden
  Address School of Psychological Sciences
Coupland 1 Building
Oxford Road
  City/town Manchester
  Zip/Postcode M13 9PL
  Country United Kingdom
  Tel +44 (0)161 275 2684
  Fax +44 (0)161 275 2588
  Email
Sponsor University of Manchester (UK)
  Address Research Office
Oxford Road
  City/town Manchester
  Zip/Postcode M13 9PL
  Country United Kingdom
  Tel +44 (0)161 275 2227
  Email john.rogers@manchester.ac.uk
Date applied 18/05/2001
Last edited 22/02/2013
Date ISRCTN assigned 18/05/2001
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