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ISRCTN
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ISRCTN74156610
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ClinicalTrials.gov identifier
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Public title
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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).
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Scientific title
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Acronym
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FINE
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Serial number at source
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G0200212
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Study hypothesis
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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?
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Chronic fatigue syndrome (CFS)
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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
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Anticipated start date
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21/06/2004
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Anticipated end date
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25/07/2008
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Status of trial
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Completed
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Patient information material
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Target number of participants
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360
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Interventions
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1. Pragmatic rehabilitation
2. Supportive listening
3. Treatment as usual by GP
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Primary outcome measure(s)
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The primary outcome measures will be patient-rated to avoid observer bias, and will be supplemented with an objective measure of the patient’s 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
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Secondary outcome measure(s)
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Secondary outcome measures will be:
1. A timed step-test to provide an objective measure of the patient’s exercise tolerance and cardiovascular fitness
2. Scores on the HAD to provide measures of depression and anxiety
3. A brief four-item sleep scale
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Sources of funding
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Medical Research Council (G0200212)
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Trial website
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Publications
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Study protocol on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16603058
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Contact name
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Dr
Alison
Wearden
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Address
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School of Psychological Sciences
Coupland 1 Building
Oxford Road
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City/town
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Manchester
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Zip/Postcode
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M13 9PL
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Country
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United Kingdom
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Tel
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+44 (0)161 275 2684
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Fax
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+44 (0)161 275 2588
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Email
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alison.wearden@psy.man.ac.uk
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Sponsor
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University of Manchester
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Address
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Research Office
Oxford Road
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City/town
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Manchester
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Zip/Postcode
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M13 9PL
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Country
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United Kingdom
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Tel
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+44 (0)161 275 2227
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Email
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john.rogers@manchester.ac.uk
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Date applied
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18/05/2001
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Last edited
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11/09/2007
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Date ISRCTN assigned
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18/05/2001
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