| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN74156610 |
| Date ISRCTN assigned | 18/05/2001 |
| Local reference number(s) | G0200212 |
| 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 |
| Disease/condition/study domain | Chronic fatigue syndrome (CFS) |
| 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? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| 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 |
| Patient information material |
|
| Anticipated start date | 21/06/2004 |
| Anticipated end date | 25/07/2008 |
| Status of trial | Ongoing |
| 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 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 |
| Secondary outcome measure(s) | 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 |
| Publications | Study protocol on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16603058 |
| Sources of funding | Medical Research Council (G0200212) |
| Sponsor name | University of Manchester |
| Sponsor details | Research Office
Oxford Road
Manchester
United Kingdom
M13 9PL |
| Sponsor telephone | +44 (0)161 275 2227 |
| Sponsor email | john.rogers@manchester.ac.uk |
| Contact name | Dr Alison Wearden |
| Contact details | School of Psychological Sciences
Coupland 1 Building
Oxford Road
Manchester
United Kingdom
M13 9PL |
| Contact telephone | +44 (0)161 275 2684 |
| Contact fax | +44 (0)161 275 2588 |
| Contact email | alison.wearden@psy.man.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN74156610 |
| Date last extracted from ISRCTN register | 17/04/2008 |
