A randomised controlled trial of nurse facilitated self-help treatment for patients in primary care with chronic fatigue syndrome
| ISRCTN | ISRCTN74156610 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74156610 |
| Secondary identifying numbers | G0200212 |
- Submission date
- 18/05/2001
- Registration date
- 18/05/2001
- Last edited
- 29/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Alison Wearden
Scientific
Scientific
School of Psychological Sciences
Coupland 1 Building
Oxford Road
Manchester
M13 9PL
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific 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) |
| Study acronym | FINE |
| 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? |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Chronic fatigue syndrome (CFS) |
| Intervention | 1. Pragmatic rehabilitation 2. Supportive listening 3. Treatment as usual by GP |
| Intervention type | Other |
| Primary outcome measure | The primary outcome measures will be patient-rated to avoid observer bias, and will be supplemented with an objective measure of the patients 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 measures | 1. A timed step-test to provide an objective measure of the patients exercise tolerance and cardiovascular fitness 2. Scores on the HAD to provide measures of depression and anxiety 3. A brief four-item sleep scale |
| Overall study start date | 21/06/2004 |
| Overall study end date | 25/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 360 |
| Participant 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. |
| Participant 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 |
| Recruitment start date | 21/06/2004 |
| Recruitment end date | 25/07/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Manchester
Manchester
M13 9PL
United Kingdom
M13 9PL
United Kingdom
Sponsor information
University of Manchester (UK)
University/education
University/education
Research Office
Oxford Road
Manchester
M13 9PL
England
United Kingdom
| Phone | +44 (0)161 275 2227 |
|---|---|
| john.rogers@manchester.ac.uk | |
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK) (G0200212)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 07/04/2006 | Yes | No | |
| Results article | results of qualitative study | 23/02/2010 | Yes | No | |
| Results article | results of randomised controlled trial | 23/04/2010 | Yes | No | |
| Results article | results of patient engagement | 01/04/2011 | Yes | No | |
| Results article | results | 22/12/2011 | Yes | No | |
| Results article | results | 01/09/2012 | Yes | No | |
| Results article | results | 18/01/2013 | Yes | No | |
| Results article | results | 14/12/2015 | Yes | No |
Editorial Notes
29/06/2016: Publication reference added.
