Should general practitioners manage chronic fatigue syndrome? A controlled trial
| ISRCTN | ISRCTN78372534 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78372534 |
| Secondary identifying numbers | PSI06-16 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 29/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Peter Campion
Scientific
Scientific
Department of Public Health and Primary Care
University of Hull
College House
East Riding Campus
Willerby
HU10 6NS
United Kingdom
| abc@email.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Other |
| Scientific title | Should general practitioners manage chronic fatigue syndrome? A controlled trial |
| Study objectives | A pragmatic randomised controlled trial was conducted in general practice to test the hypotheses that general practitioners could (a) diagnose and (b) treat patients with the Chronic Fatigue Syndrome (CFS). |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Other symptoms and general pathology |
| Intervention | The intervention we attempted to introduce was a form of brief behavioural therapy, offered to GPs as a management package. Control practices were invited to manage their patients as usual, which in many cases included referral to secondary care. |
| Intervention type | Other |
| Primary outcome measure | The study suffered from both poor recruitment and high drop out. However, we were able to show that this intervention had no effect on the illness of the patients enrolled, and that patients with CFS remained highly disabled over the 12 month study period, whatever their treatment. The study suggests that general practitioners can diagnose CFS, but under the conditions of this study were unable to effectively treat the condition. This accords with the recent Royal Colleges' report, that early recognition in primary care is important, but that the only evidence for effective treatment thus far has come from specialist units. General practitioners do not yet generally have the skills nor the time to provide effective treatment programmes for CFS. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/04/1995 |
| Completion date | 01/02/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | General Practices willing to take part. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/04/1995 |
| Date of final enrolment | 01/02/1998 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Public Health and Primary Care
Willerby
HU10 6NS
United Kingdom
HU10 6NS
United Kingdom
Sponsor information
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
NHS Primary and Secondary Care Interface National Research and Development Programme (UK)
No information available
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? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2002 | 29/10/2019 | Yes | No |
Editorial Notes
29/10/2019: added pub.
