Should general practitioners manage chronic fatigue syndrome? A controlled trial
| ISRCTN | ISRCTN78372534 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78372534 |
| Protocol serial number | PSI06-16 |
| Sponsor | Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK) |
| Funder | NHS Primary and Secondary Care Interface National Research and Development Programme (UK) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/02/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| 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
- United Kingdom
- England
Study participating centre
HU10 6NS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
