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

Department of Public Health and Primary Care
University of Hull
College House
East Riding Campus
Willerby
HU10 6NS
United Kingdom

Email abc@email.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeOther
Scientific titleShould general practitioners manage chronic fatigue syndrome? A controlled trial
Study objectivesA 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) studiedOther symptoms and general pathology
InterventionThe 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 typeOther
Primary outcome measureThe 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 measuresNot provided at time of registration
Overall study start date01/04/1995
Completion date01/02/1998

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaGeneral Practices willing to take part.
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/04/1995
Date of final enrolment01/02/1998

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Public Health and Primary Care
Willerby
HU10 6NS
United Kingdom

Sponsor information

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.