Condition category
Nervous System Diseases
Date applied
17/05/2013
Date assigned
17/05/2013
Last edited
27/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Sarah Horne

ORCID ID

Contact details

Frenchay Hospital
Frenchay Hospital
Frenchay Park Road
Bristol
BS16 1LE
United Kingdom
sarah.horne@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11924

Study information

Scientific title

Acronym

Study hypothesis

The overall aim of this study is to investigate the feasibility and acceptability of conducting a randomised controlled trial (RCT) to investigate the efffectiveness and cost effectiveness of early intervention for Chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME) compared with standard medical care in primary care.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=11924

Ethics approval

Multicentre Research Ethics Committee (MREC) 11/SW/0301; first MREC approval date 19/01/2012

Study design

Randomised; Interventional; Design type: Prevention, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: Chronic fatigue syndrome (CFS)/ myalgic encephalomyelitis (ME)

Intervention

Early intervention for fatigue. The intervention is based on the principles of cognitive, behavioural and graded exercise and is delivered by a trained therapist as an individual face to face session with telelphone follow-up sessions. Follow up length: 6 month(s); Study entry: single randomisation only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Recruitment, adherence and follow up. Timepoint(s): 3 and 6 months

Secondary outcome measures

Not provided at time of registration

Overall trial start date

05/05/2012

Overall trial end date

31/10/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients (over 18) presenting with an unexplained primary complaint of fatigue, as a new episode, lasting more than one month but less than four.
2. Patient has given written informed consent
3.The participant has a Chalder Fatigue score >4 (screened by trial manager); target gender: male and female; lower age limit: 18 no age limit or unit specified

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 100; UK Sample Size: 100

Participant exclusion criteria

1. Patients where fatigue is due to another cause. This means that GPs will not refer patients with an active illness such as cancer, liver cirrhosis etc.

Recruitment start date

05/05/2012

Recruitment end date

31/10/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Frenchay Hospital
Bristol
BS16 1LE
United Kingdom

Sponsor information

Organisation

North Bristol NHS Trust (UK)

Sponsor details

Trust Headquarters
Beckspool Road
Frenchay
Bristol
B16 1JE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR (UK) Grant Codes: PB-PG-1010-23253

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes