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Early intervention in fatigue: a feasibility study
ISRCTN ISRCTN72645894
DOI 10.1186/ISRCTN72645894
ClinicalTrials.gov identifier
EudraCT number
Public title Early intervention in fatigue: a feasibility study
Scientific title
Acronym N/A
Serial number at source 11924
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
Lay summary Not provided at time of registration
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
Countries of recruitment United Kingdom
Disease/condition/study domain Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: Chronic fatigue syndrome (CFS)/ myalgic encephalomyelitis (ME)
Participants - 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
Participants - 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.
Anticipated start date 05/05/2012
Anticipated end date 31/10/2014
Status of trial Ongoing
Patient information material
Target number of participants Planned Sample Size: 100; UK Sample Size: 100
Interventions 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
Primary outcome measure(s) Recruitment, adherence and follow up. Timepoint(s): 3 and 6 months
Secondary outcome measure(s) Not provided at time of registration
Sources of funding NIHR (UK) Grant Codes: PB-PG-1010-23253
Trial website
Publications
Contact name Ms  Sarah  Horne
  Address Frenchay Hospital
Frenchay Hospital
Frenchay Park Road
  City/town Bristol
  Zip/Postcode BS16 1LE
  Country United Kingdom
  Email sarah.horne@nhs.net
Sponsor North Bristol NHS Trust (UK)
  Address Trust Headquarters
Beckspool Road
Frenchay
  City/town Bristol
  Zip/Postcode B16 1JE
  Country United Kingdom
Date applied 17/05/2013
Last edited 27/08/2013
Date ISRCTN assigned 17/05/2013
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