Early intervention in fatigue: a feasibility study

ISRCTN	ISRCTN72645894
DOI	https://doi.org/10.1186/ISRCTN72645894
Secondary identifying numbers	11924

Submission date: 17/05/2013
Registration date: 17/05/2013
Last edited: 26/05/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Sarah Horne
Scientific

Specialist CFS/ME Occupational Therapist
Cossham Hospital
Kingswood
Bristol
BS15 1LF
United Kingdom

Phone	+44 (0)117 4145792
Email	Sarah.Horne@nbt.nhs.uk

Study information

Study design	Randomised; Interventional; Design type: Prevention, Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Early intervention in fatigue: a feasibility study
Study objectives	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.
Ethics approval(s)	Multicentre Research Ethics Committee (MREC), 19/01/2012, ref: 11/SW/0301
Health condition(s) or problem(s) studied	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
Primary outcome measure	Recruitment, adherence and follow up. Timepoint(s): 3 and 6 months
Secondary outcome measures	Not provided at time of registration
Overall study start date	05/05/2012
Completion date	31/10/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target number of participants	Planned Sample Size: 100; UK Sample Size: 100
Total final enrolment	44
Key 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
Key exclusion criteria	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.
Date of first enrolment	05/05/2012
Date of final enrolment	31/10/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Frenchay Hospital

Bristol
BS16 1LE
United Kingdom

Sponsor information

North Bristol NHS Trust (UK)
Hospital/treatment centre

Trust Headquarters
Beckspool Road
Frenchay
Bristol
B16 1JE
England
United Kingdom

"ROR"	https://ror.org/036x6gt55

Funders

Funder type

Government

National Institute for Health Research (Grant Codes: PB-PG-1010-23253)
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

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?
Basic results		27/03/2019	27/03/2019	No	No
Results article	results	12/05/2020	26/05/2020	Yes	No

Additional files

ISRCTN72645894_BasicResults_27Mar19.pdf: Uploaded 27/03/2019

Editorial Notes

26/05/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
27/03/2019: The basic results of this trial have been uploaded as an additional file.
21/01/2019: The contact details for the scientific contact have been updated.
16/01/2017: No publications found, verifying study status with principal investigator.