Condition category
Nervous System Diseases
Date applied
17/05/2013
Date assigned
17/05/2013
Last edited
26/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Sarah Horne

ORCID ID

Contact details

Specialist CFS/ME Occupational Therapist
Cossham Hospital
Kingswood
Bristol
BS15 1LF
United Kingdom
+44 (0)117 4145792
Sarah.Horne@nbt.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11924

Study information

Scientific title

Early intervention in fatigue: a feasibility study

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.

Ethics approval

Multicentre Research Ethics Committee (MREC), 19/01/2012, ref: 11/SW/0301

Study design

Randomised; Interventional; Design type: Prevention, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant 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 measure

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 (if study stopped)

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

Total final enrolment

44

Participant 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.

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

National Institute for Health Research (Grant Codes: PB-PG-1010-23253)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

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

Basic results (scientific)

See additional file ISRCTN72645894_BasicResults_27Mar19.pdf

Publication list

2020 results in https://pubmed.ncbi.nlm.nih.gov/32426159/ (added 26/05/2020)

Publication citations

Additional files

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.