Early intervention in fatigue: a feasibility study
| ISRCTN | ISRCTN72645894 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72645894 |
| Protocol serial number | 11924 |
| Sponsor | North Bristol NHS Trust (UK) |
| Funder | National Institute for Health Research (Grant Codes: PB-PG-1010-23253) |
- 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
Scientific
Specialist CFS/ME Occupational Therapist
Cossham Hospital
Kingswood
Bristol
BS15 1LF
United Kingdom
| Phone | +44 (0)117 4145792 |
|---|---|
| Sarah.Horne@nbt.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Prevention, Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | 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(s) |
Recruitment, adherence and follow up. Timepoint(s): 3 and 6 months |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/10/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Frenchay Hospital
Bristol
BS16 1LE
United Kingdom
BS16 1LE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 12/05/2020 | 26/05/2020 | Yes | No |
| Basic results | 27/03/2019 | 27/03/2019 | No | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
