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
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
| 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 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(s) | Multicentre Research Ethics Committee (MREC), 19/01/2012, ref: 11/SW/0301 |
| 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 |
| 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 |
| Overall study end date | 31/10/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 100; UK Sample Size: 100 |
| Total final enrolment | 44 |
| 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 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
- England
- United Kingdom
Study participating centre
Frenchay Hospital
Bristol
BS16 1LE
United Kingdom
BS16 1LE
United Kingdom
Sponsor information
North Bristol NHS Trust (UK)
Hospital/treatment centre
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
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.
