Feasibility study to compare self-help interventions of fatigue management in patients with multiple sclerosis: a randomised controlled trial
| ISRCTN | ISRCTN43867447 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43867447 |
| Protocol serial number | N0050171956 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funders | Bradford Teaching Hospitals NHS Foundation Trust, Bradford Royal Infirmary |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 24/10/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Liz Watson
Scientific
Scientific
St Lukes Hospital
Little Horton Lane
Bradford
BD5 0NA
United Kingdom
| Phone | +44 (0)1274 365249 |
|---|---|
| liz.watson@bradfordhospitals.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Feasibility study to compare self-help interventions of fatigue management in patients with multiple sclerosis: a randomised controlled trial |
| Study objectives | Does a self-help leaflet based on cognitive behaviour therapy principles improve patients ability to cope with symptoms of fatigue compared with the current leaflet. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Multiple sclerosis (MS) |
| Intervention | Feasibility study organised as a pilot randomised controlled trial comparing cognitive behaviour self help leaflet with standard fatigue advice leaflet. |
| Intervention type | Other |
| Primary outcome measure(s) |
Increased ability to cope with fatigue scale and Hospital Anxiety and Depression Scale (HADS). |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 32 |
| Key inclusion criteria | All patients will be identified from the MS Nurse's current caseload and will have identified fatigue as a significant symptom in the last 12 months. Inclusion Criteria: 1. Patients with Relapsing Remitting Multiple Sclerosis who are usually ambulant 2. Score of between 3-4 on the fatigue questionnaire 3. Over 18 years of age |
| Key exclusion criteria | 1. Patients who do not wish to be involved in the study 2. Patients receiving anti-fatigue medication (amantadine) |
| Date of first enrolment | 16/09/2005 |
| Date of final enrolment | 31/05/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
St lukes Hospital
Bradford
BD5 0NA
United Kingdom
BD5 0NA
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 |
Editorial Notes
24/10/2016: No publications found, verifying study status with principal investigator
