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
Secondary identifying numbers N0050171956
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

St Lukes Hospital
Little Horton Lane
Bradford
BD5 0NA
United Kingdom

Phone +44 (0)1274 365249
Email liz.watson@bradfordhospitals.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleFeasibility study to compare self-help interventions of fatigue management in patients with multiple sclerosis: a randomised controlled trial
Study objectivesDoes 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) studiedMultiple sclerosis (MS)
InterventionFeasibility study organised as a pilot randomised controlled trial comparing cognitive behaviour self help leaflet with standard fatigue advice leaflet.
Intervention typeOther
Primary outcome measureIncreased ability to cope with fatigue scale and Hospital Anxiety and Depression Scale (HADS).
Secondary outcome measuresNot provided at time of registration
Overall study start date16/09/2005
Completion date31/05/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants32 participants
Key inclusion criteriaAll 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 criteria1. Patients who do not wish to be involved in the study
2. Patients receiving anti-fatigue medication (amantadine)
Date of first enrolment16/09/2005
Date of final enrolment31/05/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

St lukes Hospital
Bradford
BD5 0NA
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Bradford Teaching Hospitals NHS Foundation Trust

No information available

Bradford Royal Infirmary

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

24/10/2016: No publications found, verifying study status with principal investigator