Contact information
Type
Scientific
Primary contact
Miss Liz Watson
ORCID ID
Contact details
St Lukes Hospital
Little Horton Lane
Bradford
BD5 0NA
United Kingdom
+44 (0)1274 365249
liz.watson@bradfordhospitals.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0050171956
Study information
Scientific title
Feasibility study to compare self-help interventions of fatigue management in patients with multiple sclerosis: a randomised controlled trial
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
Increased ability to cope with fatigue scale and Hospital Anxiety and Depression Scale (HADS).
Secondary outcome measures
Not provided at time of registration
Overall trial start date
16/09/2005
Overall trial end date
31/05/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
32 participants
Participant exclusion criteria
1. Patients who do not wish to be involved in the study
2. Patients receiving anti-fatigue medication (amantadine)
Recruitment start date
16/09/2005
Recruitment end date
31/05/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St lukes Hospital
Bradford
BD5 0NA
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Bradford Teaching Hospitals NHS Foundation Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Bradford Royal Infirmary
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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)
Publication list