Condition category
Nervous System Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
24/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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