Condition category
Nervous System Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
01/08/2014
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

Prof Lorraine DeSouza

ORCID ID

Contact details

Department of Health Studies
Brunel University
Osterley Campus
Borough Road
Middlesex
TW7 5DU
United Kingdom
+44 (0)20 8891 0121 x2527
lorraine.desouza@brunel.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PCD/A2/27

Study information

Scientific title

Acronym

Study hypothesis

The overall aim of the project was to design and evaluate a consumer focused professionally guided self-care programme for a community sample of people with Multiple Sclerosis (MS).
The project had 3 stages, each with a different objective.
Stage 1: To obtain the views and priorities of people with MS to inform the design of the self-care programme.
Stage 2: To assess the efficacy of the self-care programme.
Stage 3: To obtain participant feedback in order to inform the refinement of the programme.

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

Other

Trial type

Other

Patient information sheet

Condition

Multiple sclerosis (MS)

Intervention

Stage 2: (Single blind randomised controlled trial). The self-care programme primarily comprised discussion with a health care professional (physiotherapist) of self-care strategies, supported by an information booklet developed for the study and based on priorities identified in Stage 1. The discussion focused on individual's needs rather than on covering all the information in the booklet. Participants were encouraged to change some aspect of their self-care routine, following discussion, although they were not required to do so. The discussion was conducted on 2 occasions, either one-to-one or in a group setting. Sessions lasted between 1 and 2 hours and were organised at times and places which were convenient to each individual.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. The results from the Delphi survey were the outcome measures in stage 1.
2. The outcome measures in stage 2 included the Barthel Index, Functional Mobility Assessment Scale, Cope Scale, SF-36, Standard Day Dependency Record, and the Inventory of Avoidable Complications in MS.
3. The outcome measure in stage 3 was the feedback questionnaire.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/1995

Overall trial end date

30/04/1999

Reason abandoned

Eligibility

Participant inclusion criteria

Participants were recruited through MS voluntary organisations. The only selection criterion was that the MS diagnosis was confirmed by GPs. In stage 1 the panel comprised 200 volunteers, living throughout the UK, of whom 136 responded to the survey (68%). In stage 2 the panel comprised 278 volunteers, living in and around London, of whom 183 were randomised and 169 (92%) completed the study. In stage 3, 73 people from the intervention group in stage 2 provided feedback.
The randomised controlled trial was conducted at the Centre for Research in Rehabilitation at Brunel University in London.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

183

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/09/1995

Recruitment end date

30/04/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Health Studies
Middlesex
TW7 5DU
United Kingdom

Sponsor information

Organisation

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)

Sponsor details

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

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS National Physical and Complex Disabilities Programme (UK)

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

1. 2000 results in http://www.ncbi.nlm.nih.gov/pubmed/10688346
2. 2002 results in http://www.ncbi.nlm.nih.gov/pubmed/11911510

Publication citations

  1. Results

    O'Hara L, Cadbury H, De SL, Ide L, Evaluation of the effectiveness of professionally guided self-care for people with multiple sclerosis living in the community: a randomized controlled trial., Clin Rehabil, 2002, 16, 2, 119-128.

  2. O'Hara L, De Souza LH, Ide L, A Delphi study of self-care in a community population of people with multiple sclerosis., Clin Rehabil, 2000, 14, 1, 62-71.

Additional files

Editorial Notes