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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
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
-
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.
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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.