Evaluation of the effectiveness of professionally guided self care for consumers

ISRCTN	ISRCTN59494484
DOI	https://doi.org/10.1186/ISRCTN59494484
Protocol serial number	PCD/A2/27
Sponsor	Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Funder	NHS National Physical and Complex Disabilities Programme (UK)

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 01/08/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Lorraine DeSouza
Scientific

Department of Health Studies
Brunel University
Osterley Campus
Borough Road
Middlesex
TW7 5DU
United Kingdom

Phone	+44 (0)20 8891 0121 x2527
Email	lorraine.desouza@brunel.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/04/1999

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	183
Key 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.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/09/1995
Date of final enrolment	30/04/1999

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Health Studies

Middlesex
TW7 5DU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2000		Yes	No
Results article	results	01/03/2002		Yes	No