Evaluation of the effectiveness of professionally guided self care for consumers
| ISRCTN | ISRCTN59494484 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59494484 |
| Secondary identifying numbers | PCD/A2/27 |
- 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
Scientific
Department of Health Studies
Brunel University
Osterley Campus
Borough Road
Middlesex
TW7 5DU
United Kingdom
| Phone | +44 (0)20 8891 0121 x2527 |
|---|---|
| lorraine.desouza@brunel.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| 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 | 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 study start date | 01/09/1995 |
| Completion date | 30/04/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Department of Health Studies
Middlesex
TW7 5DU
United Kingdom
TW7 5DU
United Kingdom
Sponsor information
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
NHS National Physical and Complex Disabilities Programme (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
