A randomised controlled trial investigating the clinical and cost-effectiveness of a patient self-management programme (SMP) for basic footcare in the elderly
ISRCTN | ISRCTN87471242 |
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DOI | https://doi.org/10.1186/ISRCTN87471242 |
Secondary identifying numbers | rctc94 441772 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 07/11/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Philip Helliwell
Scientific
Scientific
University of Leeds
Rheumatology & Rehabilitation Research Unit
36 Clarendon Road
Leeds
LS2 9NZ
United Kingdom
Phone | +44 (0)113 233 4952 |
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p.helliwell@leeds.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study objectives | To design and implement a new patient self-management programme for elderly patients seeking podiatry for basic foot problems. Access to NHS chiropody is often gained on "entitlement" rather than clinical need and in the elderly routine follow up is becoming a costly problem. The Department of Health has called on the profession to tackle this issue within the constraints of current funding levels. We have identified successful use of patient self-management programmes (SMP) for chronic low-grade conditions in other clinical fields and our key objective in this study is to develop a relevant programme for basic footcare in the elderly. We aim to test this, in terms of its clinical and cost-effectiveness, against conventional care in a (as yet unfunded) randomised controlled trial. The SMP will contain elements of information, giving training and education and telephone helpline support involving patients, relatives, carers, voluntary sector workers and podiatry services. We are currently validating a foot health disability measure as the primary outcome measure alongside measures of foot morbidity, patient satisfaction, quality of life and foot health knowledge. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Basic foot care |
Intervention | Patient self-management programme versus standard care. |
Intervention type | Other |
Primary outcome measure | EuroQol, foot disability index - to be validated, foot morbidity Index, foot health knowledge questionnaire - based on SMP, patient satisfaction questionnaire. |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 02/01/1999 |
Completion date | 04/01/2001 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 153 |
Key inclusion criteria | Feasibility study - sample of 50 subjects, mostly new referrals to the NHS podiatry service in Calderdale. |
Key exclusion criteria | Diabetes mellitis, circulatory disorders. |
Date of first enrolment | 02/01/1999 |
Date of final enrolment | 04/01/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Leeds
Leeds
LS2 9NZ
United Kingdom
LS2 9NZ
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Northern and Yorkshire (UK)
No information available
Results and Publications
Intention to publish date | |
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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? |
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Results article | 01/11/2003 | Yes | No |