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 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87471242 |
| Protocol serial number | rctc94 441772 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Northern and Yorkshire (UK) |
- 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 |
|---|---|
| p.helliwell@leeds.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
EuroQol, foot disability index - to be validated, foot morbidity Index, foot health knowledge questionnaire - based on SMP, patient satisfaction questionnaire. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 04/01/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
University of Leeds
Leeds
LS2 9NZ
United Kingdom
LS2 9NZ
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 | 01/11/2003 | Yes | No |
