Evaluation of a model of integrated care for the identification and clinical management of high risk diabetic foot
| ISRCTN | ISRCTN18548500 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18548500 |
| Secondary identifying numbers | D/05/11.96/Tooke |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 29/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof John Tooke
Scientific
Scientific
Royal Devon and Exeter Healthcare NHS Trust
Barrack Road
Exeter
EX2 5AW
United Kingdom
| Phone | +44 (0)1392 403064 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Scientific title | |
| Study objectives | Diabetic foot ulceration and lower limb amputation remain major health problems and the government is committed to the reduction of amputation rates by 50%. Centralised, hospital based specialist foot services have demonstrated that it is possible to reduce amputation rate through patient education and expert medical and chiropodial care. However increasingly routine diabetic care is devolved to general practice and if foot health in the majority of people with diabetes is to be improved care arrangements need to reflect this shift. We propose to evaluate a new model of diabetic foot care, centred on the general practice based diabetic annual review. Five practices will be randomised to receive the new model of care, and associated educational input, with five matched practices continuing with current care arrangements. The success or otherwise of the initiative will be-determined by assessing 1. Patients' understanding of footcare and their attitudes to the footcare service; 2. The knowledge base of the healthcare professionals involved in diabetic footcare, and 3. The appropriateness of patients referred to subserving chiropody units and the specialist foot clinic. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Diabetes |
| Intervention | A practice visit by the specialist diabetic footcare team to deliver an educational programme; provision of, and instruction in the use of, an objective means of neuropathy assessment (Semmes-Weinstein monofilament); provision of referral guidelines and patient educational material. Control: current standard care. |
| Intervention type | Other |
| Primary outcome measure | 1. Patients' attitudes regarding the value and importance of footcare 2. Patients' footcare knowledge 3. Healthcare professionals' footcare knowledge 4. Pattern of service utilisation |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/05/1997 |
| Completion date | 31/12/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1,939 (cluster randomised practices from 10 towns) |
| Key inclusion criteria | One thousand nine hundred and thirty nine people with diabetes aged over 18 years. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/05/1997 |
| Date of final enrolment | 31/12/1998 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Devon and Exeter Healthcare NHS Trust
Exeter
EX2 5AW
United Kingdom
EX2 5AW
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 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive South West (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 | 01/08/2000 | Yes | No |
