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
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

University of Leeds
Rheumatology & Rehabilitation Research Unit
36 Clarendon Road
Leeds
LS2 9NZ
United Kingdom

Phone +44 (0)113 233 4952
Email p.helliwell@leeds.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesTo 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) studiedBasic foot care
InterventionPatient self-management programme versus standard care.
Intervention typeOther
Primary outcome measureEuroQol, foot disability index - to be validated, foot morbidity Index, foot health knowledge questionnaire - based on SMP, patient satisfaction questionnaire.
Secondary outcome measuresNot provided at time of registration
Overall study start date02/01/1999
Completion date04/01/2001

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants153
Key inclusion criteriaFeasibility study - sample of 50 subjects, mostly new referrals to the NHS podiatry service in Calderdale.
Key exclusion criteriaDiabetes mellitis, circulatory disorders.
Date of first enrolment02/01/1999
Date of final enrolment04/01/2001

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Leeds
Leeds
LS2 9NZ
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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