Condition category
Musculoskeletal Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
07/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Philip Helliwell

ORCID ID

Contact details

University of Leeds
Rheumatology & Rehabilitation Research Unit
36 Clarendon Road
Leeds
LS2 9NZ
United Kingdom
+44 (0)113 233 4952
p.helliwell@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

rctc94 441772

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Basic foot care

Intervention

Patient self-management programme versus standard care.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

02/01/1999

Overall trial end date

04/01/2001

Reason abandoned

Eligibility

Participant inclusion criteria

Feasibility study - sample of 50 subjects, mostly new referrals to the NHS podiatry service in Calderdale.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

153

Participant exclusion criteria

Diabetes mellitis, circulatory disorders.

Recruitment start date

02/01/1999

Recruitment end date

04/01/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Leeds
Leeds
LS2 9NZ
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Northern and Yorkshire (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

http://www.refer.nhs.uk/ViewRecord.asp?ID=1156

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14615000

Publication citations

  1. Waxman R, Woodburn H, Powell M, Woodburn J, Blackburn S, Helliwell P, FOOTSTEP: a randomized controlled trial investigating the clinical and cost effectiveness of a patient self-management program for basic foot care in the elderly., J Clin Epidemiol, 2003, 56, 11, 1092-1099.

Additional files

Editorial Notes