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
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
-
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.