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 design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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	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 study start date	02/01/1999
Completion date	04/01/2001

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	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

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 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		01/11/2003		Yes	No