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Open Access Study protocol

Protocol for the Foot in Juvenile Idiopathic Arthritis trial (FiJIA): a randomised controlled trial of an integrated foot care programme for foot problems in JIA

Gordon J Hendry1*, Deborah E Turner1, John McColl2, Paula K Lorgelly3, Roger D Sturrock4, Gordon F Watt1, Michael Browne5, Janet Gardner-Medwin5, Lorraine Friel6 and Jim Woodburn1

Author Affiliations

1 School of Health and Social Care, Glasgow Caledonian University, Cowcaddens Road, Glasgow, UK

2 Department of Statistics, University of Glasgow, University Avenue, Glasgow, UK

3 Division of Community Based Sciences, University of Glasgow, University Avenue, Glasgow, UK

4 Centre for Rheumatic Diseases, University of Glasgow, University Avenue, Glasgow, UK

5 Department of Child Health, University of Glasgow, University Avenue, Glasgow, UK

6 NHS Greater Glasgow and Clyde, Glasgow Royal Infirmary, 16 Alexandra Parade, Glasgow, UK

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Journal of Foot and Ankle Research 2009, 2:21  doi:10.1186/1757-1146-2-21

Published: 30 June 2009

Abstract

Background

Foot and ankle problems are a common but relatively neglected manifestation of juvenile idiopathic arthritis. Studies of medical and non-medical interventions have shown that clinical outcome measures can be improved. However existing data has been drawn from small non-randomised clinical studies of single interventions that appear to under-represent the adult population suffering from juvenile idiopathic arthritis. To date, no evidence of combined therapies or integrated care for juvenile idiopathic arthritis patients with foot and ankle problems exists.

Methods/design

An exploratory phase II non-pharmacological randomised controlled trial where patients including young children, adolescents and adults with juvenile idiopathic arthritis and associated foot/ankle problems will be randomised to receive integrated podiatric care via a new foot care programme, or to receive standard podiatry care. Sixty patients (30 in each arm) including children, adolescents and adults diagnosed with juvenile idiopathic arthritis who satisfy the inclusion and exclusion criteria will be recruited from 2 outpatient centres of paediatric and adult rheumatology respectively. Participants will be randomised by process of minimisation using the Minim software package. The primary outcome measure is the foot related impairment measured by the Juvenile Arthritis Disability Index questionnaire's impairment domain at 6 and 12 months, with secondary outcomes including disease activity score, foot deformity score, active/limited foot joint counts, spatio-temporal and plantar-pressure gait parameters, health related quality of life and semi-quantitative ultrasonography score for inflammatory foot lesions. The new foot care programme will comprise rapid assessment and investigation, targeted treatment, with detailed outcome assessment and follow-up at minimum intervals of 3 months. Data will be collected at baseline, 6 months and 12 months from baseline. Intention to treat data analysis will be conducted.

A full health economic evaluation will be conducted alongside the trial and will evaluate the cost effectiveness of the intervention. This will consider the cost per improvement in Juvenile Arthritis Disability Index, and cost per quality adjusted life year gained. In addition, a discrete choice experiment will elicit willingness to pay values and a cost benefit analysis will also be undertaken.

Trial Registration

Trial registration number: UKCRN5045