Activity Increase Despite Arthritis (AÏDA): design of a Phase II randomised controlled trial evaluating an active management booklet for hip and knee osteoarthritis [ISRCTN24554946]
1 Department of Primary Care and Public Health, Cardiff University, School of Medicine, North Wales Clinical School, Gwenfro Units 6-7, Wrexham Technology Park, LL13 7YP, UK
2 Centre for Health and Social Care Research, University of Huddersfield, UK
3 Arthritis Research Campaign National Primary Care Centre, Keele University, UK
4 South East Wales Trials Unit, School of Medicine, Cardiff University, UK
5 School of Sports Health and Exercise Science, Bangor University, UK
6 School of Nursing, Cardiff University, Cardiff, UK
7 Centre for Economics and Policy in Health, Bangor University, UK
8 North West Wales NHS Trust, Bangor, UK
BMC Family Practice 2009, 10:62 doi:10.1186/1471-2296-10-62Published: 4 September 2009
Hip and knee osteoarthritis is a common cause of pain and disability, which can be improved by exercise interventions. However, regular exercise is uncommon in this group because the low physical activity level in the general population is probably reduced even further by pain related fear of movement. The best method of encouraging increased activity in this patient group is not known. A booklet has been developed for patients with hip or knee osteoarthritis. It focuses on changing disadvantageous beliefs and encouraging increased physical activity.
This paper describes the design of a Phase II randomised controlled trial (RCT) to test the effectiveness of this new booklet for patients with hip and knee osteoarthritis in influencing illness and treatment beliefs, and to assess the feasibility of conducting a larger definitive RCT in terms of health status and exercise behaviour. A computerised search of four general medical practice patients' record databases will identify patients older than 50 years of age who have consulted with hip or knee pain in the previous twelve months. A random sample of 120 will be invited to participate in the RCT comparing the new booklet with a control booklet, and we expect 100 to return final questionnaires. This trial will assess the feasibility of recruitment and randomisation, the suitability of the control intervention and outcome measurement tools, and will provide an estimate of effect size. Outcomes will include beliefs about hip and knee pain, beliefs about exercise, fear avoidance, level of physical activity, health status and health service costs. They will be measured at baseline, one month and three months.
We discuss the merits of testing effectiveness in a phase II trial, in terms of intermediate outcome measures, whilst testing the processes for a larger definitive trial. We also discuss the advantages and disadvantages of testing the psychometric properties of the primary outcome measures concurrently with the trial.
Current Controlled Trials ISRCTN24554946