A randomised controlled trial of occupational therapy for people with early rheumatoid arthritis.(Extended Report)

Background: Occupational therapy (OT) aims at improving performance of daily living tasks, facilitating successful adjustments in lifestyle, and preventing losses of function.

Objective: To evaluate the effects of a pragmatic, comprehensive OT programme on self management and health status of people with early rheumatoid arthritis (RA) (<2.5 years).

Methods: A randomised, controlled "assessor blinded" trial was conducted with assessments made at entry, 6, 12, and 24 months. Main outcomes were AIMS2: physical function (PF), pain visual analogue scale (VAS), and Arthritis Self-Efficacy Scale (ASES).

Results: Groups had similar disease duration (9 months OT (n = 162) v 10 months control (n = 164)). The OT group received 7.57 (SD 3.04) hours of therapy. Self management significantly increased in the OT group. Otherwise, there were no significant differences in any outcome measures, or between groups, by ACR functional class: AIMS2: PF (F=0.04; p=0.96); pain VAS (F=0.29; p=0.74); total ASES score (F=0.93; p=0.39).

Conclusions: OT improved self management but not health status in early RA. Functional ability remains reasonably good for many in the first five years, so preventive benefits of self management may not yet be apparent and longer follow up is needed. Although many considered the education and therapy useful, insufficient numbers in the OT group used self management sufficiently to make a difference. Behavioural approaches can improve adherence and, potentially, the long term benefits. Future research should evaluate OT as a complex intervention and develop programmes from a theoretical and evidence base.

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The development of early, aggressive treatment in rheumatoid arthritis (RA) has led to occupational therapy (OT), physiotherapy, and patient education interventions also being provided earlier. By providing disease information, facilitating a positive attitude towards being a self manager, and teaching effective strategies for self management, people with RA may be empowered to take a "preventive" approach to help maintain or improve health, minimise dysfunction, and promote optimum participation in normal activities. (1)

OT includes both therapeutic and educational interventions and aims at improving performance of daily living tasks, facilitating successful adjustments in lifestyle, and preventing losses of function. (2) Therapists also aim at improving psychological adjustment to living with arthritis by enabling people to have a greater sense of control of their symptoms through using self management methods and improving self efficacy. OT emphasises maintaining hand function and, as hand involvement occurs early in the disease, the occupational therapist is often the first or only therapist that patients visit. (1) Treatment includes assessment of functional (personal and domestic activities of daily living (ADL), work and leisure), physical, psychological, and social abilities and the person's understanding of their disease. Individualised treatment programmes are developed including arthritis education (individual and group), ADL training, joint protection, fatigue management and exercise (particularly for the hand and arm), splinting (wrist/hand, feet, and neck as appropriate), assistive devices, work and leisure counselling, sexual advice, relaxation, and pain and stress management training as necessary. Interventions emphasise achieving empathetic rapport and providing counselling and support appropriate to the person's needs to explore the impact of RA on their lives and assist in adjusting lifestyle.

This approach has been shown to be effective with people with established RA. Helewa et al conducted a crossover trial with 105 people with RA, aged 18-70 years, disease duration of 8-10 years, with moderate to severe RA. (3) A comprehensive OT programme was provided and significant improvements in ADL and mobility were reported. The authors considered the six week follow up probably too short to detect changes in other measures such as pain, depression, and social function. There have been no other randomised controlled trials of comprehensive OT in RA. Specific OT interventions have also been shown to be effective in people with longer disease duration. Hand exercises can increase grip and maintain range of movement in people with moderate RA 6-10 years after diagnosis. (4-7) Wrist working splints reduce pain during activity in those with moderate RA 3-8 years after diagnosis. (8-10) Joint protection, in the short term, reduces pain, tender joint counts, and improves functional ability in women with mild-moderate RA (average eight years' duration (11-13). Few OT studies have reported results specific to people with early RA. Joint protection education has been shown to be effective in reducing pain, early morning stiffness, and numbers of disease flare ups, and increasing grip strength in those with mild to moderate RA on average 18 months after diagnosis (range 0-5 years) and with hand function problems. (14) A recent systematic review has concluded that there is limited but encouraging evidence that OT has a positive effect on functional ability and pain in people with RA. (15)

Based on limited evidence from the effectiveness of OT in later stage RA, there has been a major service shift to provide OT and patient education early in order to help people adopt a preventive approach and adjust their lifestyle successfully. However, there have been no randomised controlled trials of OT in early RA to evaluate whether this secondary preventive approach is effective. This study aimed at evaluating a comprehensive OT programme on the effect of self management on functional, disease, physical, and psychosocial status of people with early RA.

PATIENTS AND METHODS

Patients

People with RA were recruited from 11 hospitals in the former North Thames Regional Health Authority. People were eligible to participate if aged over 18 years; diagnosed with RA by a consultant rheumatologist within the past 2.5 years; required active medical treatment; had had no or minimal OT previously; and could speak and read English adequately to complete assessments.

Trial design

A randomised, controlled, "assessor blinded" clinical trial was conducted. Ethical approval was obtained before the study starting at each hospital. Rheumatologists referred patients from outpatient clinics. After referral, patients were contacted with an invitation letter and information sheet. Those agreeing to participate were randomly allocated to the OT plus usual rheumatology care group or to the usual rheumatology care only control group. Normally there was no or minimal OT and physiotherapy available for people with early RA at 9/11 of the hospitals, unless they had marked functional difficulties. Most departments did not have rheumatology nurse practitioners. Computer generated random numbers were used with block allocation (16) for each centre, using pre-prepared sealed envelopes, to ensure an even distribution of OT and control groups across all centres.

Assessments were conducted at participants' referring hospitals. The independent assessor, before the baseline assessment, explained the trial further, any questions were answered, and informed written consent obtained. Participants were assessed at baseline, 6, 12, and 24 months. The study was conducted between 1996 and 2002.

Sample size

Change in functional ability was selected to calculate sample size. Boers and Tugwell recommend that a 20% difference in group scores can be considered clinically meaningful. (17) Using published Health Assessment Questionnaire (HAQ) data from a study of people with <1 year's disease duration, (18) with a mean score of 1.3 (SD 0.8) (power 80%, p = 0.05), a minimum of 150 people were needed in each group.

Intervention

After baseline assessment, participants randomly allocated to OT were referred on by the trial manager. Therapists started treatment within 10 days of referral and completed this within 6-8 weeks whenever possible. Participants knew of their group allocation at this point. OT was provided over five sessions: four one-hour individual treatments (usually held weekly) and a two-hour group arthritis education programme (AEP), with extra appointments if necessary. Participants were reviewed at 6 and 12 months (one hour appointments). The intervention lasted for eight hours over one year. The …