Abstract
BackgroundComprehensive rehabilitation, involving health professionals from various disciplines, is widely used as an adjunct to pharmacological and surgical treatment in people with rheumatic diseases. However, the evidence for the clinical- and cost-effectiveness of such interventions is limited, and the majority of those who receive rehabilitation are back to their initial health status six to 12 months after discharge.Methods/designTo evaluate the goal attainment, health effects and cost-effectiveness of a new rehabilitation programme compared to current traditional rehabilitation programmes for people with rheumatic diseases, a stepped-wedge cluster randomized trial will be performed. Patients admitted for rehabilitation at six centres in the south-eastern part of Norway will be invited to participate. In the trial, six participating centres will switch from a control (current rehabilitation programme) to an intervention phase (the new rehabilitation programme) in a randomized order. Supported by recent research, the new programme will be a supplement to the existing programme at each centre, and will comprise four elements designed to enhance and support lifestyle changes introduced in the rehabilitation period: structured goal-planning, motivational interviewing, a self-help booklet and four follow-up telephone calls during the first five months following discharge. The primary outcome will be health-related quality of life and goal attainment, as measured by the Patient Generated Index directly before and after the rehabilitation stay, as well as after six and 12 months. Secondary outcomes will include self-reported pain, fatigue, a global assessment of disease activity and motivation for change (measured on 11-point numeric ratings scales), health-related quality of life as measured by the Short Form 36 Health Survey (SF-36) and utility assessed by the SF6D utility index.The main analysis will be on an intention to treat basis and will assess the clinical- and cost-effectiveness of the structured goal planning and tailored follow-up rehabilitation programme for patients with rheumatic diseases.DiscussionThe findings will constitute an important contribution to more cost-effective- and evidence-based rehabilitation services for people with rheumatic diseases.Trial registrationISRCTN91433175.
Highlights
Comprehensive rehabilitation, involving health professionals from various disciplines, is widely used as an adjunct to pharmacological and surgical treatment in people with rheumatic diseases
The findings will constitute an important contribution to more cost-effective- and evidence-based rehabilitation services for people with rheumatic diseases
Motivational interviewing: The therapeutic interventions offered in the rehabilitation intervention, the self-help booklet and the telephone follow-up calls will all be based on principles derived from cognitive behavioural therapy and motivational interviewing (MI) [27,28]
Summary
Comprehensive rehabilitation, involving health professionals from various disciplines, is widely used as an adjunct to pharmacological and surgical treatment in people with rheumatic diseases. This paper outlines the protocol for a study where the main aim will be to assess the effects of a structured goal planning and tailored follow-up programme in rehabilitation for patients with rheumatic diseases, using a multicentre, stepped-wedge randomized controlled design. As this probably will occur in both groups, it will, not affect the effect estimate, calculated as the differences between groups In this trial, we will use the SF-36 as a standardised generic measure of health related quality of life. The combination of a patient-specific measure and a questionnaire with standardised items may ensure that different of aspects of health related quality of life are captured, and will allow for comparison of populations and results across studies. All authors have provided feedback on drafts and have read and approved the final manuscript
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