The BRIDGE Rehabilitation Trial

Study Overview
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Brief Summary
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The main aim of this multi-centre stepped wedge randomized controlled trial is to improve the quality, professional practice and cost-effective utilization of health care resources by evaluating if a new rehabilitation program aimed at bridging gaps in rehabilitation across levels of care may increase and/or prolong the effect of rehabilitation.

Detailed Description
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The goal of rehabilitation is to help people to reach and maintain their optimal functioning and coping capabilities, and to promote independence and participation in society. According to current political documents, there are large variation in the content and quality of rehabilitation in Norway, and systems to improve coordination and communication are needed. This trial is a collaborative project between eight centres across Norway, investigating whether a new program aimed at bridging gaps in rehabilitation across levels of care increase and/or prolong the effect of rehabilitation for people with rheumatic and musculoskeletal diseases. Additionally, we will use a newly developed set of quality indicators to monitor and compare the quality of rehabilitation across different centres, and explore relationships between adherence to structure and process indicators and the outcomes of rehabilitation. The effects will be evaluated in a multi-centre stepped wedge randomized controlled trial, where participating centres switch from control (current rehabilitation program) to intervention phase (adding the BRIDGE program to the current program) in a randomized order. Primary outcome is goal attainment after seven months, and secondary outcomes are health related quality of life and function. The results will give insight in the content and organisation of current rehabilitation programs, what follow-up people want and receive in primary care, their planned and completed efforts to implement and maintain life style changes, and predictors for improvement following rehabilitation in specialist health care. Results will also have consequences on how rehabilitation is to be organized in the future regarding follow-up and coordination across levels of care. The study has been developed in close collaboration with patient research partners, clinicians and international experts, who will also contribute in the process of integrating study results in clinical practice.

Official Title
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The BRIDGE Trial: A Multicenter RCT to Improve Continuity and Quality in Rehabilitation of People With Rheumatic and Musculoskeletal Diseases

Conditions
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Musculoskeletal Disease

Intervention / Treatment
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* Behavioral: Current rehabilitation
* Behavioral: The BRIDGE program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: inflammatory rheumatic disease or osteoarthritis or fibromyalgia or low back pain or wide spread pain or osteoporosis. Having a good understanding of Norwegian and having a bank-ID Exclusion Criteria: Cognitive impairment or severe psychiatric disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: In order to evaluate the effects of the BRIDGE program, a stepped wedge cluster randomized controlled trial will be conducted. In the trial, participating centres switch from control (current rehabilitation program) to intervention phase (adding the BRIDGE program to the current program) in a randomized order. All centres start the trial simultaneously and act as controls until the point in time they are randomized to crossover from control to intervention, and all centres deliver the intervention by the end of inclusion. The stepped wedge design is suitable for a phased evaluation approach, where it is difficult to deliver two parallel interventions.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Current rehabilitation program<br>The control group will receive the rehabilitation program currently provided at each participating centre at the start of the study. | Behavioral: Current rehabilitation<br>* The control group will receive the rehabilitation currently offered at each of the participating centers.<br>|
| Experimental: BRIDGE rehabilitation program<br>In intervention phase, the BRIDGE program will be added to the current program. | Behavioral: The BRIDGE program<br>* The experimental group will additionally receive the BRIDGE program, which comprises motivational interviewing, structured goal-setting, tailored follow-up, plans for self-management, and individualised written feedback that participants can use to monitor their progress and share with important care givers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Goal attainment measured by the Patient Specific Functional Scale | Goal attainment will be measured by the Patient Specific Functional Scale | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life measured by the EQ5D | Health-related quality of life will be measured by the EQ5D | One year | 
| Physical function measured by the 30 sec sit to stand test | Physical function will be measured by the 30 sec sit to stand test | One year |