The BRIDGE Rehabilitation Trial

Not Applicable

Completed

• Conditions: Musculoskeletal Disease
• Interventions: Behavioral: Current rehabilitation; Behavioral: The BRIDGE program

• Registration Number: NCT03102814
• Lead Sponsor: National Resource Center for Rehabilitation in Rheumatology

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-03-31
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-06
• Study Start: 2017-08-15
• Primary Completion: 2019-08-30
• Study Completion: 2019-08-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-28
• Last Update Posted: 2020-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 381

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Current rehabilitation program	Current rehabilitation	The control group will receive the rehabilitation program currently provided at each participating centre at the start of the study.
BRIDGE rehabilitation program	The BRIDGE program	In intervention phase, the BRIDGE program will be added to the current program.

Primary Outcome Measures

Name	Time	Method
Goal attainment measured by the Patient Specific Functional Scale	One year	Goal attainment will be measured by the Patient Specific Functional Scale

Secondary Outcome Measures

Name	Time	Method
Physical function measured by the 30 sec sit to stand test	One year	Physical function will be measured by the 30 sec sit to stand test
Health-related quality of life measured by the EQ5D	One year	Health-related quality of life will be measured by the EQ5D

Trial Locations

Locations (8)

Sørlandet Hospital; 🇳🇴 Arendal, Norway

Rehabilitering Vest; 🇳🇴 Haugesund, Norway

Lillehammer Rheumatism Hospital; 🇳🇴 Lillehammer, Norway

Vikersund Rehabilitation Centre; 🇳🇴 Vikersund, Norway

Meråker rehabilitation centre; 🇳🇴 Meråker, Norway

Muritunet Rehabilitation Centre; 🇳🇴 Valldal, Norway

Valnesfjord Rehabilitation Centre; 🇳🇴 Valnesfjord, Norway

Haugesund Rheumatism Hospital; 🇳🇴 Haugesund, Norway