The BRIDGE Rehabilitation Trial (BRIDGE)

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

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.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Disease
• Intervention / Treatment: Behavioral: Current rehabilitation; Behavioral: The BRIDGE program

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 Type: Interventional
• Enrollment (Actual): 381
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Arendal, Norway, 4838
    • Sørlandet Hospital
  • Haugesund, Norway, 5528
    • Haugesund Rheumatism Hospital
  • Haugesund, Norway, 5528
    • Rehabilitering Vest
  • Lillehammer, Norway, 2609
    • Lillehammer Rheumatism Hospital
  • Meråker, Norway, 7530
    • Meråker rehabilitation centre
  • Valldal, Norway, 6210
    • Muritunet rehabilitation centre
  • Valnesfjord, Norway, 8215
    • Valnesfjord Rehabilitation Centre
  • Vikersund, Norway, 3370
    • Vikersund rehabilitation centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Current rehabilitation program; The control group will receive the rehabilitation program currently provided at each participating centre at the start of the study.	Behavioral: Current rehabilitation; The control group will receive the rehabilitation currently offered at each of the participating centers.
Experimental: BRIDGE rehabilitation program; In intervention phase, the BRIDGE program will be added to the current program.	Behavioral: The BRIDGE program; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain measured on a numeric rating scale	Pain will be measured on a numeric rating scale	One year
Fatigue measured on a numeric rating scale	Fatigue will be measured on a numeric rating scale	One Year
Motivation for goal attainment measured on a numeric rating scale	Motivation for goal attainment will be measured on a numeric rating scale	Baseline
Function in daily activities measured by the Hannover Functional Ability Questionnaire	Daily activities will be measured by the Hannover Functional Ability Questionnaire	One year
Coping measured by the Effective Musculoskeletal Consumer Scale	Coping will be measured by the Effective Musculoskeletal Consumer Scale	One year
Mental health measured by the Hopkins Symptom Checklist	Mental health will be measured by the Hopkins Symptom Checklist	One year
Participation measured by participation scale in COOP/WONCA	Participation will be measured by participation scale in COOP/WONCA	One year

Collaborators and Investigators

• Sponsor: National Resource Center for Rehabilitation in Rheumatology
• Collaborators: Haugesund Rheumatism Hospital; Sørlandet Hospital; Vikersund Rehabilitation Centre; Muritunet Rehabilitation Centre; Valnesfjord Rehabilitation Centre; Meråker Rehabilitation Centre; Rehab Vest Rehabilitation Centre; Lillehammer Rheumatism Hospital
• Investigators: Study Director: Tore K Kvien, PhD, Diakonhjemmet Hospital

Publications and helpful links

General Publications

• Sand-Svartrud AL, Berdal G, Azimi M, Bo I, Dager TN, Eppeland SG, Fredheim GO, Hagland AS, Klokkeide A, Linge AD, Sexton J, Tennebo K, Valaas HL, Mjosund K, Dagfinrud H, Kjeken I. Associations between quality of health care and clinical outcomes in patients with rheumatic and musculoskeletal diseases: a rehabilitation cohort study. BMC Musculoskelet Disord. 2022 Apr 15;23(1):357. doi: 10.1186/s12891-022-05271-3.
• Sand-Svartrud AL, Berdal G, Azimi M, Bo I, Dager TN, Eppeland SG, Fredheim GO, Hagland AS, Klokkeide A, Linge AD, Tennebo K, Valaas HL, Aasvold AM, Dagfinrud H, Kjeken I. A quality indicator set for rehabilitation services for people with rheumatic and musculoskeletal diseases demonstrates adequate responsiveness in a pre-post evaluation. BMC Health Serv Res. 2021 Feb 20;21(1):164. doi: 10.1186/s12913-021-06164-2.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2017
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 6, 2017

Study Record Updates

• Last Update Posted (Actual): March 2, 2020
• Last Update Submitted That Met QC Criteria: February 28, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: Project nr 97033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No