The BRIDGE Rehabilitation Trial (BRIDGE)
Primary Purpose
Musculoskeletal Disease
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Current rehabilitation
The BRIDGE program
Sponsored by
About this trial
This is an interventional treatment trial for Musculoskeletal Disease
Eligibility Criteria
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
Sites / Locations
- Sørlandet Hospital
- Haugesund Rheumatism Hospital
- Rehabilitering Vest
- Lillehammer Rheumatism Hospital
- Meråker rehabilitation centre
- Muritunet Rehabilitation Centre
- Valnesfjord Rehabilitation Centre
- Vikersund Rehabilitation Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Current rehabilitation program
BRIDGE rehabilitation program
Arm Description
The control group will receive the rehabilitation program currently provided at each participating centre at the start of the study.
In intervention phase, the BRIDGE program will be added to the current program.
Outcomes
Primary Outcome Measures
Goal attainment measured by the Patient Specific Functional Scale
Goal attainment will be measured by the Patient Specific Functional Scale
Secondary Outcome Measures
Health-related quality of life measured by the EQ5D
Health-related quality of life will be measured by the EQ5D
Physical function measured by the 30 sec sit to stand test
Physical function will be measured by the 30 sec sit to stand test
Full Information
NCT ID
NCT03102814
First Posted
March 31, 2017
Last Updated
February 28, 2020
Sponsor
National Resource Center for Rehabilitation in Rheumatology
Collaborators
Sørlandet Hospital, Vikersund Rehabilitation Centre, Muritunet Rehabilitation Centre, Valnesfjord Rehabilitation Centre, Meråker Rehabilitation Centre, Rehab Vest Rehabilitation Centre, Lillehammer Rheumatism Hospital, Haugesund Rheumatism Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03102814
Brief Title
The BRIDGE Rehabilitation Trial
Acronym
BRIDGE
Official Title
The BRIDGE Trial: A Multicenter RCT to Improve Continuity and Quality in Rehabilitation of People With Rheumatic and Musculoskeletal Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Resource Center for Rehabilitation in Rheumatology
Collaborators
Sørlandet Hospital, Vikersund Rehabilitation Centre, Muritunet Rehabilitation Centre, Valnesfjord Rehabilitation Centre, Meråker Rehabilitation Centre, Rehab Vest Rehabilitation Centre, Lillehammer Rheumatism Hospital, Haugesund Rheumatism Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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
Investigator
Masking Description
Due to the nature of the study intervention, it is not possible to blind participants or the health care providers. However, the statistician who will perform the main statistical analyses will be blinded to group allocation.
Allocation
Randomized
Enrollment
381 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Current rehabilitation program
Arm Type
Active Comparator
Arm Description
The control group will receive the rehabilitation program currently provided at each participating centre at the start of the study.
Arm Title
BRIDGE rehabilitation program
Arm Type
Experimental
Arm Description
In intervention phase, the BRIDGE program will be added to the current program.
Intervention Type
Behavioral
Intervention Name(s)
Current rehabilitation
Intervention Description
The control group will receive the rehabilitation currently offered at each of the participating centers.
Intervention Type
Behavioral
Intervention Name(s)
The BRIDGE program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Goal attainment measured by the Patient Specific Functional Scale
Description
Goal attainment will be measured by the Patient Specific Functional Scale
Time Frame
One year
Secondary Outcome Measure Information:
Title
Health-related quality of life measured by the EQ5D
Description
Health-related quality of life will be measured by the EQ5D
Time Frame
One year
Title
Physical function measured by the 30 sec sit to stand test
Description
Physical function will be measured by the 30 sec sit to stand test
Time Frame
One year
Other Pre-specified Outcome Measures:
Title
Pain measured on a numeric rating scale
Description
Pain will be measured on a numeric rating scale
Time Frame
One year
Title
Fatigue measured on a numeric rating scale
Description
Fatigue will be measured on a numeric rating scale
Time Frame
One Year
Title
Motivation for goal attainment measured on a numeric rating scale
Description
Motivation for goal attainment will be measured on a numeric rating scale
Time Frame
Baseline
Title
Function in daily activities measured by the Hannover Functional Ability Questionnaire
Description
Daily activities will be measured by the Hannover Functional Ability Questionnaire
Time Frame
One year
Title
Coping measured by the Effective Musculoskeletal Consumer Scale
Description
Coping will be measured by the Effective Musculoskeletal Consumer Scale
Time Frame
One year
Title
Mental health measured by the Hopkins Symptom Checklist
Description
Mental health will be measured by the Hopkins Symptom Checklist
Time Frame
One year
Title
Participation measured by participation scale in COOP/WONCA
Description
Participation will be measured by participation scale in COOP/WONCA
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tore K Kvien, PhD
Organizational Affiliation
Diakonhjemmet Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Sørlandet Hospital
City
Arendal
ZIP/Postal Code
4838
Country
Norway
Facility Name
Haugesund Rheumatism Hospital
City
Haugesund
ZIP/Postal Code
5528
Country
Norway
Facility Name
Rehabilitering Vest
City
Haugesund
ZIP/Postal Code
5528
Country
Norway
Facility Name
Lillehammer Rheumatism Hospital
City
Lillehammer
ZIP/Postal Code
2609
Country
Norway
Facility Name
Meråker rehabilitation centre
City
Meråker
ZIP/Postal Code
7530
Country
Norway
Facility Name
Muritunet Rehabilitation Centre
City
Valldal
ZIP/Postal Code
6210
Country
Norway
Facility Name
Valnesfjord Rehabilitation Centre
City
Valnesfjord
ZIP/Postal Code
8215
Country
Norway
Facility Name
Vikersund Rehabilitation Centre
City
Vikersund
ZIP/Postal Code
3370
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35428256
Citation
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.
Results Reference
derived
PubMed Identifier
33610174
Citation
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.
Results Reference
derived
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The BRIDGE Rehabilitation Trial
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