The BRIDGE Rehabilitation Trial (BRIDGE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03102814|
Recruitment Status : Active, not recruiting
First Posted : April 6, 2017
Last Update Posted : February 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Musculoskeletal Disease||Behavioral: Current rehabilitation Behavioral: The BRIDGE program||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||381 participants|
|Intervention Model:||Sequential Assignment|
|Intervention 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 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.|
|Official Title:||The BRIDGE Trial: A Multicenter RCT to Improve Continuity and Quality in Rehabilitation of People With Rheumatic and Musculoskeletal Diseases|
|Actual Study Start Date :||August 15, 2017|
|Estimated Primary Completion Date :||August 30, 2019|
|Estimated Study Completion Date :||August 30, 2019|
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.
- Goal attainment measured by the Patient Specific Functional Scale [ Time Frame: One year ]Goal attainment will be measured by the Patient Specific Functional Scale
- Health-related quality of life measured by the EQ5D [ Time Frame: One year ]Health-related quality of life will be measured by the EQ5D
- Physical function measured by the 30 sec sit to stand test [ Time Frame: One year ]Physical function will be measured by the 30 sec sit to stand test
- Pain measured on a numeric rating scale [ Time Frame: One year ]Pain will be measured on a numeric rating scale
- Fatigue measured on a numeric rating scale [ Time Frame: One Year ]Fatigue will be measured on a numeric rating scale
- Motivation for goal attainment measured on a numeric rating scale [ Time Frame: Baseline ]Motivation for goal attainment will be measured on a numeric rating scale
- Function in daily activities measured by the Hannover Functional Ability Questionnaire [ Time Frame: One year ]Daily activities will be measured by the Hannover Functional Ability Questionnaire
- Coping measured by the Effective Musculoskeletal Consumer Scale [ Time Frame: One year ]Coping will be measured by the Effective Musculoskeletal Consumer Scale
- Mental health measured by the Hopkins Symptom Checklist [ Time Frame: One year ]Mental health will be measured by the Hopkins Symptom Checklist
- Participation measured by participation scale in COOP/WONCA [ Time Frame: One year ]Participation will be measured by participation scale in COOP/WONCA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102814
|Arendal, Norway, 4838|
|Haugesund Rheumatism Hospital|
|Haugesund, Norway, 5528|
|Haugesund, Norway, 5528|
|Lillehammer Rheumatism Hospital|
|Lillehammer, Norway, 2609|
|Meråker rehabilitation centre|
|Meråker, Norway, 7530|
|Muritunet Rehabilitation Centre|
|Valldal, Norway, 6210|
|Valnesfjord Rehabilitation Centre|
|Valnesfjord, Norway, 8215|
|Vikersund Rehabilitation Centre|
|Vikersund, Norway, 3370|
|Study Director:||Tore K Kvien, PhD||Diakonhjemmet Hospital|