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The BRIDGE Rehabilitation Trial (BRIDGE)

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ClinicalTrials.gov Identifier: NCT03102814
Recruitment Status : Active, not recruiting
First Posted : April 6, 2017
Last Update Posted : February 7, 2019
Sponsor:
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
Information provided by (Responsible Party):
Ingvild Kjeken, 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.

Condition or disease Intervention/treatment Phase
Musculoskeletal Disease Behavioral: Current rehabilitation Behavioral: The BRIDGE program Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 381 participants
Allocation: Randomized
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: Single (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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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.




Primary Outcome Measures :
  1. Goal attainment measured by the Patient Specific Functional Scale [ Time Frame: One year ]
    Goal attainment will be measured by the Patient Specific Functional Scale


Secondary Outcome Measures :
  1. Health-related quality of life measured by the EQ5D [ Time Frame: One year ]
    Health-related quality of life will be measured by the EQ5D

  2. 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


Other Outcome Measures:
  1. Pain measured on a numeric rating scale [ Time Frame: One year ]
    Pain will be measured on a numeric rating scale

  2. Fatigue measured on a numeric rating scale [ Time Frame: One Year ]
    Fatigue will be measured on a numeric rating scale

  3. 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

  4. 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

  5. Coping measured by the Effective Musculoskeletal Consumer Scale [ Time Frame: One year ]
    Coping will be measured by the Effective Musculoskeletal Consumer Scale

  6. Mental health measured by the Hopkins Symptom Checklist [ Time Frame: One year ]
    Mental health will be measured by the Hopkins Symptom Checklist

  7. Participation measured by participation scale in COOP/WONCA [ Time Frame: One year ]
    Participation will be measured by participation scale in COOP/WONCA



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Norway
Sørlandet Hospital
Arendal, Norway, 4838
Haugesund Rheumatism Hospital
Haugesund, Norway, 5528
Rehabilitering Vest
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
Sponsors and Collaborators
National Resource Center for Rehabilitation in Rheumatology
Sørlandet Hospital
Vikersund Rehabilitation Centre
Muritunet Rehabilitation Centre
Valnesfjord Rehabilitation Centre
Meråker Rehabilitation Centre
Rehab Vest Rehabilitation Centre
Lillehammer Rheumatism Hospital
Haugesund Rheumatism Hospital
Investigators
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Study Director: Tore K Kvien, PhD Diakonhjemmet Hospital

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Responsible Party: Ingvild Kjeken, Professor, National Resource Center for Rehabilitation in Rheumatology
ClinicalTrials.gov Identifier: NCT03102814     History of Changes
Other Study ID Numbers: Project nr 97033
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Musculoskeletal Diseases