The BRIDGE Rehabilitation Trial

NCT ID: NCT03102814

Last Updated: 2020-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

381 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-15

Study Completion Date

2019-08-30

Brief Summary

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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

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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.

Conditions

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Musculoskeletal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
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.

Study Groups

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Current rehabilitation program

The control group will receive the rehabilitation program currently provided at each participating centre at the start of the study.

Group Type ACTIVE_COMPARATOR

Current rehabilitation

Intervention Type BEHAVIORAL

The control group will receive the rehabilitation currently offered at each of the participating centers.

BRIDGE rehabilitation program

In intervention phase, the BRIDGE program will be added to the current program.

Group Type EXPERIMENTAL

The BRIDGE program

Intervention Type BEHAVIORAL

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.

Interventions

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Current rehabilitation

The control group will receive the rehabilitation currently offered at each of the participating centers.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sørlandet Hospital

UNKNOWN

Sponsor Role collaborator

Vikersund Rehabilitation Centre

UNKNOWN

Sponsor Role collaborator

Muritunet Rehabilitation Centre

UNKNOWN

Sponsor Role collaborator

Valnesfjord Rehabilitation Centre

UNKNOWN

Sponsor Role collaborator

Meråker Rehabilitation Centre

UNKNOWN

Sponsor Role collaborator

Rehab Vest Rehabilitation Centre

UNKNOWN

Sponsor Role collaborator

Lillehammer Rheumatism Hospital

UNKNOWN

Sponsor Role collaborator

Haugesund Rheumatism Hospital

OTHER

Sponsor Role collaborator

National Resource Center for Rehabilitation in Rheumatology

OTHER

Sponsor Role lead

Responsible Party

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Ingvild Kjeken

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tore K Kvien, PhD

Role: STUDY_DIRECTOR

Diakonhjemmet Hospital

Locations

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Valnesfjord Rehabilitation Centre

Valnesfjord, Valnesfjord, Norway

Site Status

Sørlandet Hospital

Arendal, , Norway

Site Status

Haugesund Rheumatism Hospital

Haugesund, , Norway

Site Status

Rehabilitering Vest

Haugesund, , Norway

Site Status

Lillehammer Rheumatism Hospital

Lillehammer, , Norway

Site Status

Meråker rehabilitation centre

Meråker, , Norway

Site Status

Muritunet Rehabilitation Centre

Valldal, , Norway

Site Status

Vikersund Rehabilitation Centre

Vikersund, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 35428256 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33610174 (View on PubMed)

Other Identifiers

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Project nr 97033

Identifier Type: -

Identifier Source: org_study_id

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