The BRIDGE Rehabilitation Trial

NCT03102814 | Completed

• 1 other identifier: Project nr 97033
• Study Type: interventional
• Target: 381
• Locations: 1 country
• Sites: 8

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.

Conditions

Musculoskeletal Disease

Outcome Measures

Primary Outcomes (1)

• Goal attainment measured by the Patient Specific Functional Scale

  Goal attainment will be measured by the Patient Specific Functional Scale

  One year

Secondary Outcomes (2)

• Health-related quality of life measured by the EQ5D

  One year

• Physical function measured by the 30 sec sit to stand test

  One year

Other Outcomes (7)

• Pain measured on a numeric rating scale

  One year

• Fatigue measured on a numeric rating scale

  One Year

• Motivation for goal attainment measured on a numeric rating scale

  Baseline

Study Arms (2)

Current rehabilitation program

ACTIVE COMPARATOR

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

Behavioral: Current rehabilitation

BRIDGE rehabilitation program

EXPERIMENTAL

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

Behavioral: The BRIDGE program

Interventions

Current rehabilitation BEHAVIORAL

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

Current rehabilitation program

The BRIDGE program 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.

BRIDGE rehabilitation program

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cognitive impairment or severe psychiatric disorder

Sponsors & Collaborators

• National Resource Center for Rehabilitation in Rheumatology: lead
• Sørlandet Hospital: collaborator
• Vikersund Rehabilitation Centre: collaborator
• Muritunet Rehabilitation Centre: collaborator
• Valnesfjord Rehabilitation Centre: collaborator
• Meråker Rehabilitation Centre: collaborator
• Rehab Vest Rehabilitation Centre: collaborator
• Lillehammer Rheumatism Hospital: collaborator
• Haugesund Rheumatism Hospital: collaborator

Study Sites (8)

Valnesfjord Rehabilitation Centre

Valnesfjord, Valnesfjord, 8215, Norway

Location

Sørlandet Hospital

Arendal, 4838, Norway

Location

Haugesund Rheumatism Hospital

Haugesund, 5528, Norway

Location

Rehabilitering Vest

Haugesund, 5528, Norway

Location

Lillehammer Rheumatism Hospital

Lillehammer, 2609, Norway

Location

Meråker rehabilitation centre

Meråker, 7530, Norway

Location

Muritunet Rehabilitation Centre

Valldal, 6210, Norway

Location

Vikersund Rehabilitation Centre

Vikersund, 3370, Norway

Location

Related Publications (2)

• 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.

  PMID: 35428256 DERIVED

• 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.

  PMID: 33610174 DERIVED

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

• Tore K Kvien, PhD

  Diakonhjemmet Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 6, 2017
• Study Start: August 15, 2017
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: March 2, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (8)