Clinical trial NCT03102814: The BRIDGE Rehabilitation Trial
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
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Disease
Lead sponsor: National Resource Center for Rehabilitation in Rheumatology
Sponsor class: OTHER
Collaborators: name: Sørlandet Hospital
name: Vikersund Rehabilitation Centre
name: Muritunet Rehabilitation Centre
name: Valnesfjord Rehabilitation Centre
name: Meråker Rehabilitation Centre
name: Rehab Vest Rehabilitation Centre
name: Lillehammer Rheumatism Hospital
name: Haugesund Rheumatism Hospital
First posted: 2017-04-06
Enrollment: 381
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Goal attainment measured by the Patient Specific Functional Scale
timeFrame: One year
Secondary outcomes:
measure: Health-related quality of life measured by the EQ5D
timeFrame: One year
measure: Physical function measured by the 30 sec sit to stand test
timeFrame: One year
Other outcomes:
measure: Pain measured on a numeric rating scale
timeFrame: One year
measure: Fatigue measured on a numeric rating scale
timeFrame: One Year
measure: Motivation for goal attainment measured on a numeric rating scale
timeFrame: Baseline
measure: Function in daily activities measured by the Hannover Functional Ability Questionnaire
timeFrame: One year
measure: Coping measured by the Effective Musculoskeletal Consumer Scale
timeFrame: One year
measure: Mental health measured by the Hopkins Symptom Checklist
timeFrame: One year
measure: Participation measured by participation scale in COOP/WONCA
timeFrame: One year
Locations:
city: Arendal
country: Norway
facility: Sørlandet Hospital
city: Haugesund
country: Norway
facility: Haugesund Rheumatism Hospital
city: Haugesund
country: Norway
facility: Rehabilitering Vest
city: Lillehammer
country: Norway
facility: Lillehammer Rheumatism Hospital
city: Meråker
country: Norway
facility: Meråker rehabilitation centre
city: Valldal
country: Norway
facility: Muritunet Rehabilitation Centre
city: Valnesfjord
country: Norway
facility: Valnesfjord Rehabilitation Centre
city: Vikersund
country: Norway
facility: Vikersund Rehabilitation Centre
Study officials:
affiliation: Diakonhjemmet Hospital
name: Tore K Kvien, PhD
role: STUDY_DIRECTOR
References:
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.
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.