The BRIDGE Rehabilitation Trial

Musculoskeletal Disease Clinical Trial

— BRIDGE  

Official title:

The BRIDGE Trial: A Multicenter RCT to Improve Continuity and Quality in Rehabilitation of People With Rheumatic and Musculoskeletal Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03102814
• Other study ID #: Project nr 97033
• Status: Completed
• Phase: N/A
• Start date: August 15, 2017
• Est. completion date: August 30, 2019

Study information

• Verified date: February 2020
• Source: National Resource Center for Rehabilitation in Rheumatology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 381
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Disease
• Musculoskeletal Diseases

Intervention

Behavioral:
• Current rehabilitation
The control group will receive the rehabilitation currently offered at each of the participating centers.
• 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.

Locations

Country	Name	City	State
Norway	Sørlandet Hospital	Arendal
Norway	Haugesund Rheumatism Hospital	Haugesund
Norway	Rehabilitering Vest	Haugesund
Norway	Lillehammer Rheumatism Hospital	Lillehammer
Norway	Meråker rehabilitation centre	Meråker
Norway	Muritunet Rehabilitation Centre	Valldal
Norway	Valnesfjord Rehabilitation Centre	Valnesfjord
Norway	Vikersund Rehabilitation Centre	Vikersund

Sponsors (9)

Lead Sponsor	Collaborator
National Resource Center for Rehabilitation in Rheumatology	Haugesund Rheumatism Hospital, Lillehammer Rheumatism Hospital, Meråker Rehabilitation Centre, Muritunet Rehabilitation Centre, Rehab Vest Rehabilitation Centre, Sørlandet Hospital, Valnesfjord Rehabilitation Centre, Vikersund Rehabilitation Centre

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain measured on a numeric rating scale	Pain will be measured on a numeric rating scale	One year
Other	Fatigue measured on a numeric rating scale	Fatigue will be measured on a numeric rating scale	One Year
Other	Motivation for goal attainment measured on a numeric rating scale	Motivation for goal attainment will be measured on a numeric rating scale	Baseline
Other	Function in daily activities measured by the Hannover Functional Ability Questionnaire	Daily activities will be measured by the Hannover Functional Ability Questionnaire	One year
Other	Coping measured by the Effective Musculoskeletal Consumer Scale	Coping will be measured by the Effective Musculoskeletal Consumer Scale	One year
Other	Mental health measured by the Hopkins Symptom Checklist	Mental health will be measured by the Hopkins Symptom Checklist	One year
Other	Participation measured by participation scale in COOP/WONCA	Participation will be measured by participation scale in COOP/WONCA	One year
Primary	Goal attainment measured by the Patient Specific Functional Scale	Goal attainment will be measured by the Patient Specific Functional Scale	One year
Secondary	Health-related quality of life measured by the EQ5D	Health-related quality of life will be measured by the EQ5D	One year
Secondary	Physical function measured by the 30 sec sit to stand test	Physical function will be measured by the 30 sec sit to stand test	One year