The BRIDGE Rehabilitation Trial

• Sponsor: National Resource Center for Rehabilitation in Rheumatology (Other)
• Overall Status: Completed
• CT.gov ID: NCT03102814
• Collaborator: Sørlandet Hospital (Other), Vikersund Rehabilitation Centre (Other), Muritunet Rehabilitation Centre (Other), Valnesfjord Rehabilitation Centre (Other), Meråker Rehabilitation Centre (Other), Rehab Vest Rehabilitation Centre (Other), Lillehammer Rheumatism Hospital (Other), Haugesund Rheumatism Hospital (Other)
• Enrollment: 381
• Locations: 8
• Arms: 2
• Actual Duration (Months): 24.5
• Patients Per Site: 47.6
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• 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.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: Aug 15, 2017
• Actual Primary Completion Date: Aug 30, 2019
• Actual Study Completion Date: Aug 30, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Goal attainment measured by the Patient Specific Functional Scale [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 [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 [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 [One year]

   Pain will be measured on a numeric rating scale

2. Fatigue measured on a numeric rating scale [One Year]

   Fatigue will be measured on a numeric rating scale

3. Motivation for goal attainment measured on a numeric rating scale [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 [One year]

   Daily activities will be measured by the Hannover Functional Ability Questionnaire

5. Coping measured by the Effective Musculoskeletal Consumer Scale [One year]

   Coping will be measured by the Effective Musculoskeletal Consumer Scale

6. Mental health measured by the Hopkins Symptom Checklist [One year]

   Mental health will be measured by the Hopkins Symptom Checklist

7. Participation measured by participation scale in COOP/WONCA [One year]

   Participation will be measured by participation scale in COOP/WONCA

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sørlandet Hospital	Arendal		Norway	4838
2	Haugesund Rheumatism Hospital	Haugesund		Norway	5528
3	Rehabilitering Vest	Haugesund		Norway	5528
4	Lillehammer Rheumatism Hospital	Lillehammer		Norway	2609
5	Meråker rehabilitation centre	Meråker		Norway	7530
6	Muritunet Rehabilitation Centre	Valldal		Norway	6210
7	Valnesfjord Rehabilitation Centre	Valnesfjord		Norway	8215
8	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

• Study Director: Tore K Kvien, PhD, Diakonhjemmet Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ingvild Kjeken, Professor, National Resource Center for Rehabilitation in Rheumatology
• ClinicalTrials.gov Identifier: NCT03102814
• Other Study ID Numbers: Project nr 97033
• First Posted: Apr 6, 2017
• Last Update Posted: Mar 2, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Musculoskeletal Diseases

Study Results

No Results Posted as of Mar 2, 2020