Musculoskeletal DiseaseBRIDGENCT03102814
The BRIDGE Rehabilitation Trial
A study testing Current rehabilitation and The BRIDGE program in people with Musculoskeletal Disease, run by National Resource Center for Rehabilitation in Rheumatology at 8 sites in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Musculoskeletal Disease
- What is being tested?
- Current rehabilitation and The BRIDGE program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 381 participants
- Where
- 8 sitesNorway
- Study dates
- 15 Aug 2017to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cognitive impairment or severe psychiatric disorder
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Norway8 sites
Sørlandet Hospital
Arendal, 4838
Haugesund Rheumatism Hospital
Haugesund, 5528
Rehabilitering Vest
Haugesund, 5528
Lillehammer Rheumatism Hospital
Lillehammer, 2609
Meråker rehabilitation centre
Meråker, 7530
Muritunet Rehabilitation Centre
Valldal, 6210
Valnesfjord Rehabilitation Centre
Valnesfjord, Valnesfjord, 8215
Vikersund Rehabilitation Centre
Vikersund, 3370
About this study
Official title: The BRIDGE Trial: A Multicenter RCT to Improve Continuity and Quality in Rehabilitation of People With Rheumatic and Musculoskeletal Diseases
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.
Read the 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.
- Conditions
- Musculoskeletal Disease
- Being tested
- Current rehabilitation, The BRIDGE program
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Current rehabilitationBehavioural
The control group will receive the rehabilitation currently offered at each of the participating centers.
The BRIDGE programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Current rehabilitation |
| BRIDGE rehabilitation program | Experimental | In intervention phase, the BRIDGE program will be added to the current program. Receives: Behavioral: The BRIDGE program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goal attainment measured by the Patient Specific Functional Scale
Goal attainment will be measured by the Patient Specific Functional Scale
Measured: One year
Secondary outcomes (2)
Health-related quality of life measured by the EQ5D
Health-related quality of life will be measured by the EQ5D
Measured: One year
Physical function measured by the 30 sec sit to stand test
Physical function will be measured by the 30 sec sit to stand test
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start15 Aug 2017
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Resource Center for Rehabilitation in Rheumatology
- Sponsor type
- University, hospital or other
- Collaborators
- Sorlandet Hospital HF, Vikersund Rehabilitation Centre, Muritunet Rehabilitation Centre, Valnesfjord Rehabilitation Centre, Meråker Rehabilitation Centre, Rehab Vest Rehabilitation Centre, Lillehammer Rheumatism Hospital, Haugesund Rheumatism Hospital
- Responsible party
- Principal investigator, Ingvild Kjeken, National Resource Center for Rehabilitation in Rheumatology
- Investigators
- Tore K Kvien, PhD, Study director, Diakonhjemmet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102814
- Sponsor's protocol ID
- Project nr 97033
- Acronym
- BRIDGE
- Status last verified
- Feb 2020
- First submitted
- 31 Mar 2017
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berdal G, Sand-Svartrud AL, Linge AD, Aasvold AM, Tennebo K, Eppeland SG, Hagland AS, Ohldieck-Fredheim G, Lindtvedt Valaas H, Bo I, Klokkeide A, Sexton J, Azimi M, Dager TN, Kjeken I. Does follow-up really matter? A convergent mixed methods study exploring follow-up across levels of care in rehabilitation of patients with rheumatic and musculoskeletal diseases. Disabil Rehabil. 2024 Nov;46(23):5531-5544. doi: 10.1080/09638288.2024.2310170. Epub 2024 Feb 9.
PubMed 38334113Sand-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.
PubMed 35428256Sand-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.
PubMed 33610174
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BRIDGE Trial: A Multicenter RCT to Improve Continuity and Quality in Rehabilitation of People With Rheumatic and Musculoskeletal Diseases
- ClinicalTrials.gov ID
- NCT03102814
- Acronym / sponsor ID
- BRIDGE / Project nr 97033
- Conditions
- Musculoskeletal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- National Resource Center for Rehabilitation in RheumatologyUniversity, hospital or other
- Collaborators
- Sorlandet Hospital HF, Vikersund Rehabilitation Centre, Muritunet Rehabilitation Centre, Valnesfjord Rehabilitation Centre, Meråker Rehabilitation Centre, Rehab Vest Rehabilitation Centre, Lillehammer Rheumatism Hospital, Haugesund Rheumatism Hospital
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 6 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Current rehabilitation program | Active comparator | Behavioral: Current rehabilitationThe control group will receive the rehabilitation program currently provided at each participating centre at the start of the study. |
| BRIDGE rehabilitation program | Experimental | Behavioral: The BRIDGE programIn intervention phase, the BRIDGE program will be added to the current program. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Cognitive impairment or severe psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Current rehabilitationThe control group will receive the rehabilitation currently offered at each of the participating centers. | Behavioural | Current rehabilitation program |
| The BRIDGE programThe 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. | Behavioural | BRIDGE rehabilitation program |
Primary outcome
Goal attainment measured by the Patient Specific Functional Scale
Time frame: One year
Goal attainment will be measured by the Patient Specific Functional Scale
2 secondary outcomes
Health-related quality of life measured by the EQ5D
Time frame: One year
Physical function measured by the 30 sec sit to stand test
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Derived from this study: PubMed 38334113Berdal G, Sand-Svartrud AL, Linge AD, Aasvold AM, Tennebo K, Eppeland SG, Hagland AS, Ohldieck-Fredheim G, Lindtvedt Valaas H, Bo I, Klokkeide A, Sexton J, Azimi M, Dager TN, Kjeken I. Does follow-up really matter? A convergent mixed methods study exploring follow-up across levels of care in rehabilitation of patients with rheumatic and musculoskeletal diseases. Disabil Rehabil. 2024 Nov;46(23):5531-5544. doi: 10.1080/09638288.2024.2310170. Epub 2024 Feb 9.
- Derived from this study: PubMed 35428256Sand-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.
- Derived from this study: PubMed 33610174Sand-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tore K Kvien, PhD study director
Diakonhjemmet Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Current rehabilitation and The BRIDGE program in people with Musculoskeletal Disease, run by National Resource Center for Rehabilitation in Rheumatology at 8 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goal attainment measured by the Patient Specific Functional Scale (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03102814, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2020.