Musculoskeletal Disease
Conditions
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.
Interventions
BEHAVIORALCurrent rehabilitation
The control group will receive the rehabilitation currently offered at each of the participating centers.
BEHAVIORALThe 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.
Sponsors
Sørlandet Hospital
Vikersund Rehabilitation Centre
Muritunet Rehabilitation Centre
Valnesfjord Rehabilitation Centre
Meråker Rehabilitation Centre
Rehab Vest Rehabilitation Centre
Lillehammer Rheumatism Hospital
Haugesund Rheumatism Hospital
National Resource Center for Rehabilitation in Rheumatology
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Goal attainment measured by the Patient Specific Functional Scale | One year | Goal attainment will be measured by the Patient Specific Functional Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life measured by the EQ5D | One year | Health-related quality of life will be measured by the EQ5D |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Function in daily activities measured by the Hannover Functional Ability Questionnaire | One year | Daily activities will be measured by the Hannover Functional Ability Questionnaire |
| Coping measured by the Effective Musculoskeletal Consumer Scale | One year | Coping will be measured by the Effective Musculoskeletal Consumer Scale |
| Pain measured on a numeric rating scale | One year | Pain will be measured on a numeric rating scale |
| Participation measured by participation scale in COOP/WONCA | One year | Participation will be measured by participation scale in COOP/WONCA |
| Mental health measured by the Hopkins Symptom Checklist | One year | Mental health will be measured by the Hopkins Symptom Checklist |
| Fatigue measured on a numeric rating scale | One Year | Fatigue will be measured on a numeric rating scale |
| Motivation for goal attainment measured on a numeric rating scale | Baseline | Motivation for goal attainment will be measured on a numeric rating scale |
Countries
Norway
Outcome results
None listed