- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03733847
Rehabilitation Trajectories
Rehabilitation Trajectories. A Study of Rehabilitation Processes Across Health Care Levels in Patients With Rheumatic and Musculoskeletal Diseases
Study Overview
Status
Conditions
Detailed Description
There is an urgent need to develop rehabilitation trajectories that ensure coordination and communication between health care levels, support of self-management and self-monitoring, and follow-up tailored to patients' needs. Such trajectories should be based on evidence from current practice. The "Rehabilitation trajectories" project will systematically explore and describe current practice of planned and implemented follow-up and self-management strategies in primary health care during the first year after rehabilitation for patients with musculoskeletal diseases. Further, a newly developed core set of PROMs designed for evaluation of rehabilitation in RMDs and a self-monitoring web-based system will be tested for feasibility. Knowledge of patients' experiences and use of this self-monitoring system as a self-management and communication tool is needed in order to improve and integrate such e-technology in future care.
The Rehabilitation Trajectory study is a multi-centre study, led by the National Unit on Rehabilitation in Rheumatology and including participants at four rheumatology hospital departments and five specialized rehabilitation institutions. Participants will thus be included from all four health regions in Norway.
The study has five points of assessment. In an electronic portal, delivered by CheckWare, patients will log in with their Bank ID and complete the core set of PROMs at admission, discharge, and 4, 8 and 12 months following discharge.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Admitted to rehabilitation at one of the nine participating rehabilitation centres with one of the following groups of diagnosis: Inflammatory rheumatic disease, Osteoarthritis, Low back pain, Neck/shoulder pain, Generalized pain syndromes (including fibromyalgia), Osteoporosis, Connective tissue diseases (SLE, Lupus, Myositis etc.), Fractures with need of rehabilitation, or Rehabilitation after orthopaedic surgery. Good proficiency in oral and written Norwegian language. Access to internet and BankID.
Exclusion Criteria:
- Cognitive impairment or severe mental illness.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Goal attainment
Time Frame: One year
|
Goal attainment will be measures by the Patient Specific Functional Scale.
Scale from 0 to 10, were 10 is the best score.
Mean score is calculated from all activites scored.
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health-realted quality of life
Time Frame: One year
|
Health-realted quality of life will be measured by the EQ5D
|
One year
|
Physical function
Time Frame: One year
|
Physical function will be measured by the 30 seconds sit to stand test
|
One year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General Pain
Time Frame: One year
|
Pain will be measured on a numeric rating scale (NRS).
Pain is measured on a subjective scale from 0 to 10, were 0 is no pain and 10 is the worst pain.
|
One year
|
Fatigue
Time Frame: One year
|
Fatigue will be measured on a numeric rating scale (NRS).
Fatigue is measured on a subjective scale from 0 to 10, were 0 is no fatiuge and 10 is the worst abount of fatigue.
|
One year
|
Motivation for goal attainment
Time Frame: One year
|
Motivation for goal attainment will be measured on a numeric rating scale (NRS).
Motivation is measured on a subjective scale from 0 to 10, were 0 is no motviation and 10 is the best and highest motivation.
|
One year
|
Function in daily acitvities
Time Frame: One year
|
Daily activities will be measured by the Hannover Functional Ability Questionnair
|
One year
|
Coping
Time Frame: One year
|
Coping will be measures by the Effective Musculoskeletal Consumer Scale.
The scale goes from 0 to 4, were 0 stated "never" and 4 states "always".
|
One year
|
Mental health
Time Frame: One year
|
Mental health will be measured by the Hopkins Symptoms Checklist
|
One year
|
Participation
Time Frame: One year
|
Participation will be measured by the participation scale in COOP/WONKA
|
One year
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Tore K Kvien, PhD, Diakonhjemmet Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Project nr. 97035
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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