Rehabilitation Trajectories

October 25, 2019 updated by: Ingvild Kjeken, National Resource Center for Rehabilitation in Rheumatology

Rehabilitation Trajectories. A Study of Rehabilitation Processes Across Health Care Levels in Patients With Rheumatic and Musculoskeletal Diseases

The main aim of this multicentre cohort study is to provide evidence that can be used to improve continuity and quality in rehabilitation practice and rehabilitation processes across health care levels for patients with rheumatic and musculoskeletal diseases (RMDs).

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

524

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with rheumatic and musculoskeletal diseases from Norway admitted to rehabilitation at one of the nine participating rehabilitation centres.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

November 6, 2018

First Submitted That Met QC Criteria

November 6, 2018

First Posted (Actual)

November 7, 2018

Study Record Updates

Last Update Posted (Actual)

October 28, 2019

Last Update Submitted That Met QC Criteria

October 25, 2019

Last Verified

October 1, 2019

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

No

Studies a U.S. FDA-regulated device product

No

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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