Rehabilitation Trajectories

Musculoskeletal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03733847
• Other study ID #: Project nr. 97035
• Status: Completed
• Start date: November 1, 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: October 2019
• Source: National Resource Center for Rehabilitation in Rheumatology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 524
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Musculoskeletal Disease
• Musculoskeletal Diseases

Locations

Country	Name	City	State
n/a

Sponsors (10)

Lead Sponsor	Collaborator
National Resource Center for Rehabilitation in Rheumatology	Betanien Hospital, Haugesund Rheumatism Hosptial AS, Innlandet HF Konsvinger Hospital, Meråker Rehabilitation Center, North Norway Rehabilitation Center, Rehab Vest Rehabilitation Hospital, Sørlandet Hospital, UniCare Jeløy, Vikersund Rehabilitation Center AS

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	General Pain	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
Other	Fatigue	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
Other	Motivation for goal attainment	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
Other	Function in daily acitvities	Daily activities will be measured by the Hannover Functional Ability Questionnair	One year
Other	Coping	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
Other	Mental health	Mental health will be measured by the Hopkins Symptoms Checklist	One year
Other	Participation	Participation will be measured by the participation scale in COOP/WONKA	One year
Primary	Goal attainment	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	Health-realted quality of life	Health-realted quality of life will be measured by the EQ5D	One year
Secondary	Physical function	Physical function will be measured by the 30 seconds sit to stand test	One year