Rehabilitation Trajectories

Sponsor

National Resource Center for Rehabilitation in Rheumatology (Other)

Overall Status

Completed

CT.gov ID

NCT03733847

Collaborator

Haugesund Rheumatism Hosptial AS (Other), Betanien Hospital (Other), Vikersund Rehabilitation Center AS (Other), Meråker Rehabilitation Center (Other), North Norway Rehabilitation Center (Other), UniCare Jeløy (Other), Sørlandet Hospital (Other), Innlandet HF Konsvinger Hospital (Other), Rehab Vest Rehabilitation Hospital (Other)

524

Enrollment

Actual Duration (Months)

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Musculoskeletal Disease

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 Design

Study Type:

Observational

Actual Enrollment :

524 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Dec 31, 2017

Actual Study Completion Date :

Dec 31, 2017

Outcome Measures

Primary Outcome Measures

Goal attainment [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.

Secondary Outcome Measures

Health-realted quality of life [One year]
Health-realted quality of life will be measured by the EQ5D
Physical function [One year]
Physical function will be measured by the 30 seconds sit to stand test

Other Outcome Measures

General Pain [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.
Fatigue [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.
Motivation for goal attainment [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.
Function in daily acitvities [One year]
Daily activities will be measured by the Hannover Functional Ability Questionnair
Coping [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".
Mental health [One year]
Mental health will be measured by the Hopkins Symptoms Checklist
Participation [One year]
Participation will be measured by the participation scale in COOP/WONKA

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Investigators

Study Director: Tore K Kvien, PhD, Diakonhjemmet Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ingvild Kjeken, Professor, National Resource Center for Rehabilitation in Rheumatology

ClinicalTrials.gov Identifier:

NCT03733847

Other Study ID Numbers:

Project nr. 97035

First Posted:

Nov 7, 2018

Last Update Posted:

Oct 28, 2019

Last Verified:

Oct 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Musculoskeletal Diseases

Study Results

No Results Posted as of Oct 28, 2019