Rehabilitation Trajectories | NCT03733847

Studies
Rehabilitation Trajectories

NCT03733847

Sponsor

National Resource Center for Rehabilitation in Rheumatology

Status

Completed

Last Update Posted

Oct 28, 2019Actual

Enrollment

524Actual

Phase

Not provided

Conditions

Musculoskeletal Disease

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2015Actual

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Dec 31, 2017Actual

First Submitted Date

Nov 6, 2018

First Submission Date that Met QC Criteria

Nov 6, 2018

First Posted Date

Nov 7, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2019

Last Update Posted Date

Oct 28, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ingvild Kjeken, Professor, National Resource Center for Rehabilitation in RheumatologyPrincipal Investigator

Lead Sponsor

National Resource Center for Rehabilitation in RheumatologyOTHER

Collaborators

Name	Class
Haugesund Rheumatism Hosptial AS	UNKNOWN
Betanien Hospital	OTHER
Vikersund Rehabilitation Center AS	UNKNOWN
Meråker Rehabilitation Center

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

524Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Health-realted quality of life	Health-realted quality of life will be measured by the EQ5D	One year
Physical function	Physical function will be measured by the 30 seconds sit to stand test

Other Outcomes

Measure	Description	Time Frame
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
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.

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tore K Kvien, PhD	Diakonhjemmet Hospital	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009140	Musculoskeletal Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided