RehabNytte - A Study of Rehabilitation Processes in Specialized Care in Norway

RehabNytte - A Multi Center Study in Specialized Rehabilitation Centers in Norway Exploring Health, Function, Workability and Quality of Life Following Rehabilitation

The main objective of the study is to describe function and health related to quality of life during the first year after rehabilitation, to measure the degree and impact of user involvement in the rehabilitation process, assess factors associated with change in work -ability and -participation, and to test measurement properties of a new core set of outcome measures for rehabilitation launched by the Norwegian Directorate of Health.

Study Overview

• Status: Active, not recruiting
• Conditions: Rehabilitation

Detailed Description

This is a large multicentre cohort study including patients receiving rehabilitation at 17 rehabilitation centres from Norway, *the RehabNytte Consortium. Invitation and registration of participants will be conducted by local project coordinators in the period between 01.01.2019 and 31.03.2020.

All participants will receive rehabilitation as usual at each centre, and report HRQoL, health and function (by PROMS) through a digital self-reporting system at admission, discharge and after 3, 6 and 12 months.

This study seeks to answer several research questions related to the overarching areas:

1. Patient reported change of function, health and quality of life during the first year after rehabilitation
2. Degree of user involvement in rehabilitation
3. Change in work -ability and -participation
4. Quality assessment (use of Quality indicator set)
5. Measurement characteristics (feasibility and responsiveness) of recommended PROMS in rehabilitation

• Study Type: Observational
• Enrollment (Actual): 3793

Contacts and Locations

Study Locations

• Norway
  • Alta, Norway
    • Helsepartner rehabilitation centre
  • Bergen, Norway
    • Åstveit rehabilitation centre
  • Eiken, Norway
    • Sørlandet rehabilitation centre
  • Evje, Norway
    • Evjeklinikken rehabilitation centre
  • Flekke, Norway
    • Red Cross Haugland rehabilitation centre
  • Hagavik, Norway
    • Ravneberghaugen rehabilitation centre
  • Hernes, Norway
    • Hernes institutt
  • Hønefoss, Norway
    • AVONOVA Ringerike rehabilitation centre
  • Jaren, Norway
    • Røysumtunet rehabiliteringssenter
  • Klæbu, Norway
    • Selli rehabilitation centre
  • Lier, Norway
    • HLF Briskeby rehabilitation centre
  • Lillehammer, Norway
    • Montebellosenteret
  • Lillehammer, Norway
    • Skogli rehabilitation centre
  • Lørenskog, Norway
    • NKS Helsehus
  • Son, Norway
    • CatoSenteret
  • Valldal, Norway
    • Muritunet rehabilitation centre
  • Vikersund, Norway
    • Vikersund rehabilitation centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

• Patients receiving rehabilitation at seventeen rehabilitation centres in specialist care (all health regions)
• All diagnoses, with largest groups of musculoskeletal diseases, neurological conditions (stroke, MS), cancer, and heart- and lunge conditions.

Description

Inclusion Criteria:

• Patients that participates in inpatient or outpatient rehabilitation programs at one of the participating centers.
• Age over 18 years
• Access to internet at home
• Access to personal secure login with BANK ID.

Exclusion Criteria:

• Severely reduced cognitive function
• severe mental illness with inadequate consent competence ability to participate
• Insufficient understanding of Norwegian written language.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The EuroQoL-5D-5L	5-item questionnaire assessing function and health in walking, ADL, personal care, pain/discomfort and anxiety/depression. Sores could be calculated both as numbers and 'utilities'.	1-3 minutes
The EuroQoL-VAS health	The EUROQUOL 5D-5L includes a 100 mm VAS scale/thermometer. Index value: 0-1, 1 is best VAS gen health: 0-100, 100 is best	1-2 minutes
The Patient Specific Functional Scale (PSFS)	Patient-specific instrument. Up to five activities are described by the patient, and scored according to experienced performance (0-10, 10 is best).	2-6 minutes
PROMIS 29	The PROMIS-29, a generic health-related quality of life survey, assesses each of the 7 PROMIS domains (depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; and ability to participate in social roles and activities) with 4 questions. The questions are ranked on a 5-point Likert Scale. There is also one 11-point rating scale for pain intensity.	5-10 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The MUSS Quality Indicator set for Rehabilitation	This Quality Indicator assessment tool consist of two separate questionnaires answered by rehabilitation managers and patients, and each questionnaire consist of 10 and 11 questions respectively. The quality indicators are originally developed for use in Rheumatic and musculoskeletal disorders (RMDs) has been developed and pilot tested according to the Rand/UCLA Appropriateness Method. In this study the set will be tested in a generic population.	3-8 minutes

Collaborators and Investigators

• Sponsor: Diakonhjemmet Hospital
• Collaborators: VIRKE Rehab; Norwegian National Centre for Occupational Rehabilitation (NKARR); Regional Center of Knowledge Translation in Rehabilitation, Sunnaas rehabilitation hosp.; Skogli Health and Rehabilitation Center; Stiftelsen CatoSenteret rehabilitation center; HLF Briskeby rehabilitation center; Vikersund rehabilitation center and kurbad; Røysumtunet rehabilitation center; Evjeklinikken; Montebellosenteret; Muritunet as rehabilitation center; Røde Kors Haugland rehabilitation center; Sørlandet rehabilitation center; Hernes institute; NKS Helsehus as; Ravneberghaugen rehabilitation center; Åstveit rehabilitation center; Selli rehabilitation center; AVONOVA Ringerike rehabilitation; Helsepartner rehabilitation center; Norwegian National Advisory Unit on Rehabilitation in Rheumatology (NKRR); REMEDY - Center for treatment of Rheumatic and Musculoskeletal Diseases
• Investigators: Study Director: Tore K Kvien, Professor, Dep.Rheumatology, Diakonhjemmet hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Actual): March 31, 2021
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 23, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Health care; Multidisciplinary; *the RehabNytte Consortium
• Other Study ID Numbers: 99008; DS-00040 (Registry Identifier: Data protection approval)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Participating centres will have access to de-identificated IPD after the data collection period is completed. Data will only be shared with other researchers after approval by the steering committee, and in line with the purposes of the project.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No