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

Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03764982
• Other study ID #: 99008
• Secondary ID: DS-00040
• Status: Active, not recruiting
• Start date: January 2, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Diakonhjemmet Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3793
• Est. completion date: December 31, 2025
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rehabilitation

Locations

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

Sponsors (23)

Lead Sponsor

Collaborator

Diakonhjemmet Hospital

Åstveit rehabilitation center, AVONOVA Ringerike rehabilitation, Evjeklinikken, Helsepartner rehabilitation center, Hernes institute, HLF Briskeby rehabilitation center, Montebellosenteret, Muritunet as rehabilitation center, NKS Helsehus as, Norwegian National Advisory Unit on Rehabilitation in Rheumatology (NKRR), Norwegian National Centre for Occupational Rehabilitation (NKARR), Ravneberghaugen rehabilitation center, Regional Center of Knowledge Translation in Rehabilitation, Sunnaas rehabilitation hosp., REMEDY - Center for treatment of Rheumatic and Musculoskeletal Diseases, Røde Kors Haugland rehabilitation center, Røysumtunet rehabilitation center, Selli rehabilitation center, Skogli Health and Rehabilitation Center, Sørlandet rehabilitation center, Stiftelsen CatoSenteret rehabilitation center, Vikersund rehabilitation center and kurbad, VIRKE Rehab

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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
Primary	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