Clinical trial NCT03764982: RehabNytte - A Study of Rehabilitation Processes in Specialized Care in Norway
Official title: RehabNytte - A Multi Center Study in Specialized Rehabilitation Centers in Norway Exploring Health, Function, Workability and Quality of Life Following Rehabilitation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rehabilitation
Keywords: Rehabilitation
Multidisciplinary
Health care
*the RehabNytte Consortium
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
Collaborators: name: VIRKE Rehab
name: Norwegian National Centre for Occupational Rehabilitation (NKARR)
name: Regional Center of Knowledge Translation in Rehabilitation, Sunnaas rehabilitation hosp.
name: Skogli Health and Rehabilitation Center
name: Stiftelsen CatoSenteret rehabilitation center
name: HLF Briskeby rehabilitation center
name: Vikersund rehabilitation center and kurbad
name: Røysumtunet rehabilitation center
name: Evjeklinikken
name: Montebellosenteret
name: Muritunet as rehabilitation center
name: Røde Kors Haugland rehabilitation center
name: Sørlandet rehabilitation center
name: AVONOVA Ringerike rehabilitation
name: Hernes institute
name: NKS Helsehus as
name: Ravneberghaugen rehabilitation center
name: Åstveit rehabilitation center
name: Selli rehabilitation center
name: Helsepartner rehabilitation center
name: Norwegian National Advisory Unit on Rehabilitation in Rheumatology (NKRR)
name: REMEDY - Center for treatment of Rheumatic and Musculoskeletal Diseases
First posted: 2018-12-05
Enrollment: 3793
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: The EuroQoL-5D-5L
timeFrame: 1-3 minutes
measure: The EuroQoL-VAS health
timeFrame: 1-2 minutes
measure: The Patient Specific Functional Scale (PSFS)
timeFrame: 2-6 minutes
measure: PROMIS 29
timeFrame: 5-10 minutes
Secondary outcomes:
Other outcomes:
measure: The MUSS Quality Indicator set for Rehabilitation
timeFrame: 3-8 minutes
Locations:
city: Alta
country: Norway
facility: Helsepartner rehabilitation centre
city: Bergen
country: Norway
facility: Åstveit rehabilitation centre
city: Eiken
country: Norway
facility: Sørlandet rehabilitation centre
city: Evje
country: Norway
facility: Evjeklinikken rehabilitation centre
city: Flekke
country: Norway
facility: Red Cross Haugland rehabilitation centre
city: Hagavik
country: Norway
facility: Ravneberghaugen rehabilitation centre
city: Hernes
country: Norway
facility: Hernes institutt
city: Hønefoss
country: Norway
facility: AVONOVA Ringerike rehabilitation centre
city: Jaren
country: Norway
facility: Røysumtunet rehabiliteringssenter
city: Klæbu
country: Norway
facility: Selli rehabilitation centre
city: Lier
country: Norway
facility: HLF Briskeby rehabilitation centre
city: Lillehammer
country: Norway
facility: Montebellosenteret
city: Lillehammer
country: Norway
facility: Skogli rehabilitation centre
city: Lørenskog
country: Norway
facility: NKS Helsehus
city: Son
country: Norway
facility: CatoSenteret
city: Valldal
country: Norway
facility: Muritunet rehabilitation centre
city: Vikersund
country: Norway
facility: Vikersund rehabilitation centre
Study officials:
affiliation: Dep.Rheumatology, Diakonhjemmet hospital
name: Tore K Kvien, Professor
role: STUDY_DIRECTOR
References: