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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03764982
Recruitment Status : Active, not recruiting
First Posted : December 5, 2018
Last Update Posted : October 2, 2023
Sponsor:
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
AVONOVA Ringerike rehabilitation
Hernes institute
NKS Helsehus as
Ravneberghaugen rehabilitation center
Åstveit rehabilitation center
Selli rehabilitation center
Helsepartner rehabilitation center
Norwegian National Advisory Unit on Rehabilitation in Rheumatology (NKRR)
REMEDY - Center for treatment of Rheumatic and Musculoskeletal Diseases
Information provided by (Responsible Party):
Rikke Helene Moe, Diakonhjemmet Hospital

Study Description
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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.

Condition or disease
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 Design
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Study Type : Observational
Actual Enrollment : 3793 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: RehabNytte - A Multi Center Study in Specialized Rehabilitation Centers in Norway Exploring Health, Function, Workability and Quality of Life Following Rehabilitation
Actual Study Start Date : January 2, 2019
Actual Primary Completion Date : March 31, 2021
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. The EuroQoL-5D-5L [ Time Frame: 1-3 minutes ]
    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'.

  2. The EuroQoL-VAS health [ Time Frame: 1-2 minutes ]
    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

  3. The Patient Specific Functional Scale (PSFS) [ Time Frame: 2-6 minutes ]
    Patient-specific instrument. Up to five activities are described by the patient, and scored according to experienced performance (0-10, 10 is best).

  4. PROMIS 29 [ Time Frame: 5-10 minutes ]
    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.


Other Outcome Measures:
  1. The MUSS Quality Indicator set for Rehabilitation [ Time Frame: 3-8 minutes ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03764982


Locations
Show Show 17 study locations
Sponsors and Collaborators
Diakonhjemmet Hospital
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
AVONOVA Ringerike rehabilitation
Hernes institute
NKS Helsehus as
Ravneberghaugen rehabilitation center
Åstveit rehabilitation center
Selli rehabilitation center
Helsepartner rehabilitation center
Norwegian National Advisory Unit on Rehabilitation in Rheumatology (NKRR)
REMEDY - Center for treatment of Rheumatic and Musculoskeletal Diseases
Investigators
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Study Director: Tore K Kvien, Professor Dep.Rheumatology, Diakonhjemmet hospital
More Information
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Responsible Party: Rikke Helene Moe, Principal Investigator, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier: NCT03764982    
Other Study ID Numbers: 99008
DS-00040 ( Registry Identifier: Data protection approval )
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: October 2, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rikke Helene Moe, Diakonhjemmet Hospital:
Rehabilitation
Multidisciplinary
Health care
*the RehabNytte Consortium