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Trial record 2 of 3376 for:    rehabilitation

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

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ClinicalTrials.gov Identifier: NCT03764982
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : February 8, 2019
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
Stamina Ringerike rehabilitation
Hernes institute
NKS Helsehus as
Ravneberghaugen rehabilitation center
Åstveit rehabilitation center
Selli rehabilitation center
Finnmark rehabilitation center (OIF)
Information provided by (Responsible Party):
Mari Klokkerud, Diakonhjemmet Hospital

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, 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 centre from Norway. 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. Quality assessment (use of Quality indicator set)
  4. Measurement characteristics (feasibility and responsiveness) of recommended PROMS in rehabilitation

Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: RehabNytte. Health, Function, Workability and Quality of Life Following Rehabilitation. A Multi Center Study in Specialized Rehabilitation Centers in Norway
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation




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.



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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.

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


Contacts
Contact: Mari Klokkerud, PhD +4793085556 mari.klokkerud@diakonsyk.no
Contact: Rikke H Moe, PhD +4792454587 rikkehelene.moe@diakonsyk.no

Locations
Norway
Finnmark rehabilitation centre Recruiting
Alta, Norway
Contact: Eirik L Irgens    47976 00 200    eirik.irgens@oif.no   
Åstveit rehabilitation centre Recruiting
Bergen, Norway
Contact: Tone O Kallekleiv    4755539790    tone@adm.astveithelsesenter.no   
Sørlandet rehabilitation centre Recruiting
Eiken, Norway
Contact: Rita Jonasmo    38349400    rita.jonasmo@sorrehab.no   
Evjeklinikken rehabilitation centre Recruiting
Evje, Norway
Contact: Jostein Sæle    4796908122    js@evjeklinikken.no   
Red Cross Haugland rehabilitation centre Recruiting
Flekke, Norway
Contact: Anette B Wolff    4791623378    Anette.wolff@staff.rcnuwc.no   
Ravneberghaugen rehabilitation centre Recruiting
Hagavik, Norway
Contact: Silje L Soldal    40299535    Silje.soldal@ravneberghaugen.no   
Hernes institutt Recruiting
Hernes, Norway
Contact: Tonje J Johnsen, BSc    4762422400    tonjejossie@hernesinstitutt.no   
Stamina Ringerike rehabilitation centre Recruiting
Hønefoss, Norway
Contact: Idun Eid, BSc    4793025127    idun.eid@staminagroup.no   
Røysumtunet rehabiliteringssenter Recruiting
Jaren, Norway
Contact: Heidi H Framstad, BSc    48 11 83 30    hf@roysumtunet.no   
Selli rehabilitation centre Recruiting
Klæbu, Norway
Contact: Christian Hoff    4772834300    christian.hoff@selli.no   
HLF Briskeby rehabilitation centre Recruiting
Lier, Norway
Contact: Johanne Fossen    47977556    johanne.fossen@hlfbriskeby.no   
Montebellosenteret Recruiting
Lillehammer, Norway
Contact: Gunnhild Gjerset, PhD    4795726176    gunhg@ous-hf.no   
Skogli rehabilitation centre Recruiting
Lillehammer, Norway
Contact: Anders Orpana    4761249217    Anders.orpana@skogli.no   
NKS Helsehus Recruiting
Lørenskog, Norway
Contact: Nina Lillehagen    4795821078    nina@nks-helsehus.no   
CatoSenteret Recruiting
Son, Norway
Contact: Hege Bruun-Hanssen, BSc    4790063470    Hege.bruun-hanssen@catosenteret.no   
Muritunet rehabilitation centre Recruiting
Valldal, Norway
Contact: Anniken    4779258389    anniken.hjellbakk.hole@muritunet.no   
Vikersund rehabilitation centre Recruiting
Vikersund, Norway
Contact: Annette L Granberg    99366956    anette.granberg@vikersundbad.no   
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
Stamina Ringerike rehabilitation
Hernes institute
NKS Helsehus as
Ravneberghaugen rehabilitation center
Åstveit rehabilitation center
Selli rehabilitation center
Finnmark rehabilitation center (OIF)
Investigators
Study Director: Tore K Kvien, Professor Dep.Rheumatology, Diakonhjemmet hospital

Responsible Party: Mari Klokkerud, Project leader, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier: NCT03764982     History of Changes
Other Study ID Numbers: 99008
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mari Klokkerud, Diakonhjemmet Hospital:
Rehabilitation
Multidisciplinary
Health care