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Stroke and Rehabilitation in North of Norway and Central Denmark

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: NCT03948906
Recruitment Status : Active, not recruiting
First Posted : May 14, 2019
Last Update Posted : March 2, 2020
Sponsor:
Collaborator:
Regionshospitalet Hammel Neurocenter
Information provided by (Responsible Party):
Audny Anke, University Hospital of North Norway

Brief Summary:
Post-stroke prospective multicenter cohort study. The objectives of the study was to compare functioning and health related quality of life in the two study regions, in relation to known predictors and to differences in organization of treatment- and rehabilitation. The inclusion was of consecutive acute stroke patients with ICD10 diagnosis I.63 and I.61 from a regional part of Northern Norway and Jylland Denmark. All were referred to stroke units. At baseline national stroke registry data were collected in each country. A questionnaire package was mailed to the participants 3- and 12-months post stroke. Telephone interviews at 3 months post stroke added information on functioning and rehabilitation.

Condition or disease
Stroke, Acute

Detailed Description:

Post-stroke prospective multicenter cohort study. The objectives of the study was to compare functioning and health related quality of life in the two study regions, in relation to known predictors and to differences in organization of treatment- and rehabilitation. The inclusion was of consecutive acute stroke patients with ICD10 diagnosis I.63 and I.61 from a regional part of Northern Norway and Jylland Denmark. All were referred to stroke units. At baseline national stroke registry data were collected in each country. Telephone interviews at 3 months post stroke added information on functioning and rehabilitation. A questionnaire package was mailed to the participants 3- and 12-months post stroke. These included validated Questionnaires like QOLIBRI-OS, HADS, SS-QOL and EQ5D.

Validity studies on QOLIBRI-OS and SS-QOL has been published.

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Study Type : Observational
Actual Enrollment : 815 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparing Post-stroke Functioning and Rehabilitation Pathways in a Region of North of Norway and a Region of Denmark. A Prospective Cohort Study.
Actual Study Start Date : April 2014
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation




Primary Outcome Measures :
  1. HRQOL [ Time Frame: 2014- 2016 ]
    HRQOL measured by QOLIBRI-OS



Information from the National Library of Medicine

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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:   Probability Sample
Study Population
Adult patients with ischemic or hemorrhagic stroke
Criteria
  • Clinical diagnosis acute ischemic or hemmorhagic stroke
  • Inclusion period Mars 2014 to January 2016
  • Hospitalised in Stroke Units
  • Living in a defined geographic area in North of Norway or in Central Denmark
Publications of Results:
Other Publications:
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Responsible Party: Audny Anke, Professor, University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT03948906    
Other Study ID Numbers: SF 1175-14NCT02311426
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Audny Anke, University Hospital of North Norway:
Stroke
Observational study
Rehabilitation
Health related quality of life
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases