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Stroke in North of Norway and Denmark. A Prospective Cohort Study.

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: NCT02311426
Recruitment Status : Unknown
Verified December 2014 by Audny Anke, University Hospital of North Norway.
Recruitment status was:  Recruiting
First Posted : December 8, 2014
Last Update Posted : December 8, 2014
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Audny Anke, University Hospital of North Norway

Brief Summary:
The study is a comparative effectiveness study with comparision of two cohorts of patients with stroke in North of Norway and in Denmark. At baseline information is collected from the stroke registries in both countries. Time points for follow up are at 3 and 12 months post-stroke. Data are collected from medical charts and with use of telephone interview in addition to self-report questionnaires. The study will provide information about mortality, functional status and quality of life. Information about rehabilitation services in both countries are collected and compared, and analysed in relation to patients outcome.

Condition or disease Intervention/treatment
Stroke Other: Observational study

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Study Start Date : March 2014
Estimated Primary Completion Date : September 2016

Group/Cohort Intervention/treatment
Norway
500 consecutive patients with stroke from the stroke units at the University Hospital of North Norway located in the cities Narvik, Harstad and Tromsø.
Other: Observational study
Denmark
500 consecutive patients from the stroke unit at Århus Hospital in Denmark.
Other: Observational study



Primary Outcome Measures :
  1. Modified Rankin Scale [ Time Frame: 12 months ]
  2. Quality of life questionnaire [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 3 months ]


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
Patients with stroke admitted to the stroke units at the University Hospital of North Norway and Århus Hospital in Denmark
Criteria

Inclusion Criteria:

  • Verified stroke. Admitted to stroke unit.

Exclusion Criteria:

  • Patients outside the regions included.

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): NCT02311426


Contacts
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Contact: Audny Anke, MD, PhD +47 95936333 audny.anke@unn.no
Contact: Guri Heiberg, MD, MBA +4795948500 guri.heiberg@unn.no

Locations
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Norway
University Hospital of North Norway Recruiting
Tromsø, Norway, 9016
Contact: Audny Anke, MD, PhD    +47 95936333    audny.anke@uit.no   
Contact: Guri Heiberg, MD, MBA    +4795948500    guri.heiberg@unn.no   
Sponsors and Collaborators
University Hospital of North Norway
St. Olavs Hospital
Additional Information:

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Responsible Party: Audny Anke, MD, PhD, Associated professor, University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT02311426    
Other Study ID Numbers: SFP1175-14
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014
Keywords provided by Audny Anke, University Hospital of North Norway:
Rehabilitation; Functional outcome
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases