Stroke and Rehabilitation in North of Norway and Central Denmark

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

Tracking Information

• First Submitted Date: May 10, 2019
• First Posted Date: May 14, 2019
• Last Update Posted Date: March 2, 2020
• Actual Study Start Date: April 2014
• Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 10, 2019)

HRQOL [ Time Frame: 2014- 2016 ]

HRQOL measured by QOLIBRI-OS

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Stroke and Rehabilitation in North of Norway and Central Denmark
• 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.
• 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.

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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Adult patients with ischemic or hemorrhagic stroke
• Condition: Stroke, Acute
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

Publications *

• Pedersen SG, Heiberg GA, Nielsen JF, Friborg O, Stabel HH, Anke A, Arntzen C. Validity, reliability and Norwegian adaptation of the Stroke-Specific Quality of Life (SS-QOL) scale. SAGE Open Med. 2018 Jan 8;6:2050312117752031. doi: 10.1177/2050312117752031. eCollection 2018.
• Heiberg G, Pedersen SG, Friborg O, Nielsen JF, Holm HS, Steinbüchel von N, Arntzen C, Anke A. Can the health related quality of life measure QOLIBRI- overall scale (OS) be of use after stroke? A validation study. BMC Neurol. 2018 Jul 18;18(1):98. doi: 10.1186/s12883-018-1101-9.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: May 10, 2019): 815
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: December 2020
• Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03948906
• Other Study ID Numbers: SF 1175-14NCT02311426
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Audny Anke, University Hospital of North Norway
• Study Sponsor: University Hospital of North Norway
• Collaborators: Regionshospitalet Hammel Neurocenter
• Investigators: Not Provided
• PRS Account: University Hospital of North Norway
• Verification Date: February 2020