Stroke and Rehabilitation in North of Norway and Central Denmark

Sponsor

University Hospital of North Norway (Other)

Overall Status

Unknown status

CT.gov ID

NCT03948906

Collaborator

Regionshospitalet Hammel Neurocenter (Other)

815

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

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 :

Apr 1, 2014

Anticipated Primary Completion Date :

Jul 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Outcome Measures

Primary Outcome Measures

HRQOL [2014- 2016]
HRQOL measured by QOLIBRI-OS

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital of North Norway
Regionshospitalet Hammel Neurocenter

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

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

Last Update Posted:

Mar 2, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Audny Anke, Professor, University Hospital of North Norway

Stroke

Observational study

Rehabilitation

Health related quality of life

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Mar 2, 2020