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

• Sponsor: University Hospital of North Norway (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02311426
• Collaborator: St. Olavs Hospital (Other)
• Enrollment: 1,000
• Location: 1
• Duration (Months): 102
• Patients Per Site Per Month: 9.8

Study Details

Study Description

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 functional status, health related quality of life and rehabilitation needs. Information about rehabilitation services in both countries are collected and compared, and analysed in relation to patients outcome.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Other: Observational study

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Stroke in North of Norway and Denmark. A Prospective Cohort Study.
• Study Start Date: Mar 1, 2014
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

Arm	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. At baseline 155 patients with first ever stroke were registered. At 3 and 12 months follow-up 135-155 patients were enrolled.	Other: Observational study; Function, health related quality of life and rehabilitation needs will be analysed in the two country region groups
Denmark 500 consecutive patients from the stroke unit at Århus Hospital in Denmark. At baseline 402 patients with first ever stroke were included. At 3 and 12 months follow-up 318/ 170 patients were enrolled.	Other: Observational study; Function, health related quality of life and rehabilitation needs will be analysed in the two country region groups

Outcome Measures

Primary Outcome Measures

1. Rehabilitation Needs [3 months post-stroke]

   Not enough help or training

2. Health related Quality of life questionnaire [3 and 12 months post-stroke]

   Qolibri_OS

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Verified stroke. Admitted to stroke unit.

Exclusion Criteria:

• Patients outside the regions excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of North Norway	Tromsø		Norway	9016

Sponsors and Collaborators

• University Hospital of North Norway
• St. Olavs Hospital

Investigators

• Principal Investigator: Audny Anke, MD PhD, University Hospital of North Norway

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Audny Anke, MD, PhD, Professor, University Hospital of North Norway
• ClinicalTrials.gov Identifier: NCT02311426
• Other Study ID Numbers: SFP1175-14
• First Posted: Dec 8, 2014
• Last Update Posted: Nov 2, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by Audny Anke, MD, PhD, Professor, University Hospital of North Norway: Rehabilitation; Functional outcome
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Nov 2, 2021