NCT02311426

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

November 2, 2021

Status Verified

October 1, 2021

Enrollment Period

8.5 years

First QC Date

December 4, 2014

Last Update Submit

October 25, 2021

Conditions

Keywords

Rehabilitation; Functional outcome

Outcome Measures

Primary Outcomes (2)

  • Rehabilitation Needs

    Not enough help or training

    3 months post-stroke

  • Health related Quality of life questionnaire

    Qolibri\_OS

    3 and 12 months post-stroke

Study Arms (2)

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

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

Interventions

Function, health related quality of life and rehabilitation needs will be analysed in the two country region groups

DenmarkNorway

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Verified stroke. Admitted to stroke unit.

You may not qualify if:

  • Patients outside the regions excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, 9016, Norway

Location

MeSH Terms

Conditions

Stroke

Interventions

Observation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Audny Anke, MD PhD

    University Hospital of North Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Professor

Study Record Dates

First Submitted

December 4, 2014

First Posted

December 8, 2014

Study Start

March 1, 2014

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

November 2, 2021

Record last verified: 2021-10

Locations