NCT02369055

Brief Summary

The aim of this study is to analyze and describe rehabilitation pathways of stroke patients in a region of North Norway and Central Denmark Region in relation to how patients perceive quality of life, health and functioning one year post stroke. The study will consist of 1) Translate, cross-cultural adapt and validate a stroke-specific health-related questionnaire 2) Describe the level of quality of life and rehabilitation pathway in the two countries 3) In-depth interviews of a smaller group of patients for a more complex understanding The study is part of a larger prospective observational multicenter-study of two patient cohorts with stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
369

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
completed

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 15, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 23, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2019

Completed
Last Updated

December 4, 2019

Status Verified

November 1, 2019

Enrollment Period

2.9 years

First QC Date

January 13, 2015

Last Update Submit

December 2, 2019

Conditions

Keywords

Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Health-Related Quality of Life

    The Stroke-Specific Quality of Life (SS-QOL) scale

    one year

Study Arms (2)

Stroke survivors in North Norway

Patients with ischemic or heamorrhagic stroke admitted to stroke units in UNN Tromso, Narvik or Harstad (Norway), and living in the defined geographic area of these 3 hospitals.

Stroke survivors in Denmark

Patients with ischemic og heamorrhagic stroke admitted to a stroke unit in Aarhus University Hospital and living in the municipalities of Randars or Favrskov in Central Denmark Region

Eligibility Criteria

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

All patients with stroke

You may qualify if:

  • All patients admitted to the hospitals; UNN Tromso,Harstad, Narvik (Norway) and Aarhus (Denmark).

You may not qualify if:

  • Unverified stroke and residence outside of the studyregion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitetet i Tromsø, Norges Arktiske Universitet, Det helsevitenskapelige fakultet, Institutt for helse og omsorgsfag

Tromsø, 9037, Norway

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Audny Anke, PhD

    Division of Rehabilitation Services, University Hospital of North

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2015

First Posted

February 23, 2015

Study Start

March 15, 2014

Primary Completion

January 31, 2017

Study Completion

October 25, 2019

Last Updated

December 4, 2019

Record last verified: 2019-11

Locations