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CompletedNCT02369055Updated Dec 4, 2019

Quality of Life and Rehabilitation Pathway in Northern Norway and Denmark.

An observational study in Stroke and Quality of Life, sponsored by University Hospital of North Norway. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-04.

Sponsored by University Hospital of North Norway · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
369
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Anticipated: 500 patients from Norway and 500 patients from Denmark are included in the national stroke-register datasets, and 250 patients from each country in the questionnaire-based datasets.

The questionnaire includes demographic data, the Stroke-Specific Quality of Life (SS-QOL) scale, Hospital Anxiety and Depression Scale (HADS), The EuroQol Quality of Life scale (EQ-5D), the EuroQol Visual Analogue Scale (EQ-VAS), the Quality of Life After Brain Injury, Overall Scale QOLIBRI-OS, modified Rankin Scale (mRS), and additional questions about satisfaction on treatment and rehabilitation.

5-6 patients from each country will be selected for semi-structured interviews with both priori questions and exploratory questions.

The mixing of methods will balance the goals of generality and complex understanding in how patients describe their quality of life and rehabilitation-chain.

02

Conditions studied

  • Stroke
  • Quality of Life

Keywords

  • Rehabilitation
03

In context

Lead sponsor

University Hospital of North Norway is the lead sponsor of 151 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients with stroke

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Unverified stroke and residence outside of the studyregion.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
369 participants (actual)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Health-Related Quality of Life

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

    Time frame: one year

07

Study locations

1 site
  • Universitetet i Tromsø, Norges Arktiske Universitet, Det helsevitenskapelige fakultet, Institutt for helse og omsorgsfag
    Tromsø, 9037, Norway
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02369055
Lead sponsor
University Hospital of North Norway
Responsible party
Sponsor
First posted
Feb 23, 2015
Start date
Mar 15, 2014
Primary completion
Jan 31, 2017
Completion
Oct 25, 2019
Last update
Dec 4, 2019

Study contacts

Audny Anke, PhD
study chair · Division of Rehabilitation Services, University Hospital of North

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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