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

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ClinicalTrials.gov Identifier: NCT02369055
Recruitment Status : Active, not recruiting
First Posted : February 23, 2015
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital of North Norway

Brief Summary:

The aim of this study is to analyze and describe rehabilitation pathways of stroke patients in northern Norway and Denmark in relation to how patients describe their health-related quality of life one year post stroke.

The study will consist of 1) Translate, cross-cultural adapt and validate a 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.


Condition or disease
Stroke Quality of Life

Detailed Description:

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, SSQoL (-DK and -NO), HADS, EQ-5D, QOLIBRI-OS 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 ans 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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Relationship Between Quality of Life and Rehabilitation Pathway One Year Post Stroke in Northern Norway and Denmark. A Mixed Method Study.
Actual Study Start Date : March 2014
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Group/Cohort
Patients with stroke

All patients from UNN Tromso, Narvik and Harstad (Norway) and Aarhus (Denmark) are included.

For the in-depth interviews patients are strategically picked based on their answers in the quantitative study




Primary Outcome Measures :
  1. Quality of Life [ Time Frame: one year ]
    The questionnaire includes demographic data, SSQoL (-DK and -NO), HADS, EQ-5D, QOLIBRI-OS and additional questions about satisfaction on treatment and rehabilitation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with stroke
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Unverified stroke and residence outside of the studyregion.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02369055


Locations
Norway
Universitetet i Tromsø, Norges Arktiske Universitet, Det helsevitenskapelige fakultet, Institutt for helse og omsorgsfag
Tromsø, Norway, 9037
Sponsors and Collaborators
University Hospital of North Norway
Investigators
Study Chair: Audny Anke, PhD Division of Rehabilitation Services, University Hospital of North

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT02369055     History of Changes
Other Study ID Numbers: SFP1174-14
First Posted: February 23, 2015    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: January 2017

Keywords provided by University Hospital of North Norway:
Rehabilitation

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases