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

NCT ID: NCT02369055

Last Updated: 2019-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

369 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-15

Study Completion Date

2019-10-25

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital of North Norway

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Audny Anke, PhD

Role: STUDY_CHAIR

Division of Rehabilitation Services, University Hospital of North

Locations

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

Tromsø, , Norway

Site Status

Countries

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Norway

Other Identifiers

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SFP1174-14

Identifier Type: -

Identifier Source: org_study_id

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