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

Stroke Clinical Trial

Official title:

Relationship Between Quality of Life and Rehabilitation Pathway One Year Post Stroke in Northern Norway and Denmark. A Mixed Method Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02369055
• Other study ID #: SFP1174-14
• Status: Completed
• Start date: March 15, 2014
• Est. completion date: October 25, 2019

Study information

• Verified date: November 2019
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 369
• Est. completion date: October 25, 2019
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Quality of Life
• Stroke

Locations

Country	Name	City	State
Norway	Universitetet i Tromsø, Norges Arktiske Universitet, Det helsevitenskapelige fakultet, Institutt for helse og omsorgsfag	Tromsø

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-Related Quality of Life	The Stroke-Specific Quality of Life (SS-QOL) scale	one year