StrokeNCT02369055
Quality of Life and Rehabilitation Pathway in Northern Norway and Denmark.
An observational study of Stroke and Quality of Life, run by University Hospital of North Norway at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Quality of Life
- How many people
- 369 participants
- Where
- 1 siteNorway
- Study dates
- 15 Mar 2014to 25 Oct 2019
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with stroke
Who may be able to join
- All patients admitted to the hospitals; UNN Tromso,Harstad, Narvik (Norway) and Aarhus (Denmark).
Who cannot join
- Unverified stroke and residence outside of the studyregion.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Universitetet i Tromsø, Norges Arktiske Universitet, Det helsevitenskapelige fakultet, Institutt for helse og omsorgsfag
Tromsø, 9037
About this study
Official title: Relationship Between Quality of Life and Rehabilitation Pathway One Year Post Stroke in Northern Norway and Denmark. A Mixed Method Study.
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.
- Conditions
- Stroke, Quality of Life
- Keywords
- Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-Related Quality of Life
The Stroke-Specific Quality of Life (SS-QOL) scale
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study start15 Mar 2014
- Primary completion31 Jan 2017
- Study completion25 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 369 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Audny Anke, PhD, Study chair, Division of Rehabilitation Services, University Hospital of North
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369055
- Sponsor's protocol ID
- SFP1174-14
- Status last verified
- Nov 2019
- First submitted
- 13 Jan 2015
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Quality of Life and Rehabilitation Pathway One Year Post Stroke in Northern Norway and Denmark. A Mixed Method Study.
- ClinicalTrials.gov ID
- NCT02369055
- Acronym / sponsor ID
- SFP1174-14
- Conditions
- Stroke, Quality of Life
- Keywords
- Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- 15 Mar 2014 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 23 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with stroke
Key inclusion criteria (1 listed)
- All patients admitted to the hospitals; UNN Tromso,Harstad, Narvik (Norway) and Aarhus (Denmark).
Key exclusion criteria (1 listed)
- Unverified stroke and residence outside of the studyregion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health-Related Quality of Life
Time frame: one year
The Stroke-Specific Quality of Life (SS-QOL) scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audny Anke, PhD study chair
Division of Rehabilitation Services, University Hospital of North
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Quality of Life, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related Quality of Life (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2019.