Stroke, AcuteNCT03948906
Stroke and Rehabilitation in North of Norway and Central Denmark
An observational study of Stroke, Acute, run by University Hospital of North Norway.
Trial summary
Post-stroke prospective multicenter cohort study. The objectives of the study was to compare functioning and health related quality of life in the two study regions, in relation to known predictors and to differences in organization of treatment- and rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- How many people
- 815 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Dec 2023
- 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: Adult patients with ischemic or hemorrhagic stroke
Who may be able to join
- Hospitalised in Stroke Units
- Living in a defined geographic area in North of Norway or in Central Denmark
Who cannot join
None listed.
About this study
Official title: Comparing Post-stroke Functioning and Rehabilitation Pathways in a Region of North of Norway and a Region of Denmark. A Prospective Cohort Study.
Post-stroke prospective multicenter cohort study. The objectives of the study was to compare functioning and health related quality of life in the two study regions, in relation to known predictors and to differences in organization of treatment- and rehabilitation. The inclusion was of consecutive acute stroke patients with ICD10 diagnosis I.63 and I.61 from a regional part of Northern Norway and Jylland Denmark. All were referred to stroke units. At baseline national stroke registry data were collected in each country. A questionnaire package was mailed to the participants 3- and 12-months post stroke. Telephone interviews at 3 months post stroke added information on functioning and rehabilitation.
Read the detailed description
Post-stroke prospective multicenter cohort study. The objectives of the study was to compare functioning and health related quality of life in the two study regions, in relation to known predictors and to differences in organization of treatment- and rehabilitation. The inclusion was of consecutive acute stroke patients with ICD10 diagnosis I.63 and I.61 from a regional part of Northern Norway and Jylland Denmark. All were referred to stroke units. At baseline national stroke registry data were collected in each country. Telephone interviews at 3 months post stroke added information on functioning and rehabilitation. A questionnaire package was mailed to the participants 3- and 12-months post stroke. These included validated Questionnaires like QOLIBRI-OS, HADS, SS-QOL and EQ5D.
Validity studies on QOLIBRI-OS and SS-QOL has been published, along with several other papers. Synne Garder Pedersen and Guri Heiberg have finished their PhDs.
- Conditions
- Stroke, Acute
- Keywords
- Stroke, Observational study, Rehabilitation, Health related quality of life
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
HRQOL
HRQOL measured by QOLIBRI-OS
Measured: 2014- 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study startApr 2014
- Primary completionJul 2020
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies 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
- 815 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Regionshospitalet Hammel Neurocenter
- Responsible party
- Principal investigator, Audny Anke, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948906
- Sponsor's protocol ID
- SF 1175-14NCT02311426
- Status last verified
- Oct 2022
- First submitted
- 10 May 2019
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pedersen SG, Heiberg GA, Nielsen JF, Friborg O, Stabel HH, Anke A, Arntzen C. Validity, reliability and Norwegian adaptation of the Stroke-Specific Quality of Life (SS-QOL) scale. SAGE Open Med. 2018 Jan 8;6:2050312117752031. doi: 10.1177/2050312117752031. eCollection 2018.
PubMed 29344360Heiberg G, Pedersen SG, Friborg O, Nielsen JF, Holm HS, Steinbuchel von N, Arntzen C, Anke A. Can the health related quality of life measure QOLIBRI- overall scale (OS) be of use after stroke? A validation study. BMC Neurol. 2018 Jul 18;18(1):98. doi: 10.1186/s12883-018-1101-9.
PubMed 30021558
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Post-stroke Functioning and Rehabilitation Pathways in a Region of North of Norway and a Region of Denmark. A Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT03948906
- Acronym / sponsor ID
- SF 1175-14NCT02311426
- Conditions
- Stroke, Acute
- Keywords
- Stroke, Observational study, Rehabilitation, Health related quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 815 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Regionshospitalet Hammel Neurocenter
- Study start
- Apr 2014 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 14 May 2019 (actual)
- 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.
Post-stroke prospective multicenter cohort study. The objectives of the study was to compare functioning and health related quality of life in the two study regions, in relation to known predictors and to differences in organization of treatment- and rehabilitation. The inclusion was of consecutive acute stroke patients with ICD10 diagnosis I.63 and I.61 from a regional part of Northern Norway and Jylland Denmark. All were referred to stroke units. At baseline national stroke registry data were collected in each country. A questionnaire package was mailed to the participants 3- and 12-months post stroke. Telephone interviews at 3 months post stroke added information on functioning and rehabilitation.
Detailed description
Post-stroke prospective multicenter cohort study. The objectives of the study was to compare functioning and health related quality of life in the two study regions, in relation to known predictors and to differences in organization of treatment- and rehabilitation. The inclusion was of consecutive acute stroke patients with ICD10 diagnosis I.63 and I.61 from a regional part of Northern Norway and Jylland Denmark. All were referred to stroke units. At baseline national stroke registry data were collected in each country. Telephone interviews at 3 months post stroke added information on functioning and rehabilitation. A questionnaire package was mailed to the participants 3- and 12-months post stroke. These included validated Questionnaires like QOLIBRI-OS, HADS, SS-QOL and EQ5D.
Validity studies on QOLIBRI-OS and SS-QOL has been published, along with several other papers. Synne Garder Pedersen and Guri Heiberg have finished their PhDs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with ischemic or hemorrhagic stroke
Key inclusion criteria (2 listed)
- Hospitalised in Stroke Units
- Living in a defined geographic area in North of Norway or in Central Denmark
Key exclusion criteria (0 listed)
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
HRQOL
Time frame: 2014- 2016
HRQOL measured by QOLIBRI-OS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Background: PubMed 29344360Pedersen SG, Heiberg GA, Nielsen JF, Friborg O, Stabel HH, Anke A, Arntzen C. Validity, reliability and Norwegian adaptation of the Stroke-Specific Quality of Life (SS-QOL) scale. SAGE Open Med. 2018 Jan 8;6:2050312117752031. doi: 10.1177/2050312117752031. eCollection 2018.
- Results publication: PubMed 30021558Heiberg G, Pedersen SG, Friborg O, Nielsen JF, Holm HS, Steinbuchel von N, Arntzen C, Anke A. Can the health related quality of life measure QOLIBRI- overall scale (OS) be of use after stroke? A validation study. BMC Neurol. 2018 Jul 18;18(1):98. doi: 10.1186/s12883-018-1101-9.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute, run by University Hospital of North 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 2 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
HRQOL (time frame: 2014- 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03948906, which also lists 2 linked publications.
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 13 Oct 2022.