Quality of CareSPET-72NCT03259737
An Observational Study of Stroke Patients.
An observational study of Quality of Care and Cerebrovascular Disorders, run by Ellen Bøhmer at 2 sites in Norway.
Trial summary
The intention is to study presumed changes in daily practice, probably due to New Guidelines concerning stroke patients. The impression is more frequent measurements of blood pressure, serum glucose, troponin and supplementary computer tomography or magnetic resonance imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Care, Cerebrovascular Disorders, Hyperglycemia
- How many people
- 120 participants
- Where
- 2 sitesNorway
- Study dates
- 1 May 2018to 1 Dec 2022
- 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 > 18 years, registered with a diagnosis of stroke during 2015 at Innlandet Hospital Trust Lillehammer.
Who may be able to join
- Patients with a diagnosis of stroke according to ICD 10th revision (code I61 I63 and I64)
- Hospitalized between January 1 and December 31, 2015
Who cannot join
- Previous hospitalization with a diagnosis of stroke in 2015.
- Foreigners and patients from other regions of Norway.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Innlandet Hospital Trust Lillehammer
Lillehammer, 2609
Ellen Bøhmer
Lillehammer
About this study
Official title: An Observational Study of Stroke Patients With Focus on Examinations and Therapeutic Improvement the First 72 Hours.
The intention is to study presumed changes in daily practice, probably due to New Guidelines concerning stroke patients. The impression is more frequent measurements of blood pressure, serum glucose, troponin and supplementary computer tomography or magnetic resonance imaging.
Read the detailed description
There is in general a focus on misuse of health resources. An increasing amount of guidelines is produced to reduce the variation in treatment of patients with the same diagnosis. Many recommendations are weak but seems though to have considerable impact on in hospital care. The issues to be studied are all grounded on weak clinical evidence. A pilot study confirmed the suspicion of very frequent measurements of blood pressure, glucose, troponin and frequent supplementary CT and MRI. The intention is to study these issues in a larger population including an evaluation of utility of the different examinations and evaluations.
- Medical subject headings
- Cerebrovascular Disorders, Hyperglycemia, Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of supplementary computer tomography and magnetic resonance imaging of the brain.
Number
Measured: 3 months
The number of blood sugar measurements
Number
Measured: 72 hours after admission to hospital
Secondary outcomes (3)
Troponin measurement,
frequency and level of max value
Measured: 72 hours
Number of blood pressure measurement
Number
Measured: 72 hours
Transfer to tertiary center
Number
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start1 May 2018
- Primary completion15 Nov 2018
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of CareStudies 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
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ellen Bøhmer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ellen Bøhmer, Sykehuset Innlandet HF
- Investigators
- Ingebjørg Hartz, Study director, Sykehuset Innlandet HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259737
- Sponsor's protocol ID
- REK2015/358
- Acronym
- SPET-72
- Status last verified
- Dec 2020
- First submitted
- 21 Aug 2017
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Stroke Patients With Focus on Examinations and Therapeutic Improvement the First 72 Hours.
- ClinicalTrials.gov ID
- NCT03259737
- Acronym / sponsor ID
- SPET-72 / REK2015/358
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ellen BøhmerUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 24 Aug 2017 (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.
The intention is to study presumed changes in daily practice, probably due to New Guidelines concerning stroke patients. The impression is more frequent measurements of blood pressure, serum glucose, troponin and supplementary computer tomography or magnetic resonance imaging.
Detailed description
There is in general a focus on misuse of health resources. An increasing amount of guidelines is produced to reduce the variation in treatment of patients with the same diagnosis. Many recommendations are weak but seems though to have considerable impact on in hospital care. The issues to be studied are all grounded on weak clinical evidence. A pilot study confirmed the suspicion of very frequent measurements of blood pressure, glucose, troponin and frequent supplementary CT and MRI. The intention is to study these issues in a larger population including an evaluation of utility of the different examinations and evaluations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients > 18 years, registered with a diagnosis of stroke during 2015 at Innlandet Hospital Trust Lillehammer.
Key inclusion criteria (2 listed)
- Patients with a diagnosis of stroke according to ICD 10th revision (code I61 I63 and I64)
- Hospitalized between January 1 and December 31, 2015
Key exclusion criteria (2 listed)
- Previous hospitalization with a diagnosis of stroke in 2015.
- Foreigners and patients from other regions of Norway.
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
Number of supplementary computer tomography and magnetic resonance imaging of the brain.
Time frame: 3 months
Number
The number of blood sugar measurements
Time frame: 72 hours after admission to hospital
Number
3 secondary outcomes
Troponin measurement,
Time frame: 72 hours
Number of blood pressure measurement
Time frame: 72 hours
Transfer to tertiary center
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- 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.
Ingebjørg Hartz study director
Sykehuset Innlandet HF
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Care and Cerebrovascular Disorders, run by Ellen Bøhmer at 2 sites 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 2 inclusion and 2 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 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Number of supplementary computer tomography and magnetic resonance imaging of the brain. (time frame: 3 months). The study lists 2 primary outcomes in all. 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 5 Jan 2021.