Ischemic StrokeBIC4CVAPREMSNCT05734352
Patient Experiences on the Stroke Unit
An observational study of Ischemic Stroke, run by KU Leuven at 1 site in Belgium.
Trial summary
In this study we want to develop and validate a PREM for patient with ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Questionnaire
- How many people
- 500 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Feb 2023to 30 Sep 2024
- 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
- Adult, Older adult
Study population: Patients with ischemic stroke
Who may be able to join
- > 18 years
- ischemic stroke
- stayed at least one day at the stroke unit
Who cannot join
- not able to read the questionnaire
- not able to answer question orally
- are not proficient in the dutch language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Experiences of the CVA Care Program on the Stroke Unit
In this study we want to develop and validate a PREM for patient with ischemic stroke.
Read the detailed description
Patient Reported Experience Measures (PREMs) assess patient's perception of health care. Currently, there is no suitable PREM tool for patients with ischemic stroke. Therefore, we aim to develop and validate a PREM for this patient population. This PREM will be validated in a multicentre study, in 10 Flemish hospitals. We want to investigate the feasibility of our new questionnaire, as well as the usefulness. In addition we well analyse the results of the questionnaires and use this information to improve the quality of the care program for stroke patients.
- Conditions
- Ischemic Stroke
- Being tested
- Questionnaire
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Completion of the patient reported experience measurements (PREMs) questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Completion of questionnaire Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of a new Patient Reported Experience Measurements (PREMs) for stroke patients
Validation of a questionnaire which was developed based on literature and consensus meeting
Measured: 6-months
Secondary outcomes (1)
Patient experiences
How do patients experience their received care when they are admitted to the stroke unit/neurology department
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start21 Feb 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kris Vanhaecht, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734352
- Sponsor's protocol ID
- BIC4STROKEPREMS
- Acronym
- BIC4CVAPREMS
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2023
- Last updated
- 7 Feb 2024
- 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 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Experiences of the CVA Care Program on the Stroke Unit
- ClinicalTrials.gov ID
- NCT05734352
- Acronym / sponsor ID
- BIC4CVAPREMS / BIC4STROKEPREMS
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 17 Feb 2023 (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.
In this study we want to develop and validate a PREM for patient with ischemic stroke.
Detailed description
Patient Reported Experience Measures (PREMs) assess patient's perception of health care. Currently, there is no suitable PREM tool for patients with ischemic stroke. Therefore, we aim to develop and validate a PREM for this patient population. This PREM will be validated in a multicentre study, in 10 Flemish hospitals. We want to investigate the feasibility of our new questionnaire, as well as the usefulness. In addition we well analyse the results of the questionnaires and use this information to improve the quality of the care program for stroke patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Other: QuestionnaireCompletion of questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with ischemic stroke
Key inclusion criteria (3 listed)
- > 18 years
- ischemic stroke
- stayed at least one day at the stroke unit
Key exclusion criteria (3 listed)
- not able to read the questionnaire
- not able to answer question orally
- are not proficient in the dutch language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireCompletion of the patient reported experience measurements (PREMs) questionnaire | Other | Intervention |
Primary outcome
Validation of a new Patient Reported Experience Measurements (PREMs) for stroke patients
Time frame: 6-months
Validation of a questionnaire which was developed based on literature and consensus meeting
1 secondary outcome
Patient experiences
Time frame: 6-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- 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.
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 Ischemic Stroke, run by KU Leuven at 1 site in Belgium.
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 3 inclusion and 3 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 7 Feb 2024. 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 Belgium. 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?
Validation of a new Patient Reported Experience Measurements (PREMs) for stroke patients (time frame: 6-months). 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 7 Feb 2024.