- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05734352
Patient Experiences on the Stroke Unit (BIC4CVAPREMS)
February 5, 2024 updated by: Kris Vanhaecht, KU Leuven
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Flemish Brabant
-
Leuven, Flemish Brabant, Belgium, 3000
- KU Leuven
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Patients with ischemic stroke
Description
Inclusion Criteria:
- > 18 years
- ischemic stroke
- stayed at least one day at the stroke unit
Exclusion Criteria:
- not able to read the questionnaire
- not able to answer question orally
- are not proficient in the dutch language
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Intervention
Completion of questionnaire
|
Completion of the patient reported experience measurements (PREMs) questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
6-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient experiences
Time Frame: 6-months
|
How do patients experience their received care when they are admitted to the stroke unit/neurology department
|
6-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 21, 2023
Primary Completion (Estimated)
September 30, 2024
Study Completion (Estimated)
September 30, 2024
Study Registration Dates
First Submitted
February 8, 2023
First Submitted That Met QC Criteria
February 16, 2023
First Posted (Actual)
February 17, 2023
Study Record Updates
Last Update Posted (Estimated)
February 7, 2024
Last Update Submitted That Met QC Criteria
February 5, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIC4STROKEPREMS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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