NCT05734352

Brief Summary

In this study we want to develop and validate a PREM for patient with ischemic stroke.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

February 21, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

1.6 years

First QC Date

February 8, 2023

Last Update Submit

February 5, 2024

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • 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

    6-months

Secondary Outcomes (1)

  • Patient experiences

    6-months

Study Arms (1)

Intervention

Completion of questionnaire

Other: Questionnaire

Interventions

QuestionnaireOTHER

Completion of the patient reported experience measurements (PREMs) questionnaire

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with ischemic stroke

You may qualify if:

  • \> 18 years
  • ischemic stroke
  • stayed at least one day at the stroke unit

You may not qualify if:

  • not able to read the questionnaire
  • not able to answer question orally
  • are not proficient in the dutch language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KU Leuven

Leuven, Flemish Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 8, 2023

First Posted

February 17, 2023

Study Start

February 21, 2023

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

February 7, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)