Patient Experiences on the Stroke Unit | NCT05734352

Studies
Patient Experiences on the Stroke Unit

NCT05734352

Sponsor

KU Leuven

Status

Unknown status

Last Update Posted

Feb 7, 2024Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Ischemic Stroke

Interventions

Questionnaire

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 21, 2023Actual

Primary Completion Date

Sep 30, 2024Estimated

Completion Date

Sep 30, 2024Estimated

First Submitted Date

Feb 8, 2023

First Submission Date that Met QC Criteria

Feb 16, 2023

First Posted Date

Feb 17, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2024

Last Update Posted Date

Feb 7, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention		Completion of questionnaire	Other: Questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	Completion of the patient reported experience measurements (PREMs) questionnaire	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Patient experiences	How do patients experience their received care when they are admitted to the stroke unit/neurology department	6-months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with ischemic stroke

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
KU Leuven		Leuven	Flemish Brabant	3000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided