NCT03147755

Brief Summary

Oropharyngeal dysphagia (OD) is a common morbidity after stroke that disrupts swallowing physiology. The investigators aimed at evaluating the prevalence of oropharyngeal dysphagia (OD) after stroke and analysing the risk factors and associated complications.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
395

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Longer than P75 for all trials

Status
completed

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

Study Start

First participant enrolled

May 1, 2010

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 10, 2017

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

4.3 years

First QC Date

May 4, 2017

Last Update Submit

July 30, 2020

Conditions

Deglutition Disorders

Keywords

stroke

Outcome Measures

Primary Outcomes (1)

  • Mortality

    OD mortality rates has been assessed

    1 year

Study Arms (2)

Dysphagia

Patients with stroke associated dysphagia

Other: No intervention

No dysphagia

Patients without stroke associated dysphagia

Other: No intervention

Interventions

No interventionOTHER

No intervention

DysphagiaNo dysphagia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to hospital with clinical suspicion of stroke

You may qualify if:

  • Patients admitted to hospital with confirmed stroke diagnosis; signed informed consent

You may not qualify if:

  • previous diagnosis of OD; transient ischemic attack; and being transferred from another hospital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Deglutition DisordersStroke

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 4, 2017

First Posted

May 10, 2017

Study Start

May 1, 2010

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

July 31, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share