NCT05379699

Brief Summary

Stroke is a leading cause of death and disability globally. Dysphagia, swallowing difficulty, is common following stroke, affecting about 55% of all stroke patients. People with stroke and dysphagia are three times more likely to develop pneumonia compared to patients with no dysphagia. Stroke best practice guidelines recommend early identification of dysphagia by bedside testing (called screening) of all patients admitted to hospital with stroke. Our group was the first to develop a screening tool for stroke patients, the Toronto Bedside Swallowing Screening Test (TOR-BSST©). It uses a step-by-step process to identify patients with dysphagia risk. TOR-BSST© screeners are health professionals who have successfully completed a live 4-hr training provided by a Speech Language Pathologist (SLP). There is good evidence that this training increases the accuracy of screening. However, a 4-hr live session is not acceptable with limited healthcare resources. Our aim is to evaluate the accuracy of an innovative eLearning program to train TOR-BSST© screeners. If successful, this project will shorten training time, reduce hospital resource burden, and ensure a sustainable dysphagia screening program for people with stroke in all hospitals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

October 1, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
Last Updated

June 23, 2023

Status Verified

June 1, 2023

Enrollment Period

2.4 years

First QC Date

May 12, 2022

Last Update Submit

June 22, 2023

Conditions

Keywords

StrokeDysphagiaScreeningRandomized Controlled TrialeLearning

Outcome Measures

Primary Outcomes (1)

  • Online Test of Screener Accuracy (Module 4)

    An online test of screening accuracy completed following the live 1-on-1 observation

    30 minutes

Secondary Outcomes (1)

  • Online Assessment of Trained Screeners (Module 3)

    30 minutes

Study Arms (3)

1

ACTIVE COMPARATOR

Standard 4-hour live screener training with 1-on-1 live observation by a speech-language pathologist.

Other: Standard TOR-BSST© Training

2

EXPERIMENTAL

New eLearning training with 1-on-1 live observation by a speech-language pathologist.

Other: TOR-BSST© eLearning Training

3

EXPERIMENTAL

New eLearning training with 1-on-1 live observation by a competency mentor.

Other: TOR-BSST© eLearning Training

Interventions

An online self-directed training program for TOR-BSST© dysphagia screeners.

23

Standard 4-hour in-person TOR-BSST© screener training conducted by a Speech-Language Pathologist.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any healthcare professional who has had no formal training in dysphagia screening and currently manages patients diagnosed with stroke.

You may not qualify if:

  • Any healthcare professional who has had prior formal training in dysphagia screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

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 Officials

  • Rosemary Martino, PhD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

May 12, 2022

First Posted

May 18, 2022

Study Start

October 1, 2020

Primary Completion

February 15, 2023

Study Completion

February 15, 2023

Last Updated

June 23, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations