- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00616512
A Randomized Controlled Trial of a Water Protocol for Clients With Thin Liquid Dysphagia
A Randomized Controlled Trial of a Water Protocol for Clients With Thin Liquid Dysphagia: a Pilot Project
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada
- GF Strong Rehabilitation Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Potential participants in this study will include all clients aged 19 years and older who are admitted to GF Strong Acquired Brain Injury (ABI) and Neruomusculoskeletal (NMS) and Adolescent and Young Adult (AYA) programs and who have thin liquid dysphagia resulting from a neurological diagnosis. The thin liquid dysphagia will be confirmed by a Modified Barium Swallow conducted by a certified speech-language pathologist. Potential participants must be proficient in English in order to complete the questionnaires and capable of understanding the consent form.
Exclusion Criteria:
Clients who present with the following will be excluded: active pneumonia, acute or unstable medical condition, surgery where coughing might rip stitches or cause pain or discomfort, oral dental bacteria or infection that cannot be controlled, poor oral hygiene that cannot be improved with routine care, excessive or uncomfortable coughing during or after intake, severe or uncontrolled GERD, immunosuppressed, or decline participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
GF Strong Water Protocol/ water allowed between meals after oral care for selected clients/ Fraser Water Protocol
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The Purpose of the GF Strong water protocol is to allow clients who have thin liquid dysphagia to drink water under certain specified conditions according to the rules of the water protocol.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Feasibility
Time Frame: Information not available
|
Information not available
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fluid intake, client satisfaction, quality of life, adverse events
Time Frame: Information not available
|
Information not available
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Caren Carlaw, MA, University of British Columbia
- Study Director: Heather Finlayson, MD, FRCPC, University of British Columbia
- Study Director: Kathleen Beggs, Bse RDN, University of British Columbia
- Study Director: Andrew Travlos, MBBCh FRCPC, University of British Columbia
- Study Director: Dawn Coney, RN (CRN), University of British Columbia
- Study Director: Tiffany Visser, MS, University of British Columbia
- Study Director: Caroline Marcoux, MS, University of British Columbia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H07-02582
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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