Back to resultsA Randomized Controlled Trial of a Water Protocol for Clients With Thin Liquid Dysphagia
Primary Purpose
Thin Liquid Dysphagia
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
GF Strong Water Protocol
Sponsored by
About this trial
This is an interventional treatment trial for Thin Liquid Dysphagia focused on measuring Water, oral care, oral hygiene, dysphagia, thin liquid dysphagia, thickened liquids
Eligibility Criteria
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.
Sites / Locations
- GF Strong Rehabilitation Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
GF Strong Water Protocol/ water allowed between meals after oral care for selected clients/ Fraser Water Protocol
Outcomes
Primary Outcome Measures
Feasibility
Secondary Outcome Measures
Fluid intake, client satisfaction, quality of life, adverse events
Full Information
NCT ID
NCT00616512
First Posted
February 4, 2008
Last Updated
June 22, 2011
Sponsor
University of British Columbia
Collaborators
B.C. Rehabilitation Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00616512
Brief Title
A Randomized Controlled Trial of a Water Protocol for Clients With Thin Liquid Dysphagia
Official Title
A Randomized Controlled Trial of a Water Protocol for Clients With Thin Liquid Dysphagia: a Pilot Project
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of British Columbia
Collaborators
B.C. Rehabilitation Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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. Water Protocols have been shown to improve client satisfaction, and hydration. We wish to assess this in a randomized, controlled fashion, and this is a pilot project to determine feasibility.
Detailed Description
GF Strong water protocol will be used with the study subjects. Control subjects will not receive water protocol. Pre and post measures will include SWAL-QOL, client satisfaction, water and thickened fluid intake, and monitoring for adverse events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thin Liquid Dysphagia
Keywords
Water, oral care, oral hygiene, dysphagia, thin liquid dysphagia, thickened liquids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
GF Strong Water Protocol/ water allowed between meals after oral care for selected clients/ Fraser Water Protocol
Intervention Type
Procedure
Intervention Name(s)
GF Strong Water Protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility
Time Frame
Information not available
Secondary Outcome Measure Information:
Title
Fluid intake, client satisfaction, quality of life, adverse events
Time Frame
Information not available
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caren Carlaw, MA
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heather Finlayson, MD, FRCPC
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kathleen Beggs, Bse RDN
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Andrew Travlos, MBBCh FRCPC
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dawn Coney, RN (CRN)
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tiffany Visser, MS
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Caroline Marcoux, MS
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
Facility Information:
Facility Name
GF Strong Rehabilitation Centre
City
Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Randomized Controlled Trial of a Water Protocol for Clients With Thin Liquid Dysphagia
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