A Randomized Controlled Trial of a Water Protocol for Clients With Thin Liquid Dysphagia

June 22, 2011 updated by: University of British Columbia

A Randomized Controlled Trial of a Water Protocol for Clients With Thin Liquid Dysphagia: a Pilot Project

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • British Columbia
      • Vancouver, British Columbia, Canada
        • GF Strong Rehabilitation Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: 1
GF Strong Water Protocol/ water allowed between meals after oral care for selected clients/ Fraser Water Protocol
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.

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

February 4, 2008

First Submitted That Met QC Criteria

February 4, 2008

First Posted (Estimate)

February 15, 2008

Study Record Updates

Last Update Posted (Estimate)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 22, 2011

Last Verified

June 1, 2011

More Information

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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