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

NCT ID: NCT00616512

Last Updated: 2011-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-06-30

Brief Summary

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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. 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

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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.

Conditions

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Thin Liquid Dysphagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

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

Group Type EXPERIMENTAL

GF Strong Water Protocol

Intervention Type PROCEDURE

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.

Interventions

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GF Strong 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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B.C. Rehabilitation Foundation

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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University of British Columbia

Principal Investigators

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Caren Carlaw, MA

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Heather Finlayson, MD, FRCPC

Role: STUDY_DIRECTOR

University of British Columbia

Kathleen Beggs, Bse RDN

Role: STUDY_DIRECTOR

University of British Columbia

Andrew Travlos, MBBCh FRCPC

Role: STUDY_DIRECTOR

University of British Columbia

Dawn Coney, RN (CRN)

Role: STUDY_DIRECTOR

University of British Columbia

Tiffany Visser, MS

Role: STUDY_DIRECTOR

University of British Columbia

Caroline Marcoux, MS

Role: STUDY_DIRECTOR

University of British Columbia

Locations

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GF Strong Rehabilitation Centre

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H07-02582

Identifier Type: -

Identifier Source: org_study_id

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