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

University of British Columbia logo

University of British Columbia

Status and phase

Completed
Phase 1

Conditions

Thin Liquid Dysphagia

Treatments

Procedure: GF Strong Water Protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT00616512
H07-02582

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 1 patient group

1
Experimental group
Description:
GF Strong Water Protocol/ water allowed between meals after oral care for selected clients/ Fraser Water Protocol
Treatment:
Procedure: GF Strong Water Protocol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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