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| Sponsors and Collaborators: |
University of British Columbia B.C. Rehabilitation Foundation |
|---|---|
| Information provided by: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00616512 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Thin Liquid Dysphagia |
Procedure: GF Strong Water Protocol |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Historical Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized Controlled Trial of a Water Protocol for Clients With Thin Liquid Dysphagia: a Pilot Project |
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
GF Strong Water Protocol/ water allowed between meals after oral care for selected clients/ Fraser Water Protocol
|
Procedure: 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.
|
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.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Caren Carlaw, MA | 604-737-6214 |
| Canada, British Columbia | |
| GF Strong Rehabilitation Centre | Recruiting |
| Vancouver, British Columbia, Canada | |
| Contact: Caren Carlaw, MA 604-737-6214 caren.carlaw@vch.ca | |
| 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 |
More Information
| Responsible Party: | University of British Columbia ( Caren Carlaw ) |
| Study ID Numbers: | H07-02582 |
| Study First Received: | February 4, 2008 |
| Last Updated: | August 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00616512 |
| Health Authority: | Canada: Health Canada |
|
Water oral care oral hygiene |
dysphagia thin liquid dysphagia thickened liquids |
|
Deglutition Disorders Otorhinolaryngologic Diseases Digestive System Diseases Esophageal disorder |
Gastrointestinal Diseases Esophageal Diseases Pharyngeal Diseases |
