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

This study has been completed.
Sponsor:
Collaborator:
B.C. Rehabilitation Foundation
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00616512
First received: February 4, 2008
Last updated: June 22, 2011
Last verified: June 2011
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of a Water Protocol for Clients With Thin Liquid Dysphagia: a Pilot Project

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Feasibility [ Time Frame: Information not available ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Fluid intake, client satisfaction, quality of life, adverse events [ Time Frame: Information not available ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: April 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616512

Locations
Canada, British Columbia
GF Strong Rehabilitation Centre
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
B.C. Rehabilitation Foundation
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
  More Information

No publications provided

Responsible Party: Caren Carlaw, University of British Columbia
ClinicalTrials.gov Identifier: NCT00616512     History of Changes
Other Study ID Numbers: H07-02582
Study First Received: February 4, 2008
Last Updated: June 22, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Water
oral care
oral hygiene
dysphagia
thin liquid dysphagia
thickened liquids

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014