Clinical trial NCT00616512: A Randomized Controlled Trial of a Water Protocol for Clients With Thin Liquid Dysphagia
Official title: A Randomized Controlled Trial of a Water Protocol for Clients With Thin Liquid Dysphagia: a Pilot Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Thin Liquid Dysphagia
Keywords: Water
oral care
oral hygiene
dysphagia
thin liquid dysphagia
thickened liquids
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: B.C. Rehabilitation Foundation
First posted: 2008-02-15
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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 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.

Primary outcomes:
measure: Feasibility
timeFrame: Information not available
Secondary outcomes:
measure: Fluid intake, client satisfaction, quality of life, adverse events
timeFrame: Information not available
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: GF Strong Rehabilitation Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Caren Carlaw, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Heather Finlayson, MD, FRCPC
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Kathleen Beggs, Bse RDN
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Andrew Travlos, MBBCh FRCPC
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Dawn Coney, RN (CRN)
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Tiffany Visser, MS
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Caroline Marcoux, MS
role: STUDY_DIRECTOR
References: