Using Plain Water With Oral Care to Increase Hydration for Long Term Care Residents With Disordered Swallowing

Not Applicable

Completed

• Conditions: Respiratory Tract Infections; Dysphagia
• Interventions: Other: FFWP and Improved Oral Care

• Registration Number: NCT03672552
• Lead Sponsor: Memorial University of Newfoundland

Brief Summary

The Frazier Free Water Protocol (FFWP) using plain, thin (unmodified) water is an accepted method to increase fluid intake and hydration in older adults with disordered swallowing and dementia.This study aims to take an interdisciplinary approach to see if the FFWP with improved oral care can be introduced in a long term care (LTC) setting comparing an intervention group with a control group receiving standard oral care, to prevent respiratory infections.

Detailed Description

The investigators will recruit a convenience sample of 36 participants from a single long-term care facility. Participants will be randomly assigned into control or intervention groups. Both groups will be assessed at study onset for swallowing and oral health and continue with agreed upon diet texture and fluid modifications. The intervention group (FFWP and improved oral hygiene) will receive a dental hygienist cleaning at onset of the study and have supervised tooth brushing before thin water between meals. The control group will continue with standard oral care and offered the full dental hygienist cleaning at the end of the study. If findings indicate no difference between groups on outcome measures (eg. respiratory illness, hydration, nutrition) then the intervention is considered efficacious in long-term care residents. If improvements in outcome measures are evident for the treatment relative to the control group, then this intervention may provide opportunity for improved healthcare and cost-savings.

Study Timeline

• Study First Submitted: 2018-09-08
• Study First Submitted QC: 2018-09-13
• Study First Posted: 2018-09-14
• Study Start: 2019-06-19
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-29
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Long Term Care Residents with moderate to severe swallowing difficulty and modified texture diet; or have a dry mouth and thirsty most of the time by report of patient participant, family or staff.

Exclusion Criteria

• Participant Resident taking part in another study; participant finished another study in last 30 days prior to this study; Participant has dental pain or waiting to see a dentist for pain and discomfort; Participant has current chest infection including pneumonia or is prone to chest infections with more than one episode per year; Participant is unable to tolerate assessments and oral care.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FFWP and Improved Oral Care	FFWP and Improved Oral Care	Receiving dental hygienist cleaning with supervised tooth brushing and FFWP (plain, unmodified water).

Primary Outcome Measures

Name	Time	Method
Incidence of Chest Infections	Change from baseline (Day-0 to 90 days)	To determine whether the Frazier Free Water Protocol (FFWP) with improved oral care will decrease risk of respiratory illness events (eg. chest congestion, fever, etc.) for long term care residents by numbers of documented cases of upper and lower respiratory illnesses and hospital admissions over a 90-day duration.

Secondary Outcome Measures

Name	Time	Method
Incidence of positive experience with FFWP intervention.	Change from baseline (Day 0-90 days)	Analysis of participant experience with FFWP intervention over the 90-day study period by scaled responses to feedback question: Did you feel this was a positive experience? Responses range from Strongly Agree, Agree, Disagree, Strongly Disagree and Neither Agree or Disagree.
Change in Nutrition.	Change from baseline (Day 0 to 180 days)	To assess change in nutrition associated with FFWP intervention measured by lab values for albumin, BUN (Blood, Urea, Nitrogen) and Creatinine obtained over the 90-day study period.
Change in Hydration	Change from baseline (Day-0 to 90 days)	To assess change in hydration associated with FFWP intervention measured by lab values for electrolytes, BUN (Blood, Urea, Nitrogen) and Creatinine obtained over the 90-day study period.

Trial Locations

Locations (1)

Eastern Health-Pleasant View Towers; 🇨🇦 Saint John's, Newfoundland and Labrador, Canada