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Clinical Trials/NCT03672552
NCT03672552CompletedNot Applicable

Implementing the Frazier Free Water Protocol to Improve Hydration and Quality of Life in Long Term Care Residents

Memorial University of Newfoundland1 site in 1 country27 target enrollmentStarted: June 19, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
27
Locations
1
Primary Endpoint
Incidence of Chest Infections

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Masking Description

Participants may identify with the study receiving more oral care than previously but not know if they are in the intervention or control group. Clinicians performing swallowing and oral health assessments will not know which participants are randomly assigned to groups. Nursing staff will be performing daily care on all participants as specified in daily nursing protocols and may have more oral care but may not identify whether a participant is in the intervention or control group except some staff will be adding supervised brushing before plain (thin) water and between mealtimes.

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

FFWP and Improved Oral Care

Experimental

Receiving dental hygienist cleaning with supervised tooth brushing and FFWP (plain, unmodified water).

Intervention: FFWP and Improved Oral Care (Other)

Standard Care

No Intervention

This group has assessments and standard oral care with no dental hygienist cleaning, no FFWP or supervised tooth brushing and continuing with agreed upon diet texture and fluid modification.

Outcomes

Primary Outcomes

Incidence of Chest Infections

Time Frame: 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 Outcomes

  • Incidence of positive experience with FFWP intervention.(Change from baseline (Day 0-90 days))
  • Change in Nutrition.(Change from baseline (Day 0 to 180 days))
  • Change in Hydration(Change from baseline (Day-0 to 90 days))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Roberta DiDonato

Adjunct Professor, Faculty of Science and Medicine, Research Director Anesthesiology

Memorial University of Newfoundland

Study Sites (1)

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