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Completed

NCT Number: NCT03672552

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FFWP and Improved Oral Care

Other

The FFWP with dental hygiene participants will have assessments for swallowing and oral health then proceed to have a dental hygienist cleaning. This intervention group will have supervised and assisted tooth brushing by nursing staff before taking plain (thin) unmodified water and between meals.

Other names: Dental hygienist intervention and supervised tooth brushing

Primary outcomes

  1. 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

  1. Incidence of positive experience with FFWP intervention.

    Time frame: 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.

  2. Change in Hydration

    Time frame: 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.

  3. Change in Nutrition.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Memorial University of Newfoundland

Other

Collaborators

  • Eastern Health
  • Newfoundland and Labrador Support for Patient-Oriented Research

Registry information

Official study title

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

Acronym: FFWP

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 14, 2018
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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