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

February 29, 2020 updated by: Roberta DiDonato, Memorial University of Newfoundland

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Newfoundland and Labrador
      • Saint John's, Newfoundland and Labrador, Canada, A1A 0L7
        • Eastern Health-Pleasant View Towers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FFWP and Improved Oral Care
Receiving dental hygienist cleaning with supervised tooth brushing and FFWP (plain, unmodified water).
Other: FFWP and Improved Oral Care
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
No Intervention: Standard Care
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change from baseline (Day-0 to 90 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Change from baseline (Day 0-90 days)
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.
Change from baseline (Day-0 to 90 days)
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.
Change from baseline (Day 0 to 180 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial University of Newfoundland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eastern Health
Newfoundland and Labrador Support for Patient-Oriented Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Roberta M DiDonato, PhD, Memorial University of Newfoundland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 19, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018.162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data sharing guarded by privacy legislation and will require special application. Some documentation or research materials without participant data or identification may be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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