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

Primary Purpose

Dysphagia, Respiratory Tract Infections

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
FFWP and Improved Oral Care
Sponsored by
Memorial University of Newfoundland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dysphagia focused on measuring Aspiration pneumonia, Dementia, Dysphagia, Oral hygiene, Long-term care, Frazier Free Water

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eastern Health-Pleasant View Towers

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

FFWP and Improved Oral Care

Standard Care

Arm Description

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

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 Outcome Measures

Incidence of Chest Infections
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

Incidence of positive experience with FFWP intervention.
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 Hydration
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 in Nutrition.
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.

Full Information

First Posted
September 8, 2018
Last Updated
February 29, 2020
Sponsor
Memorial University of Newfoundland
Collaborators
Eastern Health, Newfoundland and Labrador Support for Patient-Oriented Research
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1. Study Identification

Unique Protocol Identification Number
NCT03672552
Brief Title
Using Plain Water With Oral Care to Increase Hydration for Long Term Care Residents With Disordered Swallowing
Acronym
FFWP
Official Title
Implementing the Frazier Free Water Protocol to Improve Hydration and Quality of Life in Long Term Care Residents
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 19, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Memorial University of Newfoundland
Collaborators
Eastern Health, Newfoundland and Labrador Support for Patient-Oriented Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Respiratory Tract Infections
Keywords
Aspiration pneumonia, Dementia, Dysphagia, Oral hygiene, Long-term care, Frazier Free Water

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All study participants will have assessments for swallowing and oral hygiene. The intervention group will have a dental hygiene cleaning and supervised tooth brushing before taking plain, thin (unmodified) water and between meals. The control group will continue with standard oral care and the agreed upon diet texture and fluid modifications.
Masking
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.
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FFWP and Improved Oral Care
Arm Type
Experimental
Arm Description
Receiving dental hygienist cleaning with supervised tooth brushing and FFWP (plain, unmodified water).
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
FFWP and Improved Oral Care
Other Intervention Name(s)
Dental hygienist intervention and supervised tooth brushing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Chest Infections
Description
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.
Time Frame
Change from baseline (Day-0 to 90 days)
Secondary Outcome Measure Information:
Title
Incidence of positive experience with FFWP intervention.
Description
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.
Time Frame
Change from baseline (Day 0-90 days)
Title
Change in Hydration
Description
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.
Time Frame
Change from baseline (Day-0 to 90 days)
Title
Change in Nutrition.
Description
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.
Time Frame
Change from baseline (Day 0 to 180 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberta M DiDonato, PhD
Organizational Affiliation
Memorial University of Newfoundland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastern Health-Pleasant View Towers
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 0L7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
27878598
Citation
Gillman A, Winkler R, Taylor NF. Implementing the Free Water Protocol does not Result in Aspiration Pneumonia in Carefully Selected Patients with Dysphagia: A Systematic Review. Dysphagia. 2017 Jun;32(3):345-361. doi: 10.1007/s00455-016-9761-3. Epub 2016 Nov 23.
Results Reference
result
PubMed Identifier
16945022
Citation
Azarpazhooh A, Leake JL. Systematic review of the association between respiratory diseases and oral health. J Periodontol. 2006 Sep;77(9):1465-82. doi: 10.1902/jop.2006.060010.
Results Reference
result
PubMed Identifier
19561160
Citation
Cabre M, Serra-Prat M, Palomera E, Almirall J, Pallares R, Clave P. Prevalence and prognostic implications of dysphagia in elderly patients with pneumonia. Age Ageing. 2010 Jan;39(1):39-45. doi: 10.1093/ageing/afp100. Epub 2009 Jun 26.
Results Reference
result
PubMed Identifier
21185232
Citation
Forsell M, Kullberg E, Hoogstraate J, Johansson O, Sjogren P. An evidence-based oral hygiene education program for nursing staff. Nurse Educ Pract. 2011 Jul;11(4):256-9. doi: 10.1016/j.nepr.2010.11.017. Epub 2010 Dec 23.
Results Reference
result
PubMed Identifier
26966356
Citation
Wirth R, Dziewas R, Beck AM, Clave P, Hamdy S, Heppner HJ, Langmore S, Leischker AH, Martino R, Pluschinski P, Rosler A, Shaker R, Warnecke T, Sieber CC, Volkert D. Oropharyngeal dysphagia in older persons - from pathophysiology to adequate intervention: a review and summary of an international expert meeting. Clin Interv Aging. 2016 Feb 23;11:189-208. doi: 10.2147/CIA.S97481. eCollection 2016.
Results Reference
result
PubMed Identifier
27621242
Citation
Agarwal E, Marshall S, Miller M, Isenring E. Optimising nutrition in residential aged care: A narrative review. Maturitas. 2016 Oct;92:70-78. doi: 10.1016/j.maturitas.2016.06.013. Epub 2016 Jun 23.
Results Reference
result
Links:
URL
http://research.library.mun.ca/id/eprint/11694
Description
The Prevalence of Dysphagia in Long-Term Care Facility [Thesis]; Memorial University, St. John's , NL
URL
http://secure.cihi.ca/free_products/ED_Report_ForWeb_EN_Final.pdf
Description
Sources of Potentially Avoidable Emergency Department Visits. Ottawa: Canadian Institute of Health Information: Health System Performance

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

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