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

NCT03672552 | Completed

• 1 other identifier: 2018.162
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia; Respiratory Tract Infections

Keywords

Aspiration pneumonia; Dementia; Dysphagia; Oral hygiene; Long-term care; Frazier Free Water

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline (Day-0 to 90 days)

Secondary Outcomes (3)

• Incidence of positive experience with FFWP intervention.

  Change from baseline (Day 0-90 days)

• Change in Hydration

  Change from baseline (Day-0 to 90 days)

• Change in Nutrition.

  Change from baseline (Day 0 to 180 days)

Study Arms (2)

FFWP and Improved Oral Care

EXPERIMENTAL

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

Other: FFWP and Improved Oral Care

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.

Interventions

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.

Also known as: Dental hygienist intervention and supervised tooth brushing

FFWP and Improved Oral Care

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial University of Newfoundland: lead
• Eastern Health: collaborator
• Newfoundland and Labrador Support for Patient-Oriented Research: collaborator

Study Sites (1)

Eastern Health-Pleasant View Towers

St. John's, Newfoundland and Labrador, A1A 0L7, Canada

Location

Related Publications (6)

• 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.

  PMID: 27878598 RESULT

• 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.

  PMID: 16945022 RESULT

• 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.

  PMID: 19561160 RESULT

• 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.

  PMID: 21185232 RESULT

• 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.

  PMID: 26966356 RESULT

• 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.

  PMID: 27621242 RESULT

Related Links

• The Prevalence of Dysphagia in Long-Term Care Facility \[Thesis\]; Memorial University, St. John's , NL

MeSH Terms

Conditions

Deglutition Disorders; Respiratory Tract Infections; Pneumonia, Aspiration; Dementia

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Roberta M DiDonato, PhD

  Memorial University of Newfoundland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor, Faculty of Science and Medicine, Research Director Anesthesiology

Model Details: 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.

Study Record Dates

• First Submitted: September 8, 2018
• First Posted: September 14, 2018
• Study Start: June 19, 2019
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: March 3, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)