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

NCT ID: NCT03672552

Last Updated: 2020-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-19

Study Completion Date

2019-11-30

Brief Summary

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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

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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.

Conditions

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Dysphagia Respiratory Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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FFWP and Improved Oral Care

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

Group Type EXPERIMENTAL

FFWP and Improved Oral Care

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Dental hygienist intervention and supervised tooth brushing

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eastern Health

OTHER

Sponsor Role collaborator

Newfoundland and Labrador Support for Patient-Oriented Research

UNKNOWN

Sponsor Role collaborator

Memorial University of Newfoundland

OTHER

Sponsor Role lead

Responsible Party

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Roberta DiDonato

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roberta M DiDonato, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial University of Newfoundland

Locations

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Eastern Health-Pleasant View Towers

St. John's, Newfoundland and Labrador, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type RESULT
PMID: 27878598 (View on PubMed)

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.

Reference Type RESULT
PMID: 16945022 (View on PubMed)

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.

Reference Type RESULT
PMID: 19561160 (View on PubMed)

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.

Reference Type RESULT
PMID: 21185232 (View on PubMed)

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.

Reference Type RESULT
PMID: 26966356 (View on PubMed)

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.

Reference Type RESULT
PMID: 27621242 (View on PubMed)

Related Links

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http://research.library.mun.ca/id/eprint/11694

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

Other Identifiers

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2018.162

Identifier Type: -

Identifier Source: org_study_id

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