Clinical trial NCT03672552: Using Plain Water With Oral Care to Increase Hydration for Long Term Care Residents With Disordered Swallowing
Official title: Implementing the Frazier Free Water Protocol to Improve Hydration and Quality of Life in Long Term Care Residents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Respiratory Tract Infections
Keywords: Aspiration pneumonia
Dementia
Dysphagia
Oral hygiene
Long-term care
Frazier Free Water
Lead sponsor: Memorial University of Newfoundland
Sponsor class: OTHER
Collaborators: name: Eastern Health
name: Newfoundland and Labrador Support for Patient-Oriented Research
First posted: 2018-09-14
Enrollment: 27
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Incidence of Chest Infections
timeFrame: Change from baseline (Day-0 to 90 days)
Secondary outcomes:
measure: Incidence of positive experience with FFWP intervention.
timeFrame: Change from baseline (Day 0-90 days)
measure: Change in Hydration
timeFrame: Change from baseline (Day-0 to 90 days)
measure: Change in Nutrition.
timeFrame: Change from baseline (Day 0 to 180 days)
Other outcomes:
Locations:
city: Saint John's
country: Canada
facility: Eastern Health-Pleasant View Towers
state: Newfoundland and Labrador
Study officials:
affiliation: Memorial University of Newfoundland
name: Roberta M DiDonato, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.