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

Dysphagia Clinical Trial

— FFWP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03672552
• Other study ID #: 2018.162
• Status: Completed
• Phase: N/A
• Start date: June 19, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: February 2020
• Source: Memorial University of Newfoundland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Respiratory Tract Infections

Intervention

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.

Locations

Country	Name	City	State
Canada	Eastern Health-Pleasant View Towers	Saint John's	Newfoundland and Labrador

Sponsors (3)

Lead Sponsor	Collaborator
Memorial University of Newfoundland	Eastern Health, Newfoundland and Labrador Support for Patient-Oriented Research

Country where clinical trial is conducted

Canada, 

References & Publications (6)

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. Review. — View Citation

Azarpazhooh A, Leake JL. Systematic review of the association between respiratory diseases and oral health. J Periodontol. 2006 Sep;77(9):1465-82. Review. — View Citation

Cabre M, Serra-Prat M, Palomera E, Almirall J, Pallares R, Clavé 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. — View Citation

Forsell M, Kullberg E, Hoogstraate J, Johansson O, Sjögren 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. — View 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 — View Citation

Wirth R, Dziewas R, Beck AM, Clavé P, Hamdy S, Heppner HJ, Langmore S, Leischker AH, Martino R, Pluschinski P, Rösler A, Shaker R, Warnecke T, Sieber CC, Volkert D. Oropharyngeal dysphagia in older persons - from pathophysiology to adequate intervention: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 from baseline (Day 0-90 days)
Secondary	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 from baseline (Day-0 to 90 days)
Secondary	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.	Change from baseline (Day 0 to 180 days)

External Links

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