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临床试验/NCT03672552
NCT03672552已完成不适用

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

Memorial University of Newfoundland1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2019年6月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
1
主要终点
Incidence of Chest Infections

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

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.

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

FFWP and Improved Oral Care

Experimental

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

干预措施: FFWP and Improved Oral Care (Other)

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.

结局指标

主要结局

Incidence of Chest Infections

时间窗: Change from baseline (Day-0 to 90 days)

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.

次要结局

  • Incidence of positive experience with FFWP intervention.(Change from baseline (Day 0-90 days))
  • Change in Nutrition.(Change from baseline (Day 0 to 180 days))
  • Change in Hydration(Change from baseline (Day-0 to 90 days))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Roberta DiDonato

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

Memorial University of Newfoundland

研究点 (1)

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