跳至主要内容
临床试验/NCT01780402
NCT01780402已完成不适用

Comparison of Hand Feeding Techniques for Persons With Dementia Living in the Nursing Home

Duke University22 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
22
主要终点
Change in frequency of aversive feeding behaviors

研究概览

简要总结

The purpose of this study is to test three hand feeding techniques that can be used to provide feeding assistance to persons with dementia - direct hand feeding, hand-over-hand feeding, and hand-under-hand feeding.

详细描述

Proposed Aim 1: To collect pilot data related to using three hand feeding techniques for feeding persons with dementia (PWD) in the nursing home (NH) setting: (1) direct hand feeding; (2) hand-over-hand feeding; and, (3) hand-under-hand feeding. Primary outcomes are impact on frequency of aversive feeding behaviors, meal intake, and time spent assisting with feeding.

Proposed Aim 2: Evaluate implementation of the hand feeding intervention for larger randomized study of feeding techniques.

Aim 2a: Conduct a process evaluation for method of recruiting, screening, and obtaining informed consent of legally authorized representatives (LARs)/ assent of PWD.

Aim 2b: Establish fidelity to treatment for all three hand feeding interventions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

入排标准

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

入选标准

  • Resident of nursing home 6 weeks prior to intervention delivery
  • 60+ years old
  • Have a legally authorized representative to provide informed consent
  • medical diagnosis of dementia
  • required extensive assistance to total dependence for feeding
  • Brief Interview for Mental Status (BIMS) score of 0-12

排除标准

  • Positive diagnosis of Human Immunodeficiency Virus (HIV), Parkinson's, and/or Traumatic Brain Injury
  • Any swallowing disorder
  • Presence of feeding tube that is sole source for meal delivery
  • Significant auditory or visual impairment

结局指标

主要结局

Change in frequency of aversive feeding behaviors

时间窗: Day 6

Changes in behaviors of person with dementia being assisted with 3 meals daily over 6 days

Changes in time spent providing feeding assistance

时间窗: Day 6

Changes in time spent providing feeding assistance to a person with dementia being assisted with 3 meals daily over 6 days

Changes in meal intake

时间窗: Day 6

Changes in meal intake for a person with dementia being assisted with 3 meals daily over 6 days

次要结局

  • Develop decision-making algorithm of adaptive approaches used by feeding assistant(6 days)
  • Functional ability and feeding behaviors exhibited by person with dementia(Day 6)
  • Characterize feeding assistant responses to functional ability and feeding behaviors(6 days)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (22)

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