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临床试验/NCT02649244
NCT02649244已完成1 期

The Family Caregiver Training Program for Caregivers of People With Dementia: A Randomized Control Trial

Nova Southeastern University0 个研究点目标入组 36 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
36
主要终点
Caregiver Change in Activities of Daily Living Knowledge

研究概览

简要总结

The purpose of this study is to examine the effectiveness of the Family Caregiver Training Program for caregivers of people with dementia, using a pretest posttest randomized control trial with 3-month follow-up. The Family Caregiver Training Program will consist of 3-hours and hence, three modules over the course of one day. Module one will present information on communication, eating, and nutrition, module two will focus on transfers and toileting, and module three will focus on bathing, grooming, and dressing. The control group will receive standard care as relevant to dementia family caregivers including general information on the progression of dementia, and helpful resources as suggested by the Alzheimer's Association. A convenience sample of 36 family caregivers will be recruited by flyers posted throughout local area community boards and Alzheimer's Association media outlets. A repeated measures ANOVA will be used to assess the group differences in knowledge and confidence at three time points (pre-intervention, post-intervention, and 3-months post-intervention). Changes in caregiver burden, depression, quality of life, and occupational performance and satisfaction will be assessed 3-months post-intervention.

详细描述

The main research question asks to what extent does participation in a structured 3-hour training module (i.e., The Family Caregiver Training Program) focused on assisting family caregiver's with the ADLs of people with dementia effect caregiver knowledge and confidence, which in turn may effect caregiver burden, depression, quality of life, and occupational performance and satisfaction. Aim 1 will examine the relationship between the Family Caregiver Training Program intervention and knowledge of and confidence in the occupation of caregiving. Aim 2 will explore the relationship between the occupation of caregiving and person characteristics including burden, depression, and quality of life. Aim 3 will explore the relationship between the changes in the occupation of caregiving and changes in occupational performance.

A feasibility of the Family Caregiver Training Program was established using a single pre- post- test design. A significant improvement in caregiver knowledge was found in all three areas of training: communication/nutrition (N=53, p<0.001), transfers and toileting (N=46, p=0.003), and bathing and dressing (N=45, p=0.10) (DiZazzo-Miller, Samuel, Barnas, & Welker, 2014). This proposed study is built on the feasibility study, with the addition of confidence, burden, depression, quality of life, and occupational performance and satisfaction as outcomes using a random assignment to control group design.

A convenience sample of 36 family caregivers was recruited through flyers, newsletters, and Alzheimer's Association media outlets. The intervention group received one two-hour training that included three modules. Module one presented information on communication, eating/feeding and nutrition; module two focused on transfers and toileting; and module three focused on bathing, grooming, and dressing. The control group received standard care based upon a packet developed by the Alzheimer's Association for physicians to distribute to families and caregivers after receiving a diagnosis of dementia.

Results from this study will be generalizable to Metro-Detroit area family caregivers. Findings may offer information to enhance the caregiver training literature in the field of occupational therapy on the impact a community-based activity of daily living training can have with dementia family caregivers.

研究设计

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

入排标准

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

入选标准

  • Primary family caregiver as providing at least 4 hours/day of care at least 5 days/week
  • At least 18 years of age
  • Able to read and understand the English language
  • Care recipients must have received an Alzheimer's or related dementia diagnosis

排除标准

  • Caregivers who provide less than 4 hours/day of care at least 5 days/week
  • Under 18 years of age
  • Unable to read or understand the English language
  • Have care recipients who have not received an Alzheimer's or related dementia diagnosis
  • Formally trained/paid caregivers

结局指标

主要结局

Caregiver Change in Activities of Daily Living Knowledge

时间窗: Pretest (i.e., immediately before training) to Posttest (i.e., immediately after training-on the same day) and 3-Months Posttest.

The ADL Knowledge Test is an 18-item, multiple-choice measure of caregiver assistance.

Caregiver Change in Confidence

时间窗: Pretest (i.e., immediately before training) to Posttest (i.e., immediately after training-on the same day) and 3-Months Posttest.

The Caregiver Confidence Scale (Lewis et al., 2010) is a modified nine-item confidence scale used to assess caregiver confidence in their skills for caring, understanding of the stages of dementia, and communication with their care recipient.

次要结局

  • The Zarit Burden Interview (22-item)(Pretest and 3-months posttest)
  • The Beck Depression Inventory II(Pretest and 3-months posttest)
  • WHOQOL-BREF(Pretest and 3-months posttest)
  • Occupational Performance(Pretest and 3-months posttest)
  • Occupational Satisfaction(Pretest and 3-months posttest)

研究者

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

Rosanne DiZazzo-Miller

PhD Candidate

Nova Southeastern University

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