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临床试验/NCT04139707
NCT04139707Unknown不适用

An Information and Computer Technology-based Mobile Application for Training of Family Members Caring for Someone With Dementia

University of Manitoba1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年1月2日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Change in caregiver well-being

研究概览

简要总结

Background

The mental, physical, and emotional health of caregivers is negatively affected by the burden of caring for of persons living with dementia. Caregivers are usually reported as feeling frustrated, angry, exhausted, guilty, helpless and unable to bear the heavy burden of their caregiving responsibilities. In addition to depressive symptoms and other mental health problems among caregivers, the physical stress of caring for someone who is unable to perform daily activities such as bathing, grooming and other personal care, has been shown to be a serious threat to caregivers' physical health outcomes. Evidence has shown that greater levels of stress, anxiety, depression, frustration, and lower subjective well-being and self-efficacy are exhibited in a greater amount among family and friends who care for persons living with dementia compared to those who do not have the burden of caring for a persons living with dementia. Caregivers have been shown to use alcohol and other drugs at a higher rate than those who do not need to care for others as a reaction to this increased stress. Studies has also shown that caregivers are more likely than non-Caregivers to use opioid or psychotropic medications. One over five caregivers (22%) feel tired when they go to bed at night.

Objectives

This study relies on a mobile application (Caring4Dementia) that provides people, caring for a person living with dementia, with a useful and intuitive training tool targeting communication skills. The aims of this study are to evaluate the feasibility and acceptability of using Caring4Dementia within a self-administered program and the preliminary efficacy of the Caring4Dementia intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

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

  • Informal caregiver of a person living with dementia for more than 6 months
  • Able to read and understand English
  • Able to use smartphones and tablets (Apple or Android)
  • Have a smartphone or tablet (Apple or Android) with internet connection, involved in this study
  • 18 years or over
  • Give written and oral informed consent

排除标准

  • 未提供

结局指标

主要结局

Change in caregiver well-being

时间窗: Baseline (Day 1), post (day 30), Retention (90 days) after baseline

Measured by the Caregiver Well-Being Scale to determine the frequency in which basic needs and activities of living have been met for the caregiver within the last three months. Items in this self-reported scale are scored on a 5-point scale \[ranging form "Rarely (1)" to "Usually (5)"\], with a higher dimension score indicating greater intensity in that dimension. The highest score possible is 70, meaning a higher well-being.

次要结局

  • Change in caregivers' perceived challenges and resources(Baseline (Day 1), post (day 30), Retention (90 days) after baseline)
  • Activity frequency on the Caring4Dementia app(30 days)
  • Activity volume on the Caring4Dementia app(30 days)
  • Change in caregiver burden(Baseline (Day 1), post (day 30), Retention (90 days) after baseline)

研究者

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

Amine Choukou

Assistant Professor

University of Manitoba

研究点 (1)

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