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临床试验/NCT03645694
NCT03645694已完成2 期

Social Support Aid For People With Dementia

University of Minnesota0 个研究点目标入组 48 人开始时间: 2016年11月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
48
主要终点
Change in Dementia Quality of Life

研究概览

简要总结

The goal of this study is to determine the acceptability, utility, and preliminary effectiveness of a facial recognition technology for persons with memory concerns and their family care partners.

详细描述

This project develops a novel social support aid (SSA) to allow persons with memory concerns (PWMCs) to more fully engage in their social network and enhance their quality of life. The SSA will assist people in an early stage of dementia, e.g., Alzheimer's disease or related dementia, who desire social interaction, but struggle to remember names and relationships. It provides memory cuing by displaying the names and relationships of the people with whom PWMCs are engaged. The investigators anticipate that the SSA will offer robust support for care partners and PWMCs in various communities. The SSA is not intended to replace caregiver aids, but rather augment them to further improve quality of life. Millions of Americans have dementia, the loss of mental functions, e.g., thinking, memory, and reasoning, which interferes with their daily functioning. While some cases of dementia are caused by medical conditions that can be treated, most cannot be reversed. Hence, the focus switches from treatment to palliative care, i.e., developing a plan to make life easier and more comfortable for individuals with dementia and their caregivers. Assistive technologies to enhance living with dementia, let alone studies that evaluate their efficacy, are underdeveloped. The proposed project aims to begin filling this scientific and clinical gap by developing a social support aid and formally evaluating its utility via a sufficiently powered randomized controlled trial.

This phase II Small Business Innovation Research project will continue work started in phase I and complete a product. The aim of this human subjects research protocol is to evaluate whether the SSA exerts positive benefits for PWMCs' social connections, communication, and quality of life via an embedded experimental mixed methods design that combines the collection and analysis of qualitative data within a traditional randomized controlled trial (RCT) design. The investigators hypothesize that the proposed SSA will exert positive benefits on the social connections, communication, and quality of life of people in early stage dementia.

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
None

入排标准

年龄范围
21 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • PWMCs must be:
  • A physician diagnosis of early-stage Alzheimer's disease, mild cognitive impairment, or a self-identified concern of memory loss.
  • Able to complete surveys in English or Spanish
  • SLUMS score of 20 or above
  • Care partners of PWMCs must be:
  • 21 years of age and over;
  • self-identify as someone who provides assistance to the PWMC because of their memory loss (these individuals are called ''care partners,'' as these individuals may or may not provide the intensive hands-on care typical of ''caregivers'');
  • indicate a willingness to use the SSA

排除标准

  • Indicates an unwillingness to use the SSA.

结局指标

主要结局

Change in Dementia Quality of Life

时间窗: Baseline, 3-months, and 6-months

The 21-item modified Dementia Quality of Life instrument is a self-report survey that assesses various domains of quality of life in the person wtih dementia.

Change in Cantril quality of life ladder

时间窗: Baseline, 3-months, and 6-months

The Cantril quality of life ladder is a single item survey that asks respondents to rate their overall quality of life on a scale of 0 (bottom of the latter) to 10 (top of the ladder).

次要结局

  • Change in the frequency and quality of social interactions of persons with memory concerns(Baseline, 3-months, and 6-months)
  • Pleasant events and activities of person with memory concerns(3-months and 6-months)

研究者

申办方类型
Other
责任方
Sponsor

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