跳至主要内容
临床试验/NCT04700540
NCT04700540已完成不适用

A Mobile Informatics Solution to Aid in Memory

University of Minnesota1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2022年9月1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
162
试验地点
1
主要终点
PWMC Loneliness

研究概览

简要总结

The researchers propose to develop an informatics system to assist people with memory impairment. Persons with Memory Concern (PWMC) recognize the faces they see daily, such as a spouse or caregiver, but they may confuse visiting friends and grandchildren or they may not match names with faces well. The inability to remember names or relationships contributes to isolation and deeply affects their social lives. The proposed solution is a Smartwatch Reminder (SR) system to conspicuously provide this information to the PWMC when needed. The system will be evaluated on the target persons with memory concern population to measure engagement and improvements in social interactions and quality of life.

详细描述

This research will evaluate technology designed to improve the quality of life for persons with dementia through external aids to assist with remembering. The primary goal of the Smartwatch Reminder (SR) is to facilitate social interaction for Persons with Memory Concern (PWMC) by providing facial recognition of family, friends, and other key people. The SR will be evaluated using an embedded experimental mixed methods design that combines the collection and analysis of qualitative data within a traditional randomized controlled trial design. To do so, researchers will enroll 100 PWMC and their care partners to participate in initial, 3-month, and 6-month surveys. Half of the PWMCs will be randomly assigned to the intervention group (i.e. receive the SR) and the other half randomly assigned to the attention control group. Each participant will take part in the study for a total of 6 months. All study procedures and data analysis are anticipated to be completed within 24 months.

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 (Outcomes Assessor)

入排标准

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

入选标准

  • •for PWMC are as follows:
  • •English speaking
  • •a physician diagnosis of early-stage Alzheimer's disease or mild-to-moderate cognitive impairment
  • •no history of serious mental illness (i.e., any major psychiatric disorder)
  • •Inclusion criteria for care partners of PWMC are as follows:
  • •English speaking
  • •21 years of age or over
  • •self-identifies 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'')
  • •plans to remain in the area for at least 6 months in order to reduce loss to follow-up
  • •indicates a willingness to use the smartwatch system

排除标准

  • •for PWMC are as follows:
  • •non-English speaking
  • •no physician diagnosis of early-stage Alzheimer's disease or mild-to-moderate cognitive impairment
  • •a history of serious mental illness (i.e., any major psychiatric disorder)
  • •Exclusion criteria for care partners of PWMC are as follows:
  • •non-English speaking
  • •under 21 years of age
  • •does not identify as someone who provides assistance to the PWMC because of their memory loss
  • •does not plan on remaining in the area for at least 6 months
  • •does not indicate a willingness to use the smartwatch system

研究组 & 干预措施

Intervention Group

Experimental

The PWMC and Care partner in this group will receive the SR. The project will provide a smartwatch and smartphone for the dyads in the study. All others (family, friends, etc.) will be able to download a smartphone app from an online store. Instructional material will be created to show the suggested information that can be entered into the app. Care partners and PWMC are administered surveys at baseline and 3 months following enrollment.

干预措施: Smartwatch Reminder (SR) system (Device)

Attention Control Group

No Intervention

Care partners are administered surveys at baseline and 3 months following enrollment. The attention control group will receive a contact call from one of the researchers 3-months after enrollment. Based on our prior experience, PWMC and care partners in an attention control group will often seek information and psychosocial support during these calls. We will provide free information resources (e.g., brochures or websites of the Alzheimer's Association) at that time.

结局指标

主要结局

PWMC Loneliness

时间窗: 3 months

Original three-item measure, including: * How often do you feel you lack companionship? * How often do you feel left out? * How often do you feel isolated from others? Scale range 3-9, higher scores indicate higher rates of social isolation.

PWMC Social Relationships and Social Support

时间窗: 3 months

The Lubben Social Network Scale (LSNS) is a measure of social relationships and social support networks. We used the shortened 6-item scale to reduce test burden. The 6-item scale has a range of 0 - 30 with higher scores indicating more robust social networks / access to support.

次要结局

  • PWMC Physical and Mental Well-being(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验