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A Mobile Informatics Solution to Assist Caregivers in Care Coordination and Monitoring Social Engagement

2026年8月14日 更新者：University of Minnesota

This study will evaluate the Social Reminder System, a mobile informatics system designed to support persons with memory concerns and their care partners. The system is intended to aid social integration for persons with memory concerns and improve care coordination and reduce caregiver burden among caregivers.

Researchers will enroll 100 persons with memory concerns and their care partners. Half of the dyads will be randomly assigned to receive the Social Reminder System technology for a 6-month period, and the other half will be randomly assigned to the usual care control group. Participants will complete baseline, 3-month, and 6-month surveys. A subset of participants who receive the technology will also be asked to complete a semi-structured interview after the 6-month survey.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

The Social Reminder System has two goals. The first is to aid in the social integration of persons with memory concerns. The second is to improve care coordination and reduce caregiver burden among caregivers. Following a randomized control trial design, the study will assess the impact of the Social Reminder System on both persons with memory concerns and their care partners.

The Social Reminder System app is designed to provide memory prompts to persons with memory concerns on an in-home tablet before and during social visits. Individuals who are part of a person with memory concerns' trusted circle may download a free smartphone app and save a photo of themselves, their names, and familial relationship description that are shared with the person with memory concerns' display. When trusted circle members are within a 10-meter range of the tablet, the person with memory concerns receives a notification that a visitor is in range. The notification includes a photo of the visitor, the visitor's name, and information about their relationship to the person with memory concerns. Reminders continue to appear on the tablet throughout the visit and cease once the visitor is out of range.

The phase 2b technology also allows the person with memory concerns to designate a primary caregiver. For security reasons and to promote care coordination, the care partner will receive a log of visitors who opted in as trusted circle members. The log will include names, dates, and beginning and ending times of each visit.

A total of 100 dyads, consisting of persons with memory concerns and their care partners, will be enrolled. Half of the dyads will be randomly assigned to the Social Reminder System intervention group and half to an attention control group. Participants will complete baseline, 3-month, and 6-month surveys. The baseline survey will be administered before exposure to the intervention or attention control. Follow-up surveys will be administered 3 months and 6 months after enrollment.

The study will also include semi-structured interviews with a subset of dyads randomly assigned to receive the Social Reminder System. Interviews will take place after completion of the final 6-month follow-up survey and will focus on overall reactions to the technology, perceived barriers to engagement with the technology, and short- and long-term outcomes of engagement with the technology that may have been missed in the survey instruments.

研究类型

介入性

注册 (估计的)

200

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • Minnesota
      • Minneapolis、Minnesota、美国、55455
        • University of Minnesota
        • 首席研究员：
          • Jude Mikal, PhD
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Persons with memory concerns must be English speaking.
  • Persons with memory concerns must self-report a healthcare provider visit due to memory concerns or memory related diagnosis by a physician or other qualified health care provider consistent with having mild-to-moderate memory impairment.
  • Persons with memory concerns must be over the age of 65.
  • Persons with memory concerns must be able to formally consent or assent to participate in the study.
  • Persons with memory concerns must have internet access.
  • Care partners of persons with memory concerns must speak English.
  • Care partners must be 18 years of age and over.
  • Care partners must self-identify as the primary caregiver for the person with memory concerns.
  • Care partners must indicate a willingness to use the Social Reminder System as well as to being randomized to a control group.
  • Care partners must have a mobile phone with internet access in order to install and use the care partner app.

Exclusion Criteria:

  • Those who do not meet the criteria above will be excluded.
  • Persons with memory concerns with severe or no dementia are not eligible.
  • Individuals who score below 6 and above 24 on the TICS-40 will not be eligible.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Social Reminder System
Dyads randomly assigned to this arm will receive the Social Reminder System technology for a 6-month period. The Social Reminder System app is designed to provide memory prompts to persons with memory concerns on an in-home tablet before and during social visits. Care partners will also receive a log of visitors to promote care coordination.
行为的：Social Reminder System
The Social Reminder System app is designed to provide memory prompts to persons with memory concerns on an in-home tablet before and during social visits. Individuals who are part of a person with memory concerns' trusted circle may download a free smartphone app and save a photo of themselves, their names, and familial relationship description that are shared with the person with memory concerns' display. When trusted circle members are within a 10 meter range of the tablet, the person with memory concerns receives a notification that a visitor is in range. Reminders continue to appear on the tablet throughout the visit and cease once the visitor is out of range. The care partner will also receive a log of visitors, including names, dates, and beginning and ending times of each visit.
无干预：Usual Care Control
Dyads randomly assigned to this arm will receive usual care control. The attention control group will receive a 3-month contact call and a 6-month contact call from the research coordinator. Free information resources, such as brochures or websites of the Alzheimer's Association, may be provided.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Social Interaction Frequency and Quality
大体时间：Baseline to 6 months
Change in frequency and quality of social interactions reported by persons with memory concerns and care partners, including in-person visits, phone calls, mail and letters, and computer-mediated communication.
Baseline to 6 months
Change in Pleasant Events and Social Engagement as Assessed by the Pleasant Events Schedule-Alzheimer's Disease
大体时间：Baseline to 6 months
Change in pleasant events and social engagement for persons with memory concerns, assessed using the Pleasant Events Schedule-AD.
Baseline to 6 months
Change in Social Support Score
大体时间：Baseline to 6 months
Change in social support among persons with memory concerns and care partners, assessed using a five-item social support scale.
Baseline to 6 months
Change in Loneliness
大体时间：Baseline to 6 months
Change in loneliness among persons with memory concerns and care partners, assessed using the UCLA Loneliness Scale.
Baseline to 6 months
Change in Caregiver Burden
大体时间：Baseline to 6 months
Change in caregiver burden among care partners, assessed using the Zarit Burden Interview.
Baseline to 6 months
Change in Role Captivity Score
大体时间：Baseline to 6 months
Change in role captivity among care partners, assessed using a 4-item role captivity scale.
Baseline to 6 months
Change in Role Overload Score
大体时间：Baseline to 6 months
Change in role overload among care partners, assessed using a 3-item role overload scale.
Baseline to 6 months
Change in Anxiety as Assessed by the Hospital Anxiety and Depression Scale
大体时间：Baseline to 6 months
Change in anxiety among persons with memory concerns and care partners, assessed using the Hospital Anxiety and Depression Scale.
Baseline to 6 months
Change in Depression as Assessed by the Hospital Anxiety and Depression Scale
大体时间：Baseline to 6 months
Change in depression among persons with memory concerns and care partners, assessed using the Hospital Anxiety and Depression Scale.
Baseline to 6 months

次要结果测量

结果测量
措施说明
大体时间
Perceived Function, Utility, and Barriers to Engagement With the Social Reminder System
大体时间：Up to 1 month after completion of the 6-month follow-up survey
Semi-structured interviews will assess overall reactions to the Social Reminder System, perceived barriers to engagement with the technology, and short- and long-term outcomes of engagement with the technology that may have been missed in the survey instruments.
Up to 1 month after completion of the 6-month follow-up survey
Change in Service Utilization Among Persons With Memory Concerns
大体时间：Baseline to 6 months
Change in service utilization among persons with memory concerns, including nursing home, assisted living, other residential care, hospital stays, and emergency department visits.
Baseline to 6 months
Change in Negative Health Transitions Among Persons With Memory Concerns
大体时间：Baseline to 6 months
Change in negative health transitions among persons with memory concerns, including falls and wandering events, assessed by care partner report.
Baseline to 6 months
Change in Quality of Life as Assessed by the Adapted Quality of Life-Alzheimer's Disease Measure
大体时间：Baseline to 6 months
Change in quality of life for persons with memory concerns and care partners, assessed using the adapted Quality of Life-Alzheimer's Disease measure.
Baseline to 6 months
Change in Community Engagement as Assessed by the 15-Item Community Engagement Scale
大体时间：Baseline to 6 months
Change in community engagement among persons with memory concerns and care partners, assessed using a 15-item scale evaluating frequency, duration, and location of trips outside the home.
Baseline to 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Minnesota

合作者

National Institute on Aging (NIA)

调查人员

  • 首席研究员：Jude Mikal, PhD、University of Minnesota

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2028年3月1日

研究完成 (估计的)

2028年6月1日

研究注册日期

首次提交

2026年8月13日

首先提交符合 QC 标准的

2026年8月14日

首次发布 (实际的)

2026年8月19日

研究记录更新

最后更新发布 (实际的)

2026年8月19日

上次提交的符合 QC 标准的更新

2026年8月14日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • Study00027433
  • 2R44AG063683-04 (美国 NIH 拨款/合同)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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