A Mobile Informatics Solution to Aid in Memory

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Alzheimer Disease
• Intervention / Treatment: Device: Smartwatch Reminder (SR) system

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria 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

Exclusion Criteria 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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.	Device: Smartwatch Reminder (SR) system; The Smartwatch Reminder (SR) system will automatically transmit pictures and relevant information, such as name or relationship, to a smartwatch worn by the PWMC when family or friends visit.
No Intervention: Attention Control Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PWMC Loneliness	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.	3 months
PWMC Social Relationships and Social Support	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PWMC Physical and Mental Well-being	We used the Global Health Scale. This tool is designed to assess an individual's overall physical and mental wellbeing. The scale measures subjective health perceptions. Scale scores range from 0 - 100, with higher scores indicating higher rates of mental and physical well-being.	3 months

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: Brown University; University of Michigan; Advanced Medical Electronics

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Quality of Life; Dementia; Alzheimer Disease; Social Interaction
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; Dementia
• Other Study ID Numbers: SPH-2023-31117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Public access to the research data generated from this project will be offered via de-identified data files maintained by the investigators. All personal identifiers of family caregivers of persons with Alzheimer's disease or a related dementia (ADRD) participating in the study will be removed and replaced with random identification numbers prior to distributing data files. Potential external investigators will be asked to complete a data use agreement and a recommended citation to these materials will be provided. Data from the project will be maintained on a secure University of Minnesota School of Public Health shared server for 3 years following study completion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No