A Mobile Informatics Solution to Aid in Memory

NCT04700540 | Completed Results DMC

• 1 other identifier: SPH-2023-31117
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease; Dementia

Keywords

Dementia; Alzheimer Disease; Social Interaction; Quality of Life

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• PWMC Physical and Mental Well-being

  3 months

Study Arms (2)

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.

Device: Smartwatch Reminder (SR) system

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.

Interventions

Smartwatch Reminder (SR) system DEVICE

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.

Intervention Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• English speaking
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University of Minnesota: lead
• Advanced Medical Electronics: collaborator
• University of Michigan: collaborator
• Brown University: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Jude Mikal
• Organization: University of Minnesota

jpmikal@umn.edu

385-212-4185

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 (to receive the SR) and the other half randomly assigned to the attention control group.

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: January 8, 2021
• Study Start: September 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: March 26, 2025
• Results First Posted: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)