A Mobile Informatics Solution to Aid in Memory

NCT ID: NCT04700540

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-04-01

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.

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.

Conditions

Alzheimer Disease; Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Smartwatch Reminder (SR) system

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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
• 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

• 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Advanced Medical Electronics

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

SPH-2023-31117

Identifier Type: -

Identifier Source: org_study_id