A Mobile Informatics Solution to Aid in Memory

University of Minnesota (UMN)

Status: Completed

Conditions: Alzheimer Disease; Dementia

Treatments: Device: Smartwatch Reminder (SR) system

Study type: Interventional

Funder types: Other

Identifiers

NCT04700540

SPH-2023-31117

Details and patient eligibility

About

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.

Full 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.

Enrollment: 162 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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162 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Device: Smartwatch Reminder (SR) system

Attention Control Group

No Intervention group

Description:

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.