Clinical trial NCT04700540: A Mobile Informatics Solution to Aid in Memory
Official title: A Mobile Informatics Solution to Aid in Memory
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Dementia
Keywords: Dementia
Alzheimer Disease
Social Interaction
Quality of Life
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Advanced Medical Electronics
name: University of Michigan
name: Brown University
First posted: 2021-01-08
Enrollment: 162
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: PWMC Loneliness
timeFrame: 3 months
measure: PWMC Social Relationships and Social Support
timeFrame: 3 months
Secondary outcomes:
measure: PWMC Physical and Mental Well-being
timeFrame: 3 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References: