A Mobile Informatics Solution to Aid in Memory

Alzheimer Disease Clinical Trial

Official title:

A Mobile Informatics Solution to Aid in Memory

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04700540
• Other study ID #: STUDY00006318
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: April 1, 2024

Study information

• Verified date: April 2024
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
University of Minnesota	Advanced Medical Electronics, Brown University, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PWMC Social Interaction Frequency	8-item measure of the frequency of the PWMC's social interactions	Baseline, 3-, and 6-months
Primary	Change in PWMC Social Interaction Quality	8-item measure of the quality of the PWMC's social interactions (scores range from 8 to 40; higher scores suggest greater satisfaction with social interactions)	Baseline, 3-, and 6-months
Primary	Change in PWMC Quality of Life	21-item adapted Dementia Quality of Life (DQoL) measure (scores range from 0 to 105; higher scores indicate higher quality of life)	Baseline, 3-, and 6-months
Secondary	Change in Care Partner Psychosocial Well-Being	11-item Eriksonian Psychosocial Stage Inventory (scores range from 11 to 55; higher scores suggest greater well-being)	Baseline, 3-, and 6-months
Secondary	Change in Care Partner Depression	10-item Center for Epidemiological Studies - Depression Scale (scores range from 0 to 30; higher scores suggest more severe depression symptoms)	Baseline, 3-, and 6-months
Secondary	Change in Social Support	8-item scale to assess affective assistance by care partner's social network (scores range from 8 to 40; higher scores suggest higher affective assistance by social network)	Baseline, 3-, and 6-months
Secondary	Change in Social Engagement	6-item Lubben Social Network Scale (LSNS-6) (scores range from 0 to 30; higher scores suggest higher risk of social isolation)	Baseline, 3-, and 6-months
Secondary	Change in Negative Health Transitions	1-item to assess change in living or care situation and mortality	Baseline, 3-, and 6-months
Secondary	Change in Relationship Quality	6-item version of the Relationship Assessment Scale (scores range from 0 to 30; higher scores suggest higher satisfaction with the relationship)	Baseline, 3-, and 6-months
Secondary	Change in Pleasant Events Schedule	20-items adapted measure of events and activities (PES-AD) (scores range from 0 to 60; higher scores suggest greater enjoyment with events and activities)	Baseline, 3-, and 6-months
Secondary	Change in Community Engagement	15-item survey developed to evaluate the PWMC's typical social interactions and destinations accessed outside of the home (scores range from 0 to 75; higher scores indicate greater community engagement)	Baseline, 3-, and 6-months
Secondary	Change in PWMC Functional Status	12-item survey to assess Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) (scores range from 0 to 36; higher scores indicate greater impairment in function)	Baseline, 3-, and 6-months
Secondary	Change in Memory Impairment	8-item survey to evaluate level of memory impairment of PWMC (scores range from 8 to 40; higher scores indicate greater memory impairment)	Baseline, 3-, and 6-months
Secondary	Change in Care Partner Reactions to Memory and Behavioral Problems	24-item Revised Memory and Behavior Problem Checklist (scores range from 0 to 96; higher scores indicate greater distress associated with problems)	Baseline, 3-, and 6-months
Secondary	Change in Care Partner Quality of Life Ladder	Cantril's Ladder (scores range from 0 to 10; higher scores suggest higher quality of life)	Baseline, 3-, and 6-months
Secondary	Change in Care Partner Loneliness in Relationship	UCLA Loneliness Scale (scores range from 20 to 80; higher scores indicate greater loneliness)	Baseline, 3-, and 6-months