A Mobile Informatics Solution to Aid in Memory

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Mobile Informatics Solution to Aid in Memory

Conditions
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Alzheimer Disease, Dementia

Intervention / Treatment
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* Device: Smartwatch Reminder (SR) system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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, 3 months and 6 months following enrollment. | Device: Smartwatch Reminder (SR) system<br>* 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.<br>|
| No Intervention: Attention Control Group<br>Care partners are administered surveys at baseline, 3 months and 6 months following enrollment. The attention control group will receive a contact call from one of the researchers 3-months and 6-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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PWMC Social Interaction Frequency | 8-item measure of the frequency of the PWMC's social interactions | Baseline, 3-, and 6-months | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Change in Negative Health Transitions | 1-item to assess change in living or care situation and mortality | Baseline, 3-, and 6-months | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia, Alzheimer Disease, Social Interaction, Quality of Life