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A Mobile Informatics Solution to Aid in Memory

Primary Purpose

Alzheimer Disease, Dementia

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Smartwatch Reminder (SR) system

About this trial

This is an interventional supportive care trial for Alzheimer Disease focused on measuring Dementia, Alzheimer Disease, Social Interaction, Quality of Life

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Attention Control Group

Arm 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, 3 months and 6 months following enrollment.

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.

Outcomes

Primary Outcome Measures

Change in PWMC Social Interaction Frequency

8-item measure of the frequency of the PWMC's social interactions

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)

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)

Secondary Outcome Measures

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)

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)

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)

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)

Change in Negative Health Transitions

1-item to assess change in living or care situation and mortality

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)

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)

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)

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)

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)

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)

Change in Care Partner Quality of Life Ladder

Cantril's Ladder (scores range from 0 to 10; higher scores suggest higher quality of life)

Change in Care Partner Loneliness in Relationship

UCLA Loneliness Scale (scores range from 20 to 80; higher scores indicate greater loneliness)

Full Information

NCT ID

NCT04700540

First Posted

December 17, 2020

Last Updated

September 4, 2023

Sponsor

University of Minnesota

Collaborators

Advanced Medical Electronics, University of Michigan, Brown University

1. Study Identification

Unique Protocol Identification Number

NCT04700540

Brief Title

A Mobile Informatics Solution to Aid in Memory

Official Title

A Mobile Informatics Solution to Aid in Memory

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 1, 2022 (Actual)

Primary Completion Date

April 30, 2024 (Anticipated)

Study Completion Date

April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

Collaborators

Advanced Medical Electronics, University of Michigan, Brown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease, Dementia

Keywords

Dementia, Alzheimer Disease, Social Interaction, Quality of Life

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Outcomes Assessor

Allocation

Randomized

Enrollment

162 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

Arm Title

Attention Control Group

Arm Type

No Intervention

Arm Description

Intervention Type

Device

Intervention Name(s)

Smartwatch Reminder (SR) system

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in PWMC Social Interaction Frequency

Description

8-item measure of the frequency of the PWMC's social interactions

Time Frame

Baseline, 3-, and 6-months

Title

Change in PWMC Social Interaction Quality

Description

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)

Time Frame

Baseline, 3-, and 6-months

Title

Change in PWMC Quality of Life

Description

21-item adapted Dementia Quality of Life (DQoL) measure (scores range from 0 to 105; higher scores indicate higher quality of life)

Time Frame

Baseline, 3-, and 6-months

Secondary Outcome Measure Information:

Title

Change in Care Partner Psychosocial Well-Being

Description

11-item Eriksonian Psychosocial Stage Inventory (scores range from 11 to 55; higher scores suggest greater well-being)

Time Frame

Baseline, 3-, and 6-months

Title

Change in Care Partner Depression

Description

10-item Center for Epidemiological Studies - Depression Scale (scores range from 0 to 30; higher scores suggest more severe depression symptoms)

Time Frame

Baseline, 3-, and 6-months

Title

Change in Social Support

Description

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)

Time Frame

Baseline, 3-, and 6-months

Title

Change in Social Engagement

Description

6-item Lubben Social Network Scale (LSNS-6) (scores range from 0 to 30; higher scores suggest higher risk of social isolation)

Time Frame

Baseline, 3-, and 6-months

Title

Change in Negative Health Transitions

Description

1-item to assess change in living or care situation and mortality

Time Frame

Baseline, 3-, and 6-months

Title

Change in Relationship Quality

Description

6-item version of the Relationship Assessment Scale (scores range from 0 to 30; higher scores suggest higher satisfaction with the relationship)

Time Frame

Baseline, 3-, and 6-months

Title

Change in Pleasant Events Schedule

Description

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)

Time Frame

Baseline, 3-, and 6-months

Title

Change in Community Engagement

Description

Time Frame

Baseline, 3-, and 6-months

Title

Change in PWMC Functional Status

Description

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)

Time Frame

Baseline, 3-, and 6-months

Title

Change in Memory Impairment

Description

8-item survey to evaluate level of memory impairment of PWMC (scores range from 8 to 40; higher scores indicate greater memory impairment)

Time Frame

Baseline, 3-, and 6-months

Title

Change in Care Partner Reactions to Memory and Behavioral Problems

Description

24-item Revised Memory and Behavior Problem Checklist (scores range from 0 to 96; higher scores indicate greater distress associated with problems)

Time Frame

Baseline, 3-, and 6-months

Title

Change in Care Partner Quality of Life Ladder

Description

Cantril's Ladder (scores range from 0 to 10; higher scores suggest higher quality of life)

Time Frame

Baseline, 3-, and 6-months

Title

Change in Care Partner Loneliness in Relationship

Description

UCLA Loneliness Scale (scores range from 20 to 80; higher scores indicate greater loneliness)

Time Frame

Baseline, 3-, and 6-months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Public access to the research data generated from this project will be offered via de-identified data files maintained by the investigators. All personal identifiers of family caregivers of persons with Alzheimer's disease or a related dementia (ADRD) participating in the study will be removed and replaced with random identification numbers prior to distributing data files. Potential external investigators will be asked to complete a data use agreement and a recommended citation to these materials will be provided. Data from the project will be maintained on a secure University of Minnesota School of Public Health shared server for 3 years following study completion.

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A Mobile Informatics Solution to Aid in Memory

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