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Social Support Aid For People With Dementia

Primary Purpose

Dementia, Memory Loss

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Social Support Aid
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia focused on measuring Caregiving, Technology, Social support

Eligibility Criteria

21 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

PWMCs must be:

  • A physician diagnosis of early-stage Alzheimer's disease, mild cognitive impairment, or a self-identified concern of memory loss.
  • Able to complete surveys in English or Spanish
  • SLUMS score of 20 or above

Care partners of PWMCs must be:

  • 21 years of age and over;
  • self-identify 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'');
  • indicate a willingness to use the SSA

Exclusion Criteria:

  • Indicates an unwillingness to use the SSA.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    SSA

    Control

    Arm Description

    Individuals with memory concerns in the experimental arm received the prototype facial recognition technology, which included a smartphone and smartwatch. The smartphone was equipped with facial recognition software application; the smartwatch communicated information with the smartphone. Persons with memory concerns and their family care partners were given a demonstration on how to utilize the technology.

    Control participants did not receive the technology; at the conclusion of follow-up, all controls were offered the technology to use.

    Outcomes

    Primary Outcome Measures

    Change in Dementia Quality of Life
    The 21-item modified Dementia Quality of Life instrument is a self-report survey that assesses various domains of quality of life in the person wtih dementia.
    Change in Cantril quality of life ladder
    The Cantril quality of life ladder is a single item survey that asks respondents to rate their overall quality of life on a scale of 0 (bottom of the latter) to 10 (top of the ladder).

    Secondary Outcome Measures

    Pleasant events and activities of person with memory concerns
    The Pleasant Events and Activities-AD Schedule Short Form is a 17-item self-report survey that measures the degree of enjoyment persons with dementia have engaging in a range of activities.
    Change in the frequency and quality of social interactions of persons with memory concerns
    Series of weekly, self-report calendar measures on types and quality of social interactions, developed for this study.

    Full Information

    First Posted
    August 17, 2018
    Last Updated
    April 13, 2022
    Sponsor
    University of Minnesota
    Collaborators
    Advanced Medical Electronics, National Institute on Aging (NIA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03645694
    Brief Title
    Social Support Aid For People With Dementia
    Official Title
    Social Support Aid For People With Dementia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2016 (Actual)
    Primary Completion Date
    August 15, 2018 (Actual)
    Study Completion Date
    August 15, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Minnesota
    Collaborators
    Advanced Medical Electronics, National Institute on Aging (NIA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this study is to determine the acceptability, utility, and preliminary effectiveness of a facial recognition technology for persons with memory concerns and their family care partners.
    Detailed Description
    This project develops a novel social support aid (SSA) to allow persons with memory concerns (PWMCs) to more fully engage in their social network and enhance their quality of life. The SSA will assist people in an early stage of dementia, e.g., Alzheimer's disease or related dementia, who desire social interaction, but struggle to remember names and relationships. It provides memory cuing by displaying the names and relationships of the people with whom PWMCs are engaged. The investigators anticipate that the SSA will offer robust support for care partners and PWMCs in various communities. The SSA is not intended to replace caregiver aids, but rather augment them to further improve quality of life. Millions of Americans have dementia, the loss of mental functions, e.g., thinking, memory, and reasoning, which interferes with their daily functioning. While some cases of dementia are caused by medical conditions that can be treated, most cannot be reversed. Hence, the focus switches from treatment to palliative care, i.e., developing a plan to make life easier and more comfortable for individuals with dementia and their caregivers. Assistive technologies to enhance living with dementia, let alone studies that evaluate their efficacy, are underdeveloped. The proposed project aims to begin filling this scientific and clinical gap by developing a social support aid and formally evaluating its utility via a sufficiently powered randomized controlled trial. This phase II Small Business Innovation Research project will continue work started in phase I and complete a product. The aim of this human subjects research protocol is to evaluate whether the SSA exerts positive benefits for PWMCs' social connections, communication, and quality of life via an embedded experimental mixed methods design that combines the collection and analysis of qualitative data within a traditional randomized controlled trial (RCT) design. The investigators hypothesize that the proposed SSA will exert positive benefits on the social connections, communication, and quality of life of people in early stage dementia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dementia, Memory Loss
    Keywords
    Caregiving, Technology, Social support

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Individual with memory concerns and their family caregivers were randomly assigned to receive the facial recognition technology or usual care.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SSA
    Arm Type
    Experimental
    Arm Description
    Individuals with memory concerns in the experimental arm received the prototype facial recognition technology, which included a smartphone and smartwatch. The smartphone was equipped with facial recognition software application; the smartwatch communicated information with the smartphone. Persons with memory concerns and their family care partners were given a demonstration on how to utilize the technology.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Control participants did not receive the technology; at the conclusion of follow-up, all controls were offered the technology to use.
    Intervention Type
    Device
    Intervention Name(s)
    Social Support Aid
    Intervention Description
    Please see earlier; the social support aid technology consists of a smartphone with a facial recognition software application and a smartwatch. Up to 1,000 individuals can be enrolled in the facial recognition application. Enrollment includes typing individuals names and relationships of the person with memory concern into the application and taking pictures of PWMC's faces at multiple angles. Once enrolled and in view of the smartphone's camera, the SSA's application recognizes the individual's face and alerts the smartwatch. The watch then vibrates and displays the individuals' name and relationship to the PWMC.
    Primary Outcome Measure Information:
    Title
    Change in Dementia Quality of Life
    Description
    The 21-item modified Dementia Quality of Life instrument is a self-report survey that assesses various domains of quality of life in the person wtih dementia.
    Time Frame
    Baseline, 3-months, and 6-months
    Title
    Change in Cantril quality of life ladder
    Description
    The Cantril quality of life ladder is a single item survey that asks respondents to rate their overall quality of life on a scale of 0 (bottom of the latter) to 10 (top of the ladder).
    Time Frame
    Baseline, 3-months, and 6-months
    Secondary Outcome Measure Information:
    Title
    Pleasant events and activities of person with memory concerns
    Description
    The Pleasant Events and Activities-AD Schedule Short Form is a 17-item self-report survey that measures the degree of enjoyment persons with dementia have engaging in a range of activities.
    Time Frame
    3-months and 6-months
    Title
    Change in the frequency and quality of social interactions of persons with memory concerns
    Description
    Series of weekly, self-report calendar measures on types and quality of social interactions, developed for this study.
    Time Frame
    Baseline, 3-months, and 6-months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: PWMCs must be: A physician diagnosis of early-stage Alzheimer's disease, mild cognitive impairment, or a self-identified concern of memory loss. Able to complete surveys in English or Spanish SLUMS score of 20 or above Care partners of PWMCs must be: 21 years of age and over; self-identify 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''); indicate a willingness to use the SSA Exclusion Criteria: Indicates an unwillingness to use the SSA.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    31518270
    Citation
    McCarron HR, Zmora R, Gaugler JE. A Web-Based Mobile App With a Smartwatch to Support Social Engagement in Persons With Memory Loss: Pilot Randomized Controlled Trial. JMIR Aging. 2019 Jun 18;2(1):e13378. doi: 10.2196/13378.
    Results Reference
    result

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