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Completed

NCT Number: NCT04700540

A Mobile Informatics Solution to Aid in Memory

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smartwatch Reminder (SR) system

Device

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 outcomes

  1. PWMC Loneliness

    Time frame: 3 months

    Original three-item measure, including:

    • How often do you feel you lack companionship?
    • How often do you feel left out?
    • How often do you feel isolated from others? Scale range 3-9, higher scores indicate higher rates of social isolation.

  2. PWMC Social Relationships and Social Support

    Time frame: 3 months

    The Lubben Social Network Scale (LSNS) is a measure of social relationships and social support networks. We used the shortened 6-item scale to reduce test burden. The 6-item scale has a range of 0 - 30 with higher scores indicating more robust social networks / access to support.

Secondary outcomes

  1. PWMC Physical and Mental Well-being

    Time frame: 3 months

    We used the Global Health Scale. This tool is designed to assess an individual's overall physical and mental wellbeing. The scale measures subjective health perceptions. Scale scores range from 0 - 100, with higher scores indicating higher rates of mental and physical well-being.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Advanced Medical Electronics
  • Brown University
  • University of Michigan

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 8, 2021
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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