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N/A N=156 Randomized Single-blind Supportive Care

A Mobile Informatics Solution to Aid in Memory

Alzheimer Disease · Dementia

Enrolled (actual)
156
Serious AEs
1.9%
Results posted
Mar 2025
Primary outcome: Primary: PWMC Loneliness — 4.90; 5.28 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Smartwatch Reminder (SR) system (Device)
Age
Adult, Older Adult · 21+ yrs
Sex
All
Sponsor
University of Minnesota
Primary completion
Apr 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
PWMC Loneliness
4.90; 5.28
PRIMARY
PWMC Social Relationships and Social Support
13.50; 10.72
SECONDARY
PWMC Physical and Mental Well-being
32.69; 32.72

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04700540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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