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Social Support Aid For People With Dementia

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status and phase

Completed
Phase 2

Conditions

Memory Loss
Dementia

Treatments

Device: Social Support Aid

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03645694
1502S63961
R44AG041667 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

All

Ages

21 to 100 years old

Volunteers

No 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

48 participants in 2 patient groups

SSA
Experimental group
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.
Treatment:
Device: Social Support Aid
Control
No Intervention group
Description:
Control participants did not receive the technology; at the conclusion of follow-up, all controls were offered the technology to use.

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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