NCT03645694

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

1.8 years

First QC Date

August 17, 2018

Last Update Submit

April 13, 2022

Conditions

Keywords

CaregivingTechnologySocial support

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline, 3-months, and 6-months

  • 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).

    Baseline, 3-months, and 6-months

Secondary Outcomes (2)

  • Pleasant events and activities of person with memory concerns

    3-months and 6-months

  • Change in the frequency and quality of social interactions of persons with memory concerns

    Baseline, 3-months, and 6-months

Study Arms (2)

SSA

EXPERIMENTAL

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.

Device: Social Support Aid

Control

NO INTERVENTION

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

Interventions

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.

SSA

Eligibility Criteria

Age21 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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

You may not qualify if:

  • Indicates an unwillingness to use the SSA.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DementiaMemory Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Individual with memory concerns and their family caregivers were randomly assigned to receive the facial recognition technology or usual care.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2018

First Posted

August 24, 2018

Study Start

November 1, 2016

Primary Completion

August 15, 2018

Study Completion

August 15, 2018

Last Updated

April 21, 2022

Record last verified: 2022-04