Social Support Aid For People With Dementia

Dementia Clinical Trial

Official title:

Social Support Aid For People With Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03645694
• Other study ID #: 1502S63961
• Secondary ID: R44AG041667
• Status: Completed
• Phase: Phase 2
• Start date: November 1, 2016
• Est. completion date: August 15, 2018

Study information

• Verified date: April 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 15, 2018
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Memory Disorders
• Memory Loss

Intervention

Device:
• Social Support Aid
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Minnesota	Advanced Medical Electronics, National Institute on Aging (NIA)

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	3-months and 6-months
Secondary	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.	Baseline, 3-months, and 6-months