Clinical trial NCT03645694: Social Support Aid For People With Dementia
Official title: Social Support Aid For People With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dementia
Memory Loss
Keywords: Caregiving
Technology
Social support
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Advanced Medical Electronics
name: National Institute on Aging (NIA)
First posted: 2018-08-24
Enrollment: 48
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individual with memory concerns and their family caregivers were randomly assigned to receive the facial recognition technology or usual care.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Dementia Quality of Life
timeFrame: Baseline, 3-months, and 6-months
measure: Change in Cantril quality of life ladder
timeFrame: Baseline, 3-months, and 6-months
Secondary outcomes:
measure: Pleasant events and activities of person with memory concerns
timeFrame: 3-months and 6-months
measure: Change in the frequency and quality of social interactions of persons with memory concerns
timeFrame: Baseline, 3-months, and 6-months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.