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Recruiting NCT06982261

Voice Technology-Based Self-Management Intervention

No phase Interventional Mild Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Voice-activated smart speakers.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment. Basic parameters: from 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Voice2Manage: Interactive Voice-Assisted Self-Management Intervention for Low-Income Older Adults

Overview

This study aims to test a new technology-based program designed to help improve the ability to manage chronic conditions. This program includes daily smart speaker use for managing different tasks and technology learning. Proper self-management of chronic conditions is critical to the maintenance of health. Digital technologies offer substantial potential to enhance self-management behaviors. Voice-operated smart speakers hold promise due to their ability to provide functional, cognitive, and social stimulation, send targeted reminders, and assist with daily schedules. Unfortunately, many older adults who live in low-income communities lack the resources and proficiency to take advantage of these options. Additionally, cognitive impairment is prevalent in independent living older adults, more prevalent in low-income older adults. The goal is to address these critical challenges by identifying smart speaker-based functions preferred by older adults, exploring their technology challenges, introducing them to these functions, and providing necessary technology training to improve self-efficacy in managing chronic conditions and enhance their engagement in self-management behaviors.

Detailed description

Many older adults live with two or more chronic diseases. These conditions impact functional impairment and quality of life. Inadequate management of chronic conditions significantly burdens individuals and society, accounting for 75% to 90% of total healthcare expenditures in the United States. Proper self-management, the ability to manage symptoms, treatments, lifestyle changes, and psychosocial, cultural, and spiritual consequences of chronic conditions, is critical to effective chronic disease management. Central to this successful self-management is the concept of self-efficacy, a person's belief in their ability to accomplish specific tasks or particular goals. Digital technologies offer substantial potential to enhance self-management of chronic conditions. Unfortunately, many older adults living on a low income lack the resources and proficiency to take advantage of these options. Additionally, cognitive impairment is prevalent in independent-living older adults, which affects the ability to manage everyday health needs.

Voice-activated smart speakers (SS; e.g., Amazon Echo) especially hold promise due to their ability to provide functional, cognitive, and social stimulation, send targeted reminders, and assist with daily schedules. However, these devices and their applications are not always intuitive. Our preliminary studies demonstrated critical challenges in SS adoption and use in low-income older adults, such as difficulty setting up key SS functions or finding relevant resources or information necessary for figuring out the process. The challenges arose from various factors, including insufficient training and technical support, low health literacy, and cognitive impairments. Crucial to the successful use of SS to support low-income older adults, some initial development stages are necessary.

Researchers' overall objective in this research is to test the feasibility, acceptability, and preliminary efficacy of an interactive SS-based self-management intervention for low-income older adults living with chronic conditions and mild cognitive impairment. The study team will first identify SS functions preferred by this group of older adults and strategies to support their learning of SS-based functions for self-management of chronic conditions, and deploy them in older adults' homes to manage chronic conditions

Interventions

  • Other Voice-activated smart speakers
    Participants will attend a single 90 to 120-minute in-person baseline visit to complete standardized questionnaires and review a list of smart speaker-based tasks. They will select three tasks; all will receive an Echo Show and a Fitbit Versa. Additional digital health devices (e.g., blood pressure monitor, in-home motion sensors) will be provided based on their selections. Participants will learn to interact with Alexa, followed by a second home visit one week later for task-specific setup and

Primary outcome measures

  • Retention Rate [Time frame: 3 months]
  • System Usability Scale [Time frame: Baseline, 2 months, and 3 months]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment [Time frame: Baseline, 2 months, and 3 months]
  • Self-Care of Chronic Illness Inventory (V.4C) [Time frame: Baseline, 2 months, and 3 months]
  • Modified Computer Self-Efficacy Scale [Time frame: Baseline, 2 months, and 3 months]
  • Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Adult Profile questionnaire [Time frame: Baseline, 2 months, and 3 months]
  • Engagement in Self-Management Behaviors determined by smart speaker interaction logs [Time frame: 2 months and 3 months]
Secondary outcome measures (1)
  • Factors affecting the implementation and dissemination of the Voice2Manage [Time frame: 2 months and 3 months]

Eligibility criteria

Inclusion criteria

  • Persons 55 years of age and older,
  • Living in subsidized housing or with a housing voucher and having an annual income less than $30K,
  • One or more chronic conditions,
  • Having probable mild cognitive impairment (MCI), based on the education-adjusted Montreal Cognitive Assessment (MoCA) score less than 24 and greater than or equal to 18,
  • Living alone independently, and
  • Able to speak and read English.

Exclusion criteria

  • Severe visual/hearing impairment requiring assistance in participating in interactions with the smart speaker and integrated devices,
  • Self-reported diagnoses of Alzheimer's disease and related dementias,
  • Significant medical illness interfering with the study assessments and activities,
  • Inability to provide informed consent, and
  • Nursing home residents.
  • Eligibility will not be limited to smart speaker ownership.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Emory University — Atlanta

Identifiers

NCT: NCT06982261 · STUDY00009631 · 2025P010196

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗