Voice Technology-Based Self-Management Intervention

NCT06982261 | Recruiting

• 1 other identifier: STUDY00009631
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Cognitive Impairment

Keywords

Low income older adults; Artificial Intelligence; Voice activated smart speakers (SS)

Outcome Measures

Primary Outcomes (7)

• Retention Rate

  Retention rate will be measured by the number of individuals who continue participating in a program for up 3 months

  3 months

• System Usability Scale

  Acceptance will be measured using the System Usability Scale (SUS) that is a widely used, validated tool for measuring the perceived usability of a system (e.g., software, website, device). It consists of 10 items, each rated on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). The researcher will modify the wording slightly to make the questions appropriate for the technology system being evaluated. Score \> 68: Above average usability Score = 68: Average usability benchmark Score \< 68: Below average usability

  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

  The PROMIS Item Bank v1.0 Self-Efficacy measure assesses self-reported current level of confidence in managing chronic conditions, with a focus on managing medications and treatment regimen related to chronic health conditions. It consists of 26 items, each rated on a 5-point Likert scale ranging from 1 (not at all confident) to 5 (very confident). Raw scores (sum of item responses) are converted to T-scores using the PROMIS scoring system. A score of 50 is the average for the United States general population, with a standard deviation of 10. Higher T-scores indicate greater self-efficacy in managing medications and treatment.

  Baseline, 2 months, and 3 months

• Self-Care of Chronic Illness Inventory (V.4C)

  The Self-Care of Chronic Illness Inventory (SC-CII) version 4c is a validated tool designed to assess self-care behaviors in individuals managing chronic illnesses. Each item within the SC-CII is rated on a 5-point Likert scale, typically ranging from 1 ("Never") to 5 ("Always"). It evaluates self-care across three key domains: Self-Care Maintenance (Section A), Self-Care Monitoring (Section B), and Self-Care Management (Section C). Also, it examines Self-Care Confidence (Section D). Scores for each domain are calculated by summing the item responses within that domain. Higher scores indicate better self-care behaviors in the respective domain. A standardized score of 70 or above in any domain is generally considered indicative of adequate self-care. Scores below 70 may suggest areas where the individual could benefit from additional support or intervention to enhance self-care practices.

  Baseline, 2 months, and 3 months

• Modified Computer Self-Efficacy Scale

  Modified Computer Self-Efficacy Scale (mCSES) is a modification of Compeau and Higgins 10-item Computer Self-Efficacy Scale, developed to make it applicable for clinical settings (for use with older people or people with disabilities using everyday technologies). The questions ask to indicate whether "you could use this unfamiliar technology under a variety of conditions". Rated on a 10-point scale of confidence. Principal components analysis yields a two-factor structure: 1. Using the Technology Alone (e.g., "If there was no one around to tell me what to do as I go"), and 2. Using the Technology with the Support of Others (e.g., " If someone else had helped me get started"). Participants with higher levels of technology self-efficacy would be more frequent users of everyday technology.

  Baseline, 2 months, and 3 months

• Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Adult Profile questionnaire

  The PROMIS-29 Adult Profile measure assesses pain intensity using a single 0-10 numeric pain rating item and seven health domains using four items each: physical functioning, fatigue, pain interference, depression, anxiety, ability to participate in social roles and activities, and sleep disturbance. Each item is rated on a Likert-type scale, typically 1 (not at all) to 5 (very much), with response options indicating the frequency or severity of symptoms or experiences. For most PROMIS instruments, a score of 50 is the average for the United States general population, with a standard deviation of 10. Higher scores for Depression, Fatigue, Sleep Disturbance, and Pain Interference indicate worse health than average.

  Baseline, 2 months, and 3 months

• Engagement in Self-Management Behaviors determined by smart speaker interaction logs

  The research team will extract the text-based Alexa usage data showing verbal commands used by each participant to examine types of verbal commands, frequency, and regularity of smart speaker use to determine participants' engagement in self-management behaviors.

  2 months and 3 months

Secondary Outcomes (1)

• Factors affecting the implementation and dissemination of the Voice2Manage

  2 months and 3 months

Study Arms (1)

Voice-activated smart speakers

EXPERIMENTAL

Participants will complete a set of standardized questionnaires. A list of smart speaker-based tasks will be introduced. Participants will then be asked to choose three tasks from a list.

Other: Voice-activated smart speakers

Interventions

Voice-activated smart speakers OTHER

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 device installation. The team will conduct weekly or bi-weekly check-in calls for two months, with additional home visits as needed. At two months, a home visit will include questionnaires and a 30-60 minute interview on intervention feasibility. Participants will then use the devices independently for one month, with a final home visit at three months for questionnaires and a closing interview.

Voice-activated smart speakers

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• University of California, Davis: collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30329, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jane Chung, PhD, RN

  Emory University - Nell Hodgson Woodruff School of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Chung, PhD, RN

CONTACT

404-544-9589; Jane.chung@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Acting Associate Professor

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: July 15, 2025
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available after publication.
• Access Criteria: Requests will be reviewed by the study's PI. Approved requesters will receive data through a secure data transfer platform following execution of a data use agreement.

Locations

US (1)