Virtual Outreach and Individualized Coaching Extension

NCT07836114 | Not Yet Recruiting

• 1 other identifier: 2026P001819
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study tests whether a nurse-led program that uses a voice-controlled smart speaker in the home helps older adults better manage their chronic health conditions. It also examines which nursing staff and clinic resources would be needed to offer such a program in regular outpatient care.

Conditions

Mild Cognitive Impairment; Chronic Disease

Keywords

Artificial Intelligence; Personalized Voice Technology; Smart Speaker Devices

Outcome Measures

Primary Outcomes (3)

• Self-Care of Chronic Illness Inventory (V.4c) Section D: Self-Care Confidence Scale

  Researchers will use the Self-Care Confidence Scale to measure preliminary efficacy.

  Baseline, week 8, and week 12

• 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, week 8, and week 12

• Modified Computer Attitudes Scale - Confidence subscale

  Modified Computer Self-Efficacy Scale (mCSES) is a modification of the 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 respondents 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, week 8, and week 12

Secondary Outcomes (8)

• Geriatrics Depression Scale (GDS) - Short Form

  Baseline, week 8, and week 12

• Almere Model-Based Smart Speaker Acceptance Questionnaire

  Baseline, week 8, and week 12

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

  Baseline, week 8, and week 12

• Medical Outcomes Study Social Support Survey

  Baseline, week 8, and week 12

• University of California, Los Angeles (UCLA) Loneliness Scale (3 items)

  Baseline, week 8, and week 12

Study Arms (1)

VOICE

EXPERIMENTAL

Participants will receive an Echo Show smart speaker and a Fitbit Versa smartwatch for activity and sleep tracking, and receive a demonstration of the basic functions (e.g., "Alexa, what's the weather today?"; "Alexa, set a timer for 10 minutes"). Staff will assist with device setup using a team-generated account. Staff will review the task library (a curated list of smart speaker tasks for chronic disease self-management), considering the participant's health conditions and their digital literacy assessment, and will encourage the participant to choose their top three tasks. An initial selection will be recorded on the participant's copy of the task library.

Other: Virtual Outreach and Individualized Coaching Extension

Interventions

Virtual Outreach and Individualized Coaching Extension OTHER

VOICE (Virtual Outreach and Individualized Coaching Extension) is a nurse-led hybrid care program that combines in-home visits and telehealth coaching with personalized smart speakers and smartwatches, both integrated with a voice-based agent, to support chronic disease self-management among older adults with mild cognitive impairment (MCI). All study activities are procedures that supplement, and do not replace, the participant's usual clinical care; enrollment does not inform, modify, or change any participant's clinical care.

Also known as: VOICE

VOICE

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 years or older
• Two or more chronic conditions
• Mild cognitive impairment, defined as a Montreal Cognitive Assessment Blind (MoCA-Blind) score of 13 to 17, with no diagnosis of Alzheimer's disease or a related dementia
• Living independently in a community-based setting (not residing in a nursing home or in assisted living with skilled nursing support)
• Able to speak, read, and understand English
• Able to provide informed consent for themselves, as confirmed at the time of consent
• Home environment able to accommodate the study devices, including electrical power and a suitable location for an Echo Show
• Willing and able to engage in a technology-based intervention, as indicated by a Yes response to an engagement-readiness item administered during screening

You may not qualify if:

• Diagnosis of Alzheimer's disease or a related dementia
• Adults unable to consent for themselves
• Individuals who are not able to clearly understand English
• Severe uncorrected hearing or vision impairment that would prevent interaction with a voice-activated device with a screen
• Planned relocation or absence from the home for an extended period during the 12-week study period
• Concurrent enrollment in another intervention study addressing chronic disease self-management
• Any medical, psychiatric, or social circumstance that, in the judgment of the study team, would prevent safe participation or completion of study procedures

Sponsors & Collaborators

• Emory University: lead
• American Nurses Foundation: collaborator

Study Sites (1)

Metro Atlanta Area

Atlanta, Georgia, 30030, United States

Location

MeSH Terms

Conditions

Chronic Disease; Cognitive Dysfunction

Interventions

Voice

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

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: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Proposals may be submitted up to 36 months following article publication and should be directed to and approved by the Principal Investigator. Data requesters will need to sign a data use agreement to gain access to the data. Data will be shared via a secure file-sharing method.

Locations

US (1)