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Chronic DiseaseVOICENCT07836114

Virtual Outreach and Individualized Coaching Extension

A study testing Virtual Outreach and Individualized Coaching Extension in people with Chronic Disease and Mild Cognitive Impairment, run by Emory University at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Chronic Disease, Mild Cognitive Impairment
What is being tested?
Virtual Outreach and Individualized Coaching Extension
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
Oct 2026to Feb 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jane Chung, PhD, RN contact

404-544-9589

Jane.chung@emory.edu

United States1 site

  • Metro Atlanta Area

    Atlanta, Georgia, 30030

    Jane Chung, PhD, RN

Other trials in United States

About this study

Official title: VOICE (Virtual Outreach and Individualized Coaching Extension): A Nurse-Led Hybrid Care Program Using Personalized Voice Technology for Older Adults With Chronic Conditions and Mild Cognitive Impairment

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.

Read the detailed description

The VOICE is a project designed to help older adults manage their health using an Echo Show, a smartwatch, and support from a nurse. These tools could help patients keep track of health goals and build healthy habits.

The Research Team will conduct a smart speaker-based semi-individualized intervention to support older adults' management of chronic conditions. Registered nurse research staff, paired with undergraduate- or graduate-level students (preferably those in nursing), will conduct an initial home visit to assess treatment plans, cognitive abilities, living situation, and motivation, then apply clinical judgment to match smart speaker tasks to individual patient needs and provide digital training required for participants' learning of smart speaker devices.

Participants will be expected to use the Echo Show and smartwatch regularly throughout the study. Participants will complete at least 3 health-related activities each day, such as setting medication reminders, monitoring sleep, or completing other activities they choose with the study team.

Being tested
Virtual Outreach and Individualized Coaching Extension
Keywords
Artificial Intelligence, Personalized Voice Technology, Smart Speaker Devices
Medical subject headings
Chronic Disease, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Outreach and Individualized Coaching ExtensionOther

    Also called VOICE

    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.

Study groups in NCT07836114
Study groupRoleWhat they receive
VOICEExperimentalParticipants 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.
Receives: Other: Virtual Outreach and Individualized Coaching Extension

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, week 8, and week 12

  2. 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.

    Measured: Baseline, week 8, and week 12

  3. 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.

    Measured: Baseline, week 8, and week 12

Secondary outcomes (8)

  1. Geriatrics Depression Scale (GDS) - Short Form

    The Geriatric Depression Scale (GDS) short form uses a 15-item yes/no questionnaire where one point is given for each answer indicating depressive symptoms, with a total score of 5 or more suggesting depression.

    0 to 4 points: Normal (depression not likely). 5 to 8 points (or > 5): Suggests mild depression; warrants a comprehensive medical or mental health assessment.

    9 to 11 points (or ≥ 10): Moderate depression; almost always indicates clinical depression.

    12 to 15 points: Severe depression

    Measured: Baseline, week 8, and week 12

  2. Almere Model-Based Smart Speaker Acceptance Questionnaire

    The Almere Model is a prominent framework used to evaluate how older adults accept assistive social agents and conversational devices. When adapting the Almere Model for a Smart Speaker acceptance research study, the questionnaire is typically structured around 11-12 core constructs measured on a 5-pointLikert scale (from Totally Disagree to Totally Agree).

    A higher score (4.0 - 5.0) generally indicates a strong, positive disposition toward that specific aspect of the smart speaker. A lower score (1.0 - 2.0) signals a barrier to entry or a negative perception.

    Measured: Baseline, week 8, and week 12

  3. 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.

    Measured: Baseline, week 8, and week 12

  4. Medical Outcomes Study Social Support Survey

    The Medical Outcomes Study Social Support Survey is a 19-item, self-administered questionnaire designed to measure the availability of functional social support for patients with chronic conditions. The survey evaluates four specific domains of social support: Emotional/Informational Support: Having someone to confide in, give advice, or offer empathetic understanding. Tangible (Instrumental) Support: Receiving material or behavioral assistance, such as help with daily chores if you are sick. Affectionate Support: Experiencing expressions of love and affection. Positive Social Interaction: Having someone available to do fun things or pass the time with. Items are typically rated on a 5-point Likert scale (ranging from "none of the time" to "all of the time"). It produces four distinct subscale scores plus an overall functional social support index. Scores are often transformed to a 0-100 range, where higher scores mean greater available support.

    Measured: Baseline, week 8, and week 12

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

    The UCLA 3-Item Loneliness Scale consists of three questions assessing how often a person feels lacking companionship, left out, or isolated from others. Each item is rated on a 3-point scale:1 = Hardly ever; 2 = Some of the time; 3 = Often, yielding a total score ranging from 3 to 9, where scores from 3 to 5 indicate low or no loneliness, and scores from 6 to 9 indicate significant or high loneliness

    Measured: Baseline, week 8, and week 12

  6. Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function - Abilities Subset - Short Form 8a

    The PROMIS Cognitive Function - Abilities Subset - Short Form 8a is a self-reported tool designed to evaluate a patient's perceived cognitive strengths over the past 7 days. The Abilities Subset features positively worded items focusing on capabilities like mental sharpness, memory, concentration, and thinking speed. Scoring involves calculating a total raw score and then converting it to a standardized T-score. The form consists of 8 items, each rated on a 5-point Likert scale ranging from 1 (Never) to 5 (Always). Scores can range from 8 to 40. PROMIS measures are standardized so that the scale mean is 50 with a standard deviation (SD) of 10.

    In clinical practice, scores are typically categorized based on standard deviations from the norm:

    T-score ≥ 45: Within normal limits / average cognitive abilities. T-score < 45: Indicates potential cognitive impairment or noticeable cognitive decline compared to the general population.

    Measured: Baseline, week 8, and week 12

  7. Participants' self-report of smart speaker task completions by using Alexa skill

    Tool developed by the team

    Measured: Daily (after intervention started) throughout study participation up to 12 weeks

  8. 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.

    Measured: Daily (after intervention started) throughout study participation up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionFeb 2028 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07836114
Sponsor's protocol ID
2026P001819
Acronym
VOICE
Status last verified
Sep 2026
First submitted
17 Sep 2026
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data that underlie the results reported in publications will be available to qualified researchers.

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Outreach and Individualized Coaching Extension in people with Chronic Disease and Mild Cognitive Impairment, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jane Chung, PhD, RN (404-544-9589, Jane.chung@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-Care of Chronic Illness Inventory (V.4c) Section D: Self-Care Confidence Scale (time frame: Baseline, week 8, and week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07836114.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026; AzTrials last refreshed its copy on 29 Oct 2026.

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