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NCT Number: NCT07836114

Virtual Outreach and Individualized Coaching Extension

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Metro Atlanta Area

Atlanta, Georgia, 30030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: VOICE

Primary outcomes

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

    Time frame: Baseline, week 8, and week 12

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

  2. Self-Care of Chronic Illness Inventory (V.4c)

    Time frame: Baseline, week 8, and week 12

    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.

  3. Modified Computer Attitudes Scale - Confidence subscale

    Time frame: Baseline, week 8, and week 12

    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.

Secondary outcomes

  1. Geriatrics Depression Scale (GDS) - Short Form

    Time frame: Baseline, week 8, and week 12

    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

  2. Almere Model-Based Smart Speaker Acceptance Questionnaire

    Time frame: Baseline, week 8, and week 12

    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.

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

    Time frame: Baseline, week 8, and week 12

    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.

  4. Medical Outcomes Study Social Support Survey

    Time frame: Baseline, week 8, and week 12

    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.

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

    Time frame: Baseline, week 8, and week 12

    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

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

    Time frame: Baseline, week 8, and week 12

    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.

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

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

    Tool developed by the team

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

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

    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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • American Nurses Foundation

Registry information

Official study 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

Acronym: VOICE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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