An interventional study of Virtual Outreach and Individualized Coaching Extension in Chronic Disease and Mild Cognitive Impairment, sponsored by Emory University. Not yet recruiting at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Emory University · Not applicable, Interventional, and Supportive care
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.
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.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 50 is below the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.
Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
Compared within Cognitive Dysfunction, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Chronic Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, week 8, and week 12
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
Time frame: Baseline, week 8, and week 12
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.
Time frame: Baseline, week 8, and week 12
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.
Time frame: Baseline, week 8, and week 12
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.
Time frame: Baseline, week 8, and week 12
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
Time frame: Baseline, week 8, and week 12
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.
Time frame: Baseline, week 8, and week 12
Participants' self-report of smart speaker task completions by using Alexa skill
Tool developed by the team
Time frame: Daily (after intervention started) throughout study participation up to 12 weeks
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.
Time frame: Daily (after intervention started) throughout study participation up to 12 weeks
Plan to share: Yes — De-identified individual participant data that underlie the results reported in publications will be available to qualified researchers.
Supporting information: 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.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Feb 2028, 16 months later.
Of 1,442 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's planned 16 months is below that.
Counting every sponsor, half of 1,511 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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