[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657225":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":52,"studyPopulation":45,"armGroups":53,"interventions":60,"overallOfficials":66,"centralContacts":71,"locations":76,"responsibleParty":92,"collaborators":95,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":62,"officialTitle":102,"acronym":55,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":105,"minAge":106,"maxAge":45,"enrollmentInfo":107,"targetDuration":45,"studyType":110,"phases":111,"briefSummary":112,"conditions":113,"keywords":116,"overallStatus":120,"whyStopped":45,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Emory University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":45},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"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",{"measure":14,"description":15,"timeFrame":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).\n\nScores 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.",{"measure":17,"description":18,"timeFrame":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.",[20,23,26,29,32,35,38,42],{"measure":21,"description":22,"timeFrame":12},"Geriatrics Depression Scale (GDS) - Short Form","The Geriatric Depression Scale (GDS) short form uses a 15-item yes\u002Fno questionnaire where one point is given for each answer indicating depressive symptoms, with a total score of 5 or more suggesting depression.\n\n0 to 4 points: Normal (depression not likely). 5 to 8 points (or \\> 5): Suggests mild depression; warrants a comprehensive medical or mental health assessment.\n\n9 to 11 points (or ≥ 10): Moderate depression; almost always indicates clinical depression.\n\n12 to 15 points: Severe depression",{"measure":24,"description":25,"timeFrame":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).\n\nA 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.",{"measure":27,"description":28,"timeFrame":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.",{"measure":30,"description":31,"timeFrame":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\u002FInformational 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.",{"measure":33,"description":34,"timeFrame":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",{"measure":36,"description":37,"timeFrame":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.\n\nIn clinical practice, scores are typically categorized based on standard deviations from the norm:\n\nT-score ≥ 45: Within normal limits \u002F average cognitive abilities. T-score \\\u003C 45: Indicates potential cognitive impairment or noticeable cognitive decline compared to the general population.",{"measure":39,"description":40,"timeFrame":41},"Participants' self-report of smart speaker task completions by using Alexa skill","Tool developed by the team","Daily (after intervention started) throughout study participation up to 12 weeks",{"measure":43,"description":44,"timeFrame":41},"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.",null,{"allocation":47,"interventionModel":48,"interventionModelDescription":45,"primaryPurpose":49,"observationalModel":45,"timePerspective":45,"maskingInfo":50},"NA","SINGLE_GROUP","SUPPORTIVE_CARE",{"masking":51,"maskingDescription":45,"whoMasked":45},"NONE","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.\n\nThe 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.\n\nParticipants 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.",[54],{"label":55,"type":56,"description":57,"interventionNames":58},"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.",[59],"Other: Virtual Outreach and Individualized Coaching Extension",[61],{"type":6,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"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).\n\nAll 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.",[55],[55],[67],{"name":68,"affiliation":69,"role":70},"Jane Chung, PhD, RN","Emory University - Nell Hodgson Woodruff School of Nursing","PRINCIPAL_INVESTIGATOR",[72],{"name":68,"role":73,"phone":74,"phoneExt":45,"email":75},"CONTACT","404-544-9589","Jane.chung@emory.edu",[77],{"facility":78,"status":45,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"Metro Atlanta Area","Atlanta","Georgia","30030","United States","US",{"type":85,"coordinates":86},"Point",[87,88],-84.38798,33.749,{"lat":88,"lon":87},[91],{"name":68,"role":73,"phone":45,"phoneExt":45,"email":45},{"type":70,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"Jane Chung","Associate Professor",[96],{"name":97,"class":6},"American Nurses Foundation","100657225","virtual-outreach-and-individualized-coaching-extension-100657225",false,"NCT07836114","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","Inclusion Criteria:\n\n* Age 65 years or older\n* Two or more chronic conditions\n* 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\n* Living independently in a community-based setting (not residing in a nursing home or in assisted living with skilled nursing support)\n* Able to speak, read, and understand English\n* Able to provide informed consent for themselves, as confirmed at the time of consent\n* Home environment able to accommodate the study devices, including electrical power and a suitable location for an Echo Show\n* Willing and able to engage in a technology-based intervention, as indicated by a Yes response to an engagement-readiness item administered during screening\n\nExclusion Criteria:\n\n* Diagnosis of Alzheimer's disease or a related dementia\n* Adults unable to consent for themselves\n* Individuals who are not able to clearly understand English\n* Severe uncorrected hearing or vision impairment that would prevent interaction with a voice-activated device with a screen\n* Planned relocation or absence from the home for an extended period during the 12-week study period\n* Concurrent enrollment in another intervention study addressing chronic disease self-management\n* Any medical, psychiatric, or social circumstance that, in the judgment of the study team, would prevent safe participation or completion of study procedures",true,"ALL","65 Years",{"count":108,"type":109},50,"ESTIMATED","INTERVENTIONAL",[47],"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.",[114,115],"Chronic Disease","Mild Cognitive Impairment",[117,118,119],"Artificial Intelligence","Personalized Voice Technology","Smart Speaker Devices","NOT_YET_RECRUITING","2026-09-17",{"date":123,"type":124},"2026-09-23","ACTUAL",{"date":126,"type":109},"2026-10",{"date":128,"type":109},"2028-02",{"name":5,"class":6},1]