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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Self-Care of Chronic Illness Inventory (V.4c) Section D: Self-Care Confidence Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
VOICE
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.
干预措施: Virtual Outreach and Individualized Coaching Extension (Other)
结局指标
主要结局
Self-Care of Chronic Illness Inventory (V.4c) Section D: Self-Care Confidence Scale
时间窗: Baseline, week 8, and week 12
Researchers will use the Self-Care Confidence Scale to measure preliminary efficacy.
Self-Care of Chronic Illness Inventory (V.4c)
时间窗: 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.
Modified Computer Attitudes Scale - Confidence subscale
时间窗: 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.
次要结局
- 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)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function - Abilities Subset - Short Form 8a(Baseline, week 8, and week 12)
- Participants' self-report of smart speaker task completions by using Alexa skill(Daily (after intervention started) throughout study participation up to 12 weeks)
- Engagement in Self-Management Behaviors determined by smart speaker interaction logs(Daily (after intervention started) throughout study participation up to 12 weeks)
研究者
Jane Chung
Associate Professor
Emory University