Virtual Outreach and Individualized Coaching Extension

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorEmory University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Virtual Outreach and Individualized Coaching Extension

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: VOICEExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
Baseline, week 8, and week 12

Secondary outcomes

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

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
Baseline, week 8, and week 12

Other outcomes

Sponsors and contacts

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Emory University

Lead sponsor

American Nurses Foundation

Collaborator

This trial is not recruiting at the moment. You can still explore other options: