Voice Technology-Based Self-Management Intervention

OTHER

Voice-activated smart speakers

Participants will attend a single 90 to 120-minute in-person baseline visit to complete standardized questionnaires and review a list of smart speaker-based tasks. They will select three tasks; all will receive an Echo Show and a Fitbit Versa. Additional digital health devices (e.g., blood pressure monitor, in-home motion sensors) will be provided based on their selections. Participants will learn to interact with Alexa, followed by a second home visit one week later for task-specific setup and device installation. The team will conduct weekly or bi-weekly check-in calls for two months, with additional home visits as needed. At two months, a home visit will include questionnaires and a 30-60 minute interview on intervention feasibility. Participants will then use the devices independently for one month, with a final home visit at three months for questionnaires and a closing interview.

Retention Rate

Time frame: 3 months

Retention rate will be measured by the number of individuals who continue participating in a program for up 3 months

System Usability Scale

Time frame: Baseline, 2 months, and 3 months

Acceptance will be measured using the System Usability Scale (SUS) that is a widely used, validated tool for measuring the perceived usability of a system (e.g., software, website, device). It consists of 10 items, each rated on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). The researcher will modify the wording slightly to make the questions appropriate for the technology system being evaluated. Score \> 68: Above average usability Score = 68: Average usability benchmark Score \< 68: Below average usability

Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment

Time frame: Baseline, 2 months, and 3 months

The PROMIS Item Bank v1.0 Self-Efficacy measure assesses self-reported current level of confidence in managing chronic conditions, with a focus on managing medications and treatment regimen related to chronic health conditions. It consists of 26 items, each rated on a 5-point Likert scale ranging from 1 (not at all confident) to 5 (very confident). Raw scores (sum of item responses) are converted to T-scores using the PROMIS scoring system. A score of 50 is the average for the United States general population, with a standard deviation of 10. Higher T-scores indicate greater self-efficacy in managing medications and treatment.

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

Time frame: Baseline, 2 months, and 3 months

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 Self-Efficacy Scale

Time frame: Baseline, 2 months, and 3 months

Modified Computer Self-Efficacy Scale (mCSES) is a modification of 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 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.

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

Time frame: Baseline, 2 months, and 3 months

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.

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

Time frame: 2 months and 3 months

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.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.