Mild Cognitive ImpairmentNCT06982261
Voice Technology-Based Self-Management Intervention
A study testing Voice-activated smart speakers in people with Mild Cognitive Impairment, run by Emory University at 1 site in United States.
Trial summary
This study aims to test a new technology-based program designed to help improve the ability to manage chronic conditions. This program includes daily smart speaker use for managing different tasks and technology learning. Proper self-management of chronic conditions is critical to the maintenance of health. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Voice-activated smart speakers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons 55 years of age and older,
- Living in subsidized housing or with a housing voucher and having an annual income less than $30K,
- One or more chronic conditions,
- Having probable mild cognitive impairment (MCI), based on the education-adjusted Montreal Cognitive Assessment (MoCA) score less than 24 and greater than or equal to 18,
- Living alone independently, and
- Able to speak and read English.
Who cannot join
- Severe visual/hearing impairment requiring assistance in participating in interactions with the smart speaker and integrated devices,
- Self-reported diagnoses of Alzheimer's disease and related dementias,
- Significant medical illness interfering with the study assessments and activities,
- Inability to provide informed consent, and
- Nursing home residents.
- Eligibility will not be limited to smart speaker ownership.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30329
About this study
Official title: Voice2Manage: Interactive Voice-Assisted Self-Management Intervention for Low-Income Older Adults
This study aims to test a new technology-based program designed to help improve the ability to manage chronic conditions.
This program includes daily smart speaker use for managing different tasks and technology learning.
Read more
Proper self-management of chronic conditions is critical to the maintenance of health. Digital technologies offer substantial potential to enhance self-management behaviors. Voice-operated smart speakers hold promise due to their ability to provide functional, cognitive, and social stimulation, send targeted reminders, and assist with daily schedules. Unfortunately, many older adults who live in low-income communities lack the resources and proficiency to take advantage of these options. Additionally, cognitive impairment is prevalent in independent living older adults, more prevalent in low-income older adults.
The goal is to address these critical challenges by identifying smart speaker-based functions preferred by older adults, exploring their technology challenges, introducing them to these functions, and providing necessary technology training to improve self-efficacy in managing chronic conditions and enhance their engagement in self-management behaviors.
Read the detailed description
Many older adults live with two or more chronic diseases. These conditions impact functional impairment and quality of life. Inadequate management of chronic conditions significantly burdens individuals and society, accounting for 75% to 90% of total healthcare expenditures in the United States. Proper self-management, the ability to manage symptoms, treatments, lifestyle changes, and psychosocial, cultural, and spiritual consequences of chronic conditions, is critical to effective chronic disease management. Central to this successful self-management is the concept of self-efficacy, a person's belief in their ability to accomplish specific tasks or particular goals. Digital technologies offer substantial potential to enhance self-management of chronic conditions. Unfortunately, many older adults living on a low income lack the resources and proficiency to take advantage of these options. Additionally, cognitive impairment is prevalent in independent-living older adults, which affects the ability to manage everyday health needs.
Voice-activated smart speakers (SS; e.g., Amazon Echo) especially hold promise due to their ability to provide functional, cognitive, and social stimulation, send targeted reminders, and assist with daily schedules. However, these devices and their applications are not always intuitive. Our preliminary studies demonstrated critical challenges in SS adoption and use in low-income older adults, such as difficulty setting up key SS functions or finding relevant resources or information necessary for figuring out the process. The challenges arose from various factors, including insufficient training and technical support, low health literacy, and cognitive impairments. Crucial to the successful use of SS to support low-income older adults, some initial development stages are necessary.
Researchers' overall objective in this research is to test the feasibility, acceptability, and preliminary efficacy of an interactive SS-based self-management intervention for low-income older adults living with chronic conditions and mild cognitive impairment. The study team will first identify SS functions preferred by this group of older adults and strategies to support their learning of SS-based functions for self-management of chronic conditions, and deploy them in older adults' homes to manage chronic conditions
- Conditions
- Mild Cognitive Impairment
- Being tested
- Voice-activated smart speakers
- Keywords
- Low income older adults, Artificial Intelligence, Voice activated smart speakers (SS)
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice-activated smart speakersOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Voice-activated smart speakers | Experimental | Participants will complete a set of standardized questionnaires. A list of smart speaker-based tasks will be introduced. Participants will then be asked to choose three tasks from a list. Receives: Other: Voice-activated smart speakers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention Rate
Retention rate will be measured by the number of individuals who continue participating in a program for up 3 months
Measured: 3 months
System Usability Scale
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
Measured: Baseline, 2 months, and 3 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment
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.
Measured: Baseline, 2 months, and 3 months
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.
Measured: Baseline, 2 months, and 3 months
Modified Computer Self-Efficacy Scale
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.
Measured: Baseline, 2 months, and 3 months
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.
Measured: Baseline, 2 months, and 3 months
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.
Measured: 2 months and 3 months
Secondary outcomes (1)
Factors affecting the implementation and dissemination of the Voice2Manage
Open ended questions to assess possible factors affecting implementation and dissemination. No scoring scale is available.
Measured: 2 months and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start15 Jul 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis
- Responsible party
- Principal investigator, Jane Chung, Emory University
- Investigators
- Jane Chung, PhD, RN, Principal investigator, Emory University - Nell Hodgson Woodruff School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982261
- Sponsor's protocol ID
- STUDY00009631
- Other IDs
- 2025P010196
- Status last verified
- Jul 2026
- First submitted
- 13 May 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be made available to qualified researchers.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice2Manage: Interactive Voice-Assisted Self-Management Intervention for Low-Income Older Adults
- ClinicalTrials.gov ID
- NCT06982261
- Acronym / sponsor ID
- STUDY00009631
- Conditions
- Mild Cognitive Impairment
- Keywords
- Low income older adults, Artificial Intelligence, Voice activated smart speakers (SS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- University of California, Davis
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to test a new technology-based program designed to help improve the ability to manage chronic conditions.
This program includes daily smart speaker use for managing different tasks and technology learning.
Proper self-management of chronic conditions is critical to the maintenance of health. Digital technologies offer substantial potential to enhance self-management behaviors. Voice-operated smart speakers hold promise due to their ability to provide functional, cognitive, and social stimulation, send targeted reminders, and assist with daily schedules. Unfortunately, many older adults who live in low-income communities lack the resources and proficiency to take advantage of these options. Additionally, cognitive impairment is prevalent in independent living older adults, more prevalent in low-income older adults.
The goal is to address these critical challenges by identifying smart speaker-based functions preferred by older adults, exploring their technology challenges, introducing them to these functions, and providing necessary technology training to improve self-efficacy in managing chronic conditions and enhance their engagement in self-management behaviors.
Detailed description
Many older adults live with two or more chronic diseases. These conditions impact functional impairment and quality of life. Inadequate management of chronic conditions significantly burdens individuals and society, accounting for 75% to 90% of total healthcare expenditures in the United States. Proper self-management, the ability to manage symptoms, treatments, lifestyle changes, and psychosocial, cultural, and spiritual consequences of chronic conditions, is critical to effective chronic disease management. Central to this successful self-management is the concept of self-efficacy, a person's belief in their ability to accomplish specific tasks or particular goals. Digital technologies offer substantial potential to enhance self-management of chronic conditions. Unfortunately, many older adults living on a low income lack the resources and proficiency to take advantage of these options. Additionally, cognitive impairment is prevalent in independent-living older adults, which affects the ability to manage everyday health needs.
Voice-activated smart speakers (SS; e.g., Amazon Echo) especially hold promise due to their ability to provide functional, cognitive, and social stimulation, send targeted reminders, and assist with daily schedules. However, these devices and their applications are not always intuitive. Our preliminary studies demonstrated critical challenges in SS adoption and use in low-income older adults, such as difficulty setting up key SS functions or finding relevant resources or information necessary for figuring out the process. The challenges arose from various factors, including insufficient training and technical support, low health literacy, and cognitive impairments. Crucial to the successful use of SS to support low-income older adults, some initial development stages are necessary.
Researchers' overall objective in this research is to test the feasibility, acceptability, and preliminary efficacy of an interactive SS-based self-management intervention for low-income older adults living with chronic conditions and mild cognitive impairment. The study team will first identify SS functions preferred by this group of older adults and strategies to support their learning of SS-based functions for self-management of chronic conditions, and deploy them in older adults' homes to manage chronic conditions
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Voice-activated smart speakers | Experimental | Other: Voice-activated smart speakersParticipants will complete a set of standardized questionnaires. A list of smart speaker-based tasks will be introduced. Participants will then be asked to choose three tasks from a list. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Persons 55 years of age and older,
- Living in subsidized housing or with a housing voucher and having an annual income less than $30K,
- One or more chronic conditions,
- Having probable mild cognitive impairment (MCI), based on the education-adjusted Montreal Cognitive Assessment (MoCA) score less than 24 and greater than or equal to 18,
- Living alone independently, and
Key exclusion criteria (6 listed)
- Severe visual/hearing impairment requiring assistance in participating in interactions with the smart speaker and integrated devices,
- Self-reported diagnoses of Alzheimer's disease and related dementias,
- Significant medical illness interfering with the study assessments and activities,
- Inability to provide informed consent, and
- Nursing home residents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voice-activated smart speakersParticipants 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. | Other | Voice-activated smart speakers |
Primary outcome
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.
1 secondary outcome
Factors affecting the implementation and dissemination of the Voice2Manage
Time frame: 2 months and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be made available to qualified researchers.
Related trials for Mild Cognitive Impairment
Recruiting
The Efficacy of an IADL-based Non-immersive Virtual Reality Training Program to Enhance ADL Performance and Cognitive Function for Persons at Risk of Dementia
Cognitive Enhancement, Subjective Cognitive Decline (SCD)
RecruitingPhase 2
Alzheimer's Tau Platform: Master Protocol
Preclinical Alzheimer's Disease, Alzheimer Disease
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Fuzhou Aging Brain Health Initiative
Dementia, Alzheimer Dementia (AD)
Recruiting
Choose Myself (Before) Losing Myself
Dementia (Diagnosis), Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jane Chung, PhD, RN principal investigator
Emory University - Nell Hodgson Woodruff School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voice-activated smart speakers in people with Mild Cognitive Impairment, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jane Chung, PhD, RN (404-544-9589, Jane.chung@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention Rate (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.