AgingNCT07855874
NHRI Intelligent Voice Interactive Platform for High-Quality Community Living Among Older Adults
A study testing NHRI Smart Voice Interaction Platform in people with Aging and Behavior, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to evaluate the impact of an integrated smart voice platform on quality of life and local healthy aging among community-dwelling older adults in both urban and rural areas. Read more about this study
- Who is it for?
- Ages 55 to 100 yearsHealthy volunteers can take part
- What is being tested?
- NHRI Smart Voice Interaction Platform
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Aug 2025to 31 Dec 2027
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cognitively intact older adults, or those with mild cognitive impairment (MCI).
- Able to independently use a smartphone and engage in voice-based interactive question-and-answer sessions.
Who cannot join
- Individuals diagnosed with dementia who do not own or have access to a smartphone.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Jiuzhuang Community Development Association
Taipei
Li-Shi Lee, +886 931518686, e0800633688@gmail.com
About this study
Official title: Utilizing Smart Technology to Build High-Quality Elderly Community Living - Constructing a Cross-Domain Resource Integration Platform for Communities
The goal of this clinical trial is to evaluate the impact of an integrated smart voice platform on quality of life and local healthy aging among community-dwelling older adults in both urban and rural areas. The main questions it aims to answer are:
Does the smart voice platform, integrating healthcare, long-term care, and health promotion resources, improve the community life quality of elderly participants?
Read more
Participants will:
Receive access to and training on an existing smart voice platform system that connects healthcare, long-term care, and local cross-domain resources (businesses, NPOs, and NGOs).
Complete assessments evaluating their quality of life, digital capability, and healthy aging outcomes.
- Being tested
- NHRI Smart Voice Interaction Platform
- Keywords
- quality of life, healthy aging, community-living elderly, smart voice interaction platform
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NHRI Smart Voice Interaction PlatformBehavioural
The NHRI- Smart Voice Interaction Platform is an AI-driven, voice-interactive behavioral care platform customized for older adults to address health information-seeking barriers and enhance self-management. It features five core components:
- Interactive Voice Consultation: Natural-language voice Q\&A providing reliable health guidance (chronic diseases, nutrition, pain care, mental wellbeing) and anti-fraud counseling.
- Bimodal Digital Newsletters: Health and wellness bulletins accessible via on-screen reading or on-demand spoken audio read-aloud.
- Self-Monitoring: Digital tracking for uploading physiological metrics (blood pressure, blood glucose) to foster daily self-care.
- Community Resource Navigation: Directory enabling users to search for nearby medical services, long-term care, and living essentials.
- Technical Support: Routine assistance by the NHRI team to maintain digital engagement.
| Study group | Role | What they receive |
|---|---|---|
| NHRI Smart Voice Interaction Platform | Experimental | Community-dwelling older adults in this single-arm interventional study use the NHRI-SmartCare intelligent voice platform at participating community senior centers, indigenous cultural health stations, or local housing communities over a 6-month intervention period. Following onboarding and training, participants engage in routine voice interactions for health and anti-fraud inquiries, read or listen to audio-read digital health newsletters, upload physiological metrics for self-health management, navigate nearby daily living and long-term care resources, and receive ongoing technical support from the NHRI research team. Comprehensive health-related quality of life, intrinsic capacity, cognitive, social participation, physical fitness, and platform usability assessments are administered at baseline and at 6-month follow-up. Receives: Behavioral: NHRI Smart Voice Interaction Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36 Health Survey (SF-36 v1) Subscale Scores (score)
Health-related quality of life is assessed using the SF-36 Taiwan Version, evaluating 8 subscales: Physical Functioning (PF, 10 items, raw 10-30), Role-Physical (RP, 4 items, raw 4-8), Bodily Pain (BP, 2 items, raw 2-12), General Health (GH, 5 items, raw 5-25), Vitality (VT, 4 items, raw 4-24), Social Functioning (SF, 2 items, raw 2-10), Role-Emotional (RE, 3 items, raw 3-6), and Mental Health (MH, 5 items, raw 5-30). Per standard Taiwanese scoring guidelines, raw scores are linearly transformed into an identical 0 to 100 standardized scale: [(raw score - min score) / score range] * 100. The outcome reports changes in each standardized subscale score (Unit of Measure: points, range 0-100), where higher scores indicate superior functional health. Changes from baseline to 6 months are evaluated.
Measured: Baseline, 6 months
Health-Promoting Lifestyle Profile II (HPLP-II) Total Score (score)
Self-care and daily health practices are assessed using the Health-Promoting Lifestyle Profile II (HPLP-II, Chinese version). The instrument evaluates 52 items across six dimensions: health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management, each rated on a 4-point Likert scale (1 = "never" to 4 = "routinely"). The outcome is reported as the overall mean composite score across all items (Unit of Measure: score on a scale of 1.0 to 4.0), where higher scores indicate more frequent adoption of health-promoting self-management behaviors. Changes from baseline to 6 months are evaluated.
Measured: Baseline, 6 months
30-Second Arm Curl Test (counts)
Upper-body muscular strength and endurance are assessed using the 30-Second Arm Curl Test from the Senior Fitness Test protocol. Participants sit upright and complete as many biceps curls as possible within 30 seconds using their dominant hand (5-pound dumbbell for females, 8-pound for males). The outcome is reported as the total count of correctly completed repetitions (Unit of Measure: repetitions). For clinical interpretation, repetition counts are categorized against sex- and age-specific normative tiers (Excellent, Good, Average, Below Average, Poor). Higher counts indicate superior functional muscle strength. Changes from baseline to 6 months are evaluated.
Measured: Baseline, 6 months
4-Meter Walk Test Functional Mobility (category)
Mobility and gait function are assessed using the 4-Meter Walk Test adapted from the Short Physical Performance Battery (SPPB) protocol. Participants walk a 4-meter course at their usual, comfortable pace. Walk performance is converted into a 4-point ordinal category reflecting functional mobility tiers: 3 = <3.5 seconds (fast gait speed, superior mobility), 2 = 3.5-4.9 seconds, 1 = 5.0-8.0 seconds, and 0 = >8.0 seconds (slow gait speed, mobility impairment). The outcome is reported as the change in this single ordinal category score (Unit of Measure: category on a scale of 0 to 3), where higher scores indicate superior functional mobility. Changes from baseline to 6 months are evaluated.
Measured: Baseline, 6 months
30-Second Chair Stand Test (counts)
Lower-extremity functional strength and dynamic balance are measured by recording the maximum number of full stands completed from a straight-backed chair within 30 seconds, with arms folded across the chest. The outcome is reported as the total count of completed stands (Unit of Measure: stands). A higher number indicates superior lower-body muscular strength, endurance, and functional mobility. Changes from baseline to 6 months are evaluated.
Measured: Baseline, 6 months
Mini Nutritional Assessment (MNA) (score)
Nutritional status is evaluated using the full 18-item Mini Nutritional Assessment (MNA). Assessment follows a validated two-step procedure: Step 1 Screening (items A-F, max 14 points: 12-14 indicates normal nutritional status; 8-11 indicates risk of malnutrition; 0-7 indicates malnutrition). Participants scoring <=11 points proceed to Step 2 Assessment (items G-R, max 16 points) to derive the full Malnutrition Indicator Score (sum of screening and assessment, max 30 points). The outcome is reported as the continuous total MNA score (Unit of Measure: points, range 0.0 to 30.0), classified as: 24.0-30.0 (normal status), 17.0-23.5 (at risk of malnutrition), and <17.0 (malnourished). Higher scores indicate better nutritional status. Changes from baseline to 6 months are evaluated.
Measured: Baseline, 6 months
UCLA Loneliness Scale (Version 3) Total Score (score)
Subjective feelings of loneliness and social isolation are assessed using the 20-item UCLA Loneliness Scale (Version 3). Items are rated on a 4-point Likert scale from 1 ("never") to 4 ("often"). The outcome is reported as the total sum across all items (Unit of Measure: points, range 20 to 80), categorized as: 20-34 (low degree of loneliness), 35-49 (moderate degree of loneliness), 50-64 (moderately high degree of loneliness), and 65-80 (high degree of loneliness). Lower scores reflect reduced feelings of loneliness and stronger social connectedness. Changes from baseline to 6 months are evaluated.
Measured: Baseline, 6 months
Perceived Stress Scale (PSS-14) Total Score (score)
Perceived psychological stress over the past month is measured using the 14-item Perceived Stress Scale (PSS-14). Positively stated items (4, 5, 6, 7, 9, 10, 13) are reverse-scored from 4 ("never") to 0 ("very often"), while remaining items (1, 2, 3, 8, 11, 12, 14) are scored from 0 ("never") to 4 ("very often"). The outcome is reported as the total composite score (Unit of Measure: points, range 0 to 56), categorized as: 0-28 (normal), 29-42 (elevated stress), and 43-56 (severe stress requiring assistance). Higher scores indicate greater perceived psychological stress. Changes from baseline to 6 months are evaluated.
Measured: Baseline, 6 months
Geriatric Depression Scale (GDS-15) Total Score (score)
Depressive symptoms over the past week are evaluated using the 15-item Geriatric Depression Scale (GDS-15) in a dichotomous format (Yes/No). Positively worded items (1, 5, 7, 11, 13) are scored 1 point for "No" and 0 for "Yes", while depressive items (2, 3, 4, 6, 8, 9, 10, 12, 14, 15) are scored 1 point for "Yes" and 0 for "No". The outcome is reported as the single continuous total score (Unit of Measure: points, range 0 to 15), categorized as: 0-6 (well-adapted, normal status), 7-10 (moderate emotional distress), and 11-15 (severe emotional distress recommending psychiatric referral). Lower scores reflect fewer depressive symptoms and superior affective wellbeing. Changes from baseline to 6 months are evaluated.
Measured: Baseline, 6 months
Brain Health Test (BHT) Total Score (score)
Global cognitive screening is evaluated using the TDS Brain Health Test (BHT), assessing four domains: Orientation (4 points), Word Registration (5 points), Category Verbal Fluency (animal naming within 60 seconds: >=9 words = 2 points, 5-8 words = 1 point, <5 words = 0 points), and Word Recall (5 points). The outcome is reported as the total composite screening score (Unit of Measure: points, range 0 to 16), where scores <=9 indicate suspected mild dementia or cognitive impairment, and scores >=10 reflect normal cognitive function. Higher scores represent superior global cognitive performance. Changes from baseline to 6 months are evaluated.
Measured: Baseline, 6 months
WHO Integrated Care for Older People (ICOPE): Number of Impaired Domains (domains)
Intrinsic capacity is assessed using the World Health Organization Integrated Care for Older People (WHO ICOPE) screening tool, covering six domains: cognitive decline, limited mobility, malnutrition, visual impairment, hearing loss, and depressive symptoms. The outcome is reported as the total count of abnormal/impaired domains (Unit of Measure: domains, range 0 to 6). A lower count indicates better-preserved intrinsic capacity and overall functional health. Changes from baseline to 6 months are evaluated.
Measured: Baseline, 6 months
Montreal Cognitive Assessment (MoCA) Total Score (score)
Global cognitive performance is measured using the Taiwan Version of the Montreal Cognitive Assessment (MoCA). It assesses 7 domains: visuospatial/executive, naming, attention, language, abstraction, delayed recall, and orientation. The outcome is reported as the continuous total score, adjusted for education (1 extra point added for <=12 years of education; Unit of Measure: points, range 0 to 30). A score >=26 denotes normal cognition. Higher scores represent superior cognitive function. Changes from baseline to 6 months are evaluated.
Measured: Baseline, 6 months
Participation Measure-3 Domains, 4 Dimensions (PM-3D4D): Diversity Score (ratio)
Activity diversity is evaluated using the 24-item PM-3D4D across Social (6 items), Community (12 items), and Productivity (6 items) domains. Participants indicate whether they performed each activity during the past 3 months (dichotomous: 0 = No, 1 = Yes). The outcome is reported as the overall Diversity Score, defined as the proportion of engaged activities (number of affirmative responses divided by 24 total items; Unit of Measure: ratio, range 0.00 to 1.00). Higher ratios indicate greater activity variety. Changes from baseline to 6 months are evaluated.
Measured: Baseline, 6 months
Participation Measure-3 Domains, 4 Dimensions (PM-3D4D): Frequency Score (score)
Activity participation frequency over the past 3 months is assessed using the 24-item PM-3D4D across Social (6 items, rated 0-6), Community (12 items, rated 0-6), and Productivity (6 items, rated 0-4) domains. Consistent with the original scoring manual metrics, the outcome evaluates changes in domain-specific summated frequency scores: Social domain (Unit of Measure: points, range 0 to 36), Community domain (Unit of Measure: points, range 0 to 72), and Productivity domain (Unit of Measure: points, range 0 to 24). Higher scores reflect more frequent social, community, and productive participation. Changes from baseline to 6 months are evaluated.
Measured: baseline, 6 months
Participation Measure-3 Domains, 4 Dimensions (PM-3D4D): Difficulty Score (score)
Participation difficulty is assessed using the Traditional Chinese PM-3D4D (24 items across Social [6 items], Community [12 items], and Productivity [6 items] domains). For each performed activity over the past 3 months, perceived difficulty is rated on a 4-point scale (1 = "Very difficult" to 4 = "Not difficult at all"). Raw subscale difficulty scores are converted into standardized 0 to 100 scores via Rasch-based conversion tables and averaged across domains to yield a composite Total Difficulty Score (Unit of Measure: score on a scale of 0 to 100). Higher scores reflect greater ease and less difficulty in participation. Changes from baseline to 6 months are evaluated.
Measured: Baseline, 6 months
Secondary outcomes (2)
Technology Acceptance Model (TAM) Total Score (score)
Participants' acceptance of the smart voice platform is evaluated using an adapted 11-item Technology Acceptance Model (TAM) questionnaire. Each item is scored on a 7-point Likert scale ranging from 1 ("strongly disagree") to 7 ("strongly agree"). The outcome is reported as the total sum score across all 11 items (Unit of Measure: points, range 11 to 77), evaluating perceived usefulness, perceived ease of use, and behavioral intention to use the platform. Higher scores represent greater technology acceptance. Changes from baseline to 6 months are evaluated.
Measured: Baseline, 6 months
System Usability Scale (SUS) (score)
Platform usability and user satisfaction are evaluated using the 10-item System Usability Scale (SUS). Each item is rated on a 5-point Likert scale (1 = "strongly disagree" to 5 = "strongly agree"). Raw item scores are converted according to the standard Brooke scoring algorithm into a composite score from 0 to 100 (Unit of Measure: points, range 0 to 100). Higher scores indicate superior platform usability (scores >=68 represent acceptable usability). Changes from baseline to 6 months are evaluated.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start21 Aug 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855874
- Sponsor's protocol ID
- EC1130804
- Status last verified
- May 2026
- First submitted
- 17 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared beyond the study team in order to protect participant confidentiality and per the institutional review board approval guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Smart Technology to Build High-Quality Elderly Community Living - Constructing a Cross-Domain Resource Integration Platform for Communities
- ClinicalTrials.gov ID
- NCT07855874
- Acronym / sponsor ID
- EC1130804
- Keywords
- quality of life, healthy aging, community-living elderly, smart voice interaction platform
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Oct 2026 (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.
The goal of this clinical trial is to evaluate the impact of an integrated smart voice platform on quality of life and local healthy aging among community-dwelling older adults in both urban and rural areas. The main questions it aims to answer are:
Does the smart voice platform, integrating healthcare, long-term care, and health promotion resources, improve the community life quality of elderly participants?
Participants will:
Receive access to and training on an existing smart voice platform system that connects healthcare, long-term care, and local cross-domain resources (businesses, NPOs, and NGOs).
Complete assessments evaluating their quality of life, digital capability, and healthy aging outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NHRI Smart Voice Interaction Platform | Experimental | Behavioral: NHRI Smart Voice Interaction PlatformCommunity-dwelling older adults in this single-arm interventional study use the NHRI-SmartCare intelligent voice platform at participating community senior centers, indigenous cultural health stations, or local housing communities over a 6-month intervention period. Following onboarding and training, participants engage in routine voice interactions for health and anti-fraud inquiries, read or listen to audio-read digital health newsletters, upload physiological metrics for self-health management, navigate nearby daily living and long-term care resources, and receive ongoing technical support from the NHRI research team. Comprehensive health-related quality of life, intrinsic capacity, cognitive, social participation, physical fitness, and platform usability assessments are administered at baseline and at 6-month follow-up. |
Who may qualify
- Ages
- 55 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cognitively intact older adults, or those with mild cognitive impairment (MCI).
- Able to independently use a smartphone and engage in voice-based interactive question-and-answer sessions.
Key exclusion criteria (1 listed)
- Individuals diagnosed with dementia who do not own or have access to a smartphone.
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 |
|---|---|---|
| NHRI Smart Voice Interaction PlatformThe NHRI- Smart Voice Interaction Platform is an AI-driven, voice-interactive behavioral care platform customized for older adults to address health information-seeking barriers and enhance self-management. It features five core components: 1. Interactive Voice Consultation: Natural-language voice Q\&A providing reliable health guidance (chronic diseases, nutrition, pain care, mental wellbeing) and anti-fraud counseling. 2. Bimodal Digital Newsletters: Health and wellness bulletins accessible via on-screen reading or on-demand spoken audio read-aloud. 3. Self-Monitoring: Digital tracking for uploading physiological metrics (blood pressure, blood glucose) to foster daily self-care. 4. Community Resource Navigation: Directory enabling users to search for nearby medical services, long-term care, and living essentials. 5. Technical Support: Routine assistance by the NHRI team to maintain digital engagement. | Behavioural | NHRI Smart Voice Interaction Platform |
Primary outcome
SF-36 Health Survey (SF-36 v1) Subscale Scores (score)
Time frame: Baseline, 6 months
Health-related quality of life is assessed using the SF-36 Taiwan Version, evaluating 8 subscales: Physical Functioning (PF, 10 items, raw 10-30), Role-Physical (RP, 4 items, raw 4-8), Bodily Pain (BP, 2 items, raw 2-12), General Health (GH, 5 items, raw 5-25), Vitality (VT, 4 items, raw 4-24), Social Functioning (SF, 2 items, raw 2-10), Role-Emotional (RE, 3 items, raw 3-6), and Mental Health (MH, 5 items, raw 5-30). Per standard Taiwanese scoring guidelines, raw scores are linearly transformed into an identical 0 to 100 standardized scale: [(raw score - min score) / score range] * 100. The outcome reports changes in each standardized subscale score (Unit of Measure: points, range 0-100), where higher scores indicate superior functional health. Changes from baseline to 6 months are evaluated.
Health-Promoting Lifestyle Profile II (HPLP-II) Total Score (score)
Time frame: Baseline, 6 months
Self-care and daily health practices are assessed using the Health-Promoting Lifestyle Profile II (HPLP-II, Chinese version). The instrument evaluates 52 items across six dimensions: health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management, each rated on a 4-point Likert scale (1 = "never" to 4 = "routinely"). The outcome is reported as the overall mean composite score across all items (Unit of Measure: score on a scale of 1.0 to 4.0), where higher scores indicate more frequent adoption of health-promoting self-management behaviors. Changes from baseline to 6 months are evaluated.
30-Second Arm Curl Test (counts)
Time frame: Baseline, 6 months
Upper-body muscular strength and endurance are assessed using the 30-Second Arm Curl Test from the Senior Fitness Test protocol. Participants sit upright and complete as many biceps curls as possible within 30 seconds using their dominant hand (5-pound dumbbell for females, 8-pound for males). The outcome is reported as the total count of correctly completed repetitions (Unit of Measure: repetitions). For clinical interpretation, repetition counts are categorized against sex- and age-specific normative tiers (Excellent, Good, Average, Below Average, Poor). Higher counts indicate superior functional muscle strength. Changes from baseline to 6 months are evaluated.
4-Meter Walk Test Functional Mobility (category)
Time frame: Baseline, 6 months
Mobility and gait function are assessed using the 4-Meter Walk Test adapted from the Short Physical Performance Battery (SPPB) protocol. Participants walk a 4-meter course at their usual, comfortable pace. Walk performance is converted into a 4-point ordinal category reflecting functional mobility tiers: 3 = <3.5 seconds (fast gait speed, superior mobility), 2 = 3.5-4.9 seconds, 1 = 5.0-8.0 seconds, and 0 = >8.0 seconds (slow gait speed, mobility impairment). The outcome is reported as the change in this single ordinal category score (Unit of Measure: category on a scale of 0 to 3), where higher scores indicate superior functional mobility. Changes from baseline to 6 months are evaluated.
30-Second Chair Stand Test (counts)
Time frame: Baseline, 6 months
Lower-extremity functional strength and dynamic balance are measured by recording the maximum number of full stands completed from a straight-backed chair within 30 seconds, with arms folded across the chest. The outcome is reported as the total count of completed stands (Unit of Measure: stands). A higher number indicates superior lower-body muscular strength, endurance, and functional mobility. Changes from baseline to 6 months are evaluated.
Mini Nutritional Assessment (MNA) (score)
Time frame: Baseline, 6 months
Nutritional status is evaluated using the full 18-item Mini Nutritional Assessment (MNA). Assessment follows a validated two-step procedure: Step 1 Screening (items A-F, max 14 points: 12-14 indicates normal nutritional status; 8-11 indicates risk of malnutrition; 0-7 indicates malnutrition). Participants scoring <=11 points proceed to Step 2 Assessment (items G-R, max 16 points) to derive the full Malnutrition Indicator Score (sum of screening and assessment, max 30 points). The outcome is reported as the continuous total MNA score (Unit of Measure: points, range 0.0 to 30.0), classified as: 24.0-30.0 (normal status), 17.0-23.5 (at risk of malnutrition), and <17.0 (malnourished). Higher scores indicate better nutritional status. Changes from baseline to 6 months are evaluated.
UCLA Loneliness Scale (Version 3) Total Score (score)
Time frame: Baseline, 6 months
Subjective feelings of loneliness and social isolation are assessed using the 20-item UCLA Loneliness Scale (Version 3). Items are rated on a 4-point Likert scale from 1 ("never") to 4 ("often"). The outcome is reported as the total sum across all items (Unit of Measure: points, range 20 to 80), categorized as: 20-34 (low degree of loneliness), 35-49 (moderate degree of loneliness), 50-64 (moderately high degree of loneliness), and 65-80 (high degree of loneliness). Lower scores reflect reduced feelings of loneliness and stronger social connectedness. Changes from baseline to 6 months are evaluated.
Perceived Stress Scale (PSS-14) Total Score (score)
Time frame: Baseline, 6 months
Perceived psychological stress over the past month is measured using the 14-item Perceived Stress Scale (PSS-14). Positively stated items (4, 5, 6, 7, 9, 10, 13) are reverse-scored from 4 ("never") to 0 ("very often"), while remaining items (1, 2, 3, 8, 11, 12, 14) are scored from 0 ("never") to 4 ("very often"). The outcome is reported as the total composite score (Unit of Measure: points, range 0 to 56), categorized as: 0-28 (normal), 29-42 (elevated stress), and 43-56 (severe stress requiring assistance). Higher scores indicate greater perceived psychological stress. Changes from baseline to 6 months are evaluated.
Geriatric Depression Scale (GDS-15) Total Score (score)
Time frame: Baseline, 6 months
Depressive symptoms over the past week are evaluated using the 15-item Geriatric Depression Scale (GDS-15) in a dichotomous format (Yes/No). Positively worded items (1, 5, 7, 11, 13) are scored 1 point for "No" and 0 for "Yes", while depressive items (2, 3, 4, 6, 8, 9, 10, 12, 14, 15) are scored 1 point for "Yes" and 0 for "No". The outcome is reported as the single continuous total score (Unit of Measure: points, range 0 to 15), categorized as: 0-6 (well-adapted, normal status), 7-10 (moderate emotional distress), and 11-15 (severe emotional distress recommending psychiatric referral). Lower scores reflect fewer depressive symptoms and superior affective wellbeing. Changes from baseline to 6 months are evaluated.
Brain Health Test (BHT) Total Score (score)
Time frame: Baseline, 6 months
Global cognitive screening is evaluated using the TDS Brain Health Test (BHT), assessing four domains: Orientation (4 points), Word Registration (5 points), Category Verbal Fluency (animal naming within 60 seconds: >=9 words = 2 points, 5-8 words = 1 point, <5 words = 0 points), and Word Recall (5 points). The outcome is reported as the total composite screening score (Unit of Measure: points, range 0 to 16), where scores <=9 indicate suspected mild dementia or cognitive impairment, and scores >=10 reflect normal cognitive function. Higher scores represent superior global cognitive performance. Changes from baseline to 6 months are evaluated.
WHO Integrated Care for Older People (ICOPE): Number of Impaired Domains (domains)
Time frame: Baseline, 6 months
Intrinsic capacity is assessed using the World Health Organization Integrated Care for Older People (WHO ICOPE) screening tool, covering six domains: cognitive decline, limited mobility, malnutrition, visual impairment, hearing loss, and depressive symptoms. The outcome is reported as the total count of abnormal/impaired domains (Unit of Measure: domains, range 0 to 6). A lower count indicates better-preserved intrinsic capacity and overall functional health. Changes from baseline to 6 months are evaluated.
Montreal Cognitive Assessment (MoCA) Total Score (score)
Time frame: Baseline, 6 months
Global cognitive performance is measured using the Taiwan Version of the Montreal Cognitive Assessment (MoCA). It assesses 7 domains: visuospatial/executive, naming, attention, language, abstraction, delayed recall, and orientation. The outcome is reported as the continuous total score, adjusted for education (1 extra point added for <=12 years of education; Unit of Measure: points, range 0 to 30). A score >=26 denotes normal cognition. Higher scores represent superior cognitive function. Changes from baseline to 6 months are evaluated.
Participation Measure-3 Domains, 4 Dimensions (PM-3D4D): Diversity Score (ratio)
Time frame: Baseline, 6 months
Activity diversity is evaluated using the 24-item PM-3D4D across Social (6 items), Community (12 items), and Productivity (6 items) domains. Participants indicate whether they performed each activity during the past 3 months (dichotomous: 0 = No, 1 = Yes). The outcome is reported as the overall Diversity Score, defined as the proportion of engaged activities (number of affirmative responses divided by 24 total items; Unit of Measure: ratio, range 0.00 to 1.00). Higher ratios indicate greater activity variety. Changes from baseline to 6 months are evaluated.
Participation Measure-3 Domains, 4 Dimensions (PM-3D4D): Frequency Score (score)
Time frame: baseline, 6 months
Activity participation frequency over the past 3 months is assessed using the 24-item PM-3D4D across Social (6 items, rated 0-6), Community (12 items, rated 0-6), and Productivity (6 items, rated 0-4) domains. Consistent with the original scoring manual metrics, the outcome evaluates changes in domain-specific summated frequency scores: Social domain (Unit of Measure: points, range 0 to 36), Community domain (Unit of Measure: points, range 0 to 72), and Productivity domain (Unit of Measure: points, range 0 to 24). Higher scores reflect more frequent social, community, and productive participation. Changes from baseline to 6 months are evaluated.
Participation Measure-3 Domains, 4 Dimensions (PM-3D4D): Difficulty Score (score)
Time frame: Baseline, 6 months
Participation difficulty is assessed using the Traditional Chinese PM-3D4D (24 items across Social [6 items], Community [12 items], and Productivity [6 items] domains). For each performed activity over the past 3 months, perceived difficulty is rated on a 4-point scale (1 = "Very difficult" to 4 = "Not difficult at all"). Raw subscale difficulty scores are converted into standardized 0 to 100 scores via Rasch-based conversion tables and averaged across domains to yield a composite Total Difficulty Score (Unit of Measure: score on a scale of 0 to 100). Higher scores reflect greater ease and less difficulty in participation. Changes from baseline to 6 months are evaluated.
2 secondary outcomes
Technology Acceptance Model (TAM) Total Score (score)
Time frame: Baseline, 6 months
System Usability Scale (SUS) (score)
Time frame: Baseline, 6 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 2 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared beyond the study team in order to protect participant confidentiality and per the institutional review board approval guidelines.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NHRI Smart Voice Interaction Platform in people with Aging and Behavior, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
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 2 inclusion and 1 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 2 Oct 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 Taiwan. 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 Chueh-Ho Lin, Dr. (+886 (05)620-4000 ext. 51142, chueh.ho@nhri.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF-36 Health Survey (SF-36 v1) Subscale Scores (score) (time frame: Baseline, 6 months). The study lists 15 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 2 Oct 2026.