NHRI Intelligent Voice Interactive Platform for High-Quality Community Living Among Older Adults

NCT07855874 | Recruiting DMC

• 1 other identifier: EC1130804
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Aging; Behavior

Keywords

quality of life; healthy aging; community-living elderly; smart voice interaction platform

Outcome Measures

Primary Outcomes (15)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline, 6 months

Secondary Outcomes (2)

• Technology Acceptance Model (TAM) Total Score (score)

  Baseline, 6 months

• System Usability Scale (SUS) (score)

  Baseline, 6 months

Other Outcomes (9)

• Digital Service Utilization (counts)

  Baseline, 6 months

• Perceived Informal Social Support Composite Score (score)

  Baseline, 6 months

• Educational Attainment Level (category)

  Baseline, 6 months

Study Arms (1)

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.

Behavioral: NHRI Smart Voice Interaction Platform

Interventions

NHRI Smart Voice Interaction Platform BEHAVIORAL

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: 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.

NHRI Smart Voice Interaction Platform

Eligibility Criteria

• Age: 55 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Individuals diagnosed with dementia who do not own or have access to a smartphone.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead

Study Sites (1)

Jiuzhuang Community Development Association

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Behavior

Central Study Contacts

Chueh-Ho Lin, Dr.

CONTACT

+886 (05)620-4000; chueh.ho@nhri.edu.tw

Pin-Chun Wang

CONTACT

+886 937195691; pcwang@nhri.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: October 2, 2026
• Study Start: August 21, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)