Smart Nursing AI Agent for Health Self-Management

NCT07761663 | Not Yet Recruiting

• 1 other identifier: TVGH_CG26018B
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop and evaluate a smart nursing AI agent to support health self-management among middle-aged and older patients, and further to examine its effectiveness in home care and health self-management. The goal is to propose innovative strategies for middle-aged and older care that enhance the quality of home care and strengthen patients' health self-management abilities. A randomized controlled trial design will be adopted, with a planned enrollment of 102 participants. Participants will be randomly assigned to either the experimental group or the control group. Regardless of group assignment, their routine medical care will remain unchanged. Both groups will participate in the study for 12 weeks (8 weeks of intervention and 4 weeks of follow-up), with identical frequency and number of follow-ups, interviews, and evaluations. The experimental group will receive an 8 week intervention using the smart nursing AI agent care model, which provides daily interaction, reminder systems, personalized recommendations, activity monitoring, goal setting, motivational support, and health self-management education. The control group will continue with the existing standard health education approach. Data collection will include demographic information, medical history, physiological indicators, functional activity measures (e.g., steps, distance, exercise duration), sarcopenia screening, nutritional assessment, physical activity levels, health self-management ability, health literacy, quality of life, and digital usage behaviors. Statistical analyses will be conducted to evaluate the effectiveness, feasibility, and acceptability of the intervention.

Conditions

Mobility Limitations; Community-dwelling Older Adults; Middle-aged and Older Adults

Keywords

Health Self-Management; Smart Nursing AI Agent; eHealth Literacy; community-dwelling older adults; Middle-aged and older adults; mobility limitations

Outcome Measures

Primary Outcomes (10)

• Change from baseline in Sarcopenia (SARC-F) questionnaire score at 3 months

  The SARC-F questionnaire is a rapid, 5-question clinical screening tool. The tool evaluates five key components of functional decline (Strength, Assistance with walking, Rise from a chair, Climb stairs, Falls). For each question, patients score between 0 (None) and 2 (A lot or unable or ≧ 4 falls) depending on the severity of their limitation.

  Baseline and 3 months

• Change from baseline in Mini Nutritional Assessment (MNA) score at 3 months

  The Mini Nutritional Assessment (MNA) is a validated, 6-question screening tool used to quickly identify adults aged 65 and older who are malnourished or at risk of malnutrition.The tool uses a scoring system with a maximum of 14 points. The score determines the individual's nutritional category:12 to 14 points is normal nutritional status, 8 to 11 points is risk of malnutrition, and 0 to 7 points is malnourished.

  Baseline and 3 months

• Change from baseline in International Physical Activity Questionnaire-Short Form (IPAQ-SF) score (MET-minutes/week) at 3 months

  The International Physical Activity Questionnaire-Short Form (IPAQ-SF) is a widely used, 7-item survey designed to measure health-related physical activity and sedentary behavior. It evaluates time spent walking, as well as moderate and vigorous-intensity activities over the last 7 days. The score is expressed as metabolic equivalent tasks (MET)-minutes per week, calculated by multiplying the MET level of an activity (walking, moderate, or vigorous) by its duration and frequency. Higher MET-minutes/week values indicate higher levels of physical activity.

  Baseline and 3 months

• Change from baseline in daily step count at 1 and 2 months

  This measure assesses the physical activity level of participants based on the average number of daily steps. Data are automatically tracked and collected via the platform's backend system using the designated JoiiCare mobile application.

  Baseline, 1 and 2 Months

• Change from baseline in Partners in Health (PIH) scale score at 1 and 2 months

  The PIH scale has demonstrated potential to be a reliable and valid measure of chronic condition self-management. It comprises 12 items, with response options ranging from 0 (very little or never) to 8 (always or very well), and a total score ranging from 0 to 96 points. Higher scores indicate better self-management ability / a higher level of self-management.

  Baseline, 1 and 2 Months

• Change from baseline in eHealth Literacy Scale (eHEALS) score at 1 and 2 months

  The eHEALS is an 8-item measure of eHealth literacy designed to assess consumers' combined knowledge, comfort, and perceived skills in finding, evaluating, and applying electronic health information to health problems. It comprises 8 items, with response options ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). The total score ranges from 8 to 40 points. Higher scores indicate a higher level of perceived eHealth literacy.

  Baseline, 1 and 2 Months

• Change from baseline in EQ-5D index score at 1 and 2 months

  The EuroQol 5-Dimension (EQ-5D) index score assesses health-related quality of life across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The health states are converted into a single index score using a standard country-specific value set. The score typically ranges from less than 0 (where 0 represents death and 1 represents perfect health), with higher scores indicating a better health state.

  Baseline, 1 and 2 Months

• Change from baseline in daily walking distance (meters) at 1 and 2 months

  This measure evaluates the average physical distance covered by participants per day. Data are automatically tracked and retrieved from the platform's backend database via the JoiiCare mobile application.

  Baseline, 1 and 2 Months

• Change from baseline in daily exercise duration (minutes) at 1 and 2 months

  This measure records the average amount of time (in minutes) participants spend engaging in exercise daily. Data are captured and compiled through the platform's backend system based on the JoiiCare mobile application activity logs.

  Baseline, 1 and 2 Months

• Change from baseline in EQ Visual Analog Scale (EQ-VAS) score at 1 and 2 months

  The EQ Visual Analog Scale (EQ-VAS) records the participant's self-rated health on a vertical visual analog scale. The score ranges from 0 to 100, where 0 represents the worst health you can imagine, and 100 represents the best health you can imagine.

  Baseline, 1 and 2 Months

Secondary Outcomes (4)

• Change from baseline in digital platform stickiness (average daily app usage time) at 1 and 2 months

  Baseline, 1 and 2 Months

• User satisfaction was assessed two months after the experimental group was administered

  2 months

• Change from baseline in health education completion rate (percentage) at 1 and 2 months

  Baseline, 1 and 2 Months

• Change from baseline in task adherence rate (percentage) at 1 and 2 months

  Baseline, 1 and 2 Months

Study Arms (2)

Smart nursing AI agent group

EXPERIMENTAL

The experimental group will receive an 8-week intervention using the smart nursing AI agent, which provides daily interaction, reminder systems, personalized recommendations, activity monitoring, goal setting, motivational support, and health self-management education

Behavioral: Smart Nursing AI Agent

Existing standard group

NO INTERVENTION

The control group will continue with the existing standard health education approach.

Interventions

Smart Nursing AI Agent BEHAVIORAL

Smart Nursing AI Agent which provides daily interaction, reminder systems, personalized recommendations, activity monitoring, goal setting, motivational support, and health self-management education.

Smart nursing AI agent group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 50 years or older who present with mobility limitations such as gait instability, sarcopenia, joint degeneration, chronic pain, or functional decline
• Able to ambulate
• Alert and oriented

You may not qualify if:

• Terminal cancer or major illness with a prognosis of left 6 months
• Moderate to severe dementia or language expression disorders
• Individuals with significant audiovisual impairments that prevent AI conversation
• Unable to complete walking tests on their own

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead
• Taichung Veterans General Hospital: collaborator

Study Sites (1)

National Yang Ming Chiao Tung University Nursing Building Room 504A Taipei, Nursing Building, No.155, Sec.2, Li-Nong Street,, Taiwan, 112

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Heng-Hsin Tung, PhD, RN

  National Yang Ming Chiao Tung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheng Ting CHIH, PhD

CONTACT

+886-972701990; chengting.ns14@nycu.edu.tw

Heng-Hsin Tung, PhD, RN

CONTACT

+886-2-28267000; henghsin@nycu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: control group and experimental group

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 12, 2026
• Study Start: August 5, 2026
• Primary Completion (Estimated): August 5, 2027
• Study Completion (Estimated): August 5, 2028
• Last Updated: August 12, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)