The Effectiveness of AIFIGA Program on Nursing Home Nursing Staff and Family and Residents'Health

February 5, 2026 updated by: Chang Gung Memorial Hospital

The Effectiveness of Artificial Intelligence Family Involvement Generative Agent (AIFIGA) Program on Nursing Home Nursing Staff and Family and Residents'Health

This study aims to develop and evaluate the longitudinal effectiveness of the Artificial Intelligence Family Involvement Generative Agent (AIFIGA) program in enhancing the health of nursing staff, family, and residents' health through the use of a sequential, mixed methods research design. The development of a real-time, interactive, and informative AIFIGA program that sparks innovation is necessary to achieve effective communication between families and nursing staff.

In Phase I, lasting 18 months, we will develop the AIFIGA program based on triangulate research design, observation and in-depth interview understanding the daily communication experiences and expectations from both families and nursing staff perception in Nursing Homes(NHs) after COVID-19, as well as our previous years' research results. The training data for AIFIGA will be derived from the collection of communication dialogues in these qualitative data. Furthermore, the intelligence of AIFIGA will be developed using publicly available large language models (LLMs).

In Phase II, spanning the next 18 months, we will evaluate the longitudinal effects of the AIFIGA program on the health of residents, families, and nursing staff, tracking changes over time (baseline, 1 month, 3 months, and 6 months). There will be two groups of participants: (a) an AIFIGA group that receives the AIFIGA program and uses it for 3 months, and (b) a control group that receives only routine care.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Hsinchu, Taiwan
        • Recruiting
        • Catholic Mercy Hospital Attached Nursing Home
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

All resident-caregiver pairs meeting the inclusion criteria will be invited to join the study.

  1. residents aged ≥ 60 years, resident's family were aged equal or higher than 20 years.
  2. both residents and family can communicate in Mandarin or Taiwanese
  3. residents have a Mini-Mental State Examination (MMSE) score equal to or higher than 16 for residents with no formal education or higher than 24 for residents with at least a primary school education
  4. both residents and family agree to participate
  5. the family is a significant member of the resident, such as a caregiver.

For nurses and nursing aides:

  1. working in the selected nursing home who agree to participate in our program.
  2. aged equal or higher than 20 years.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AIFIGA group
receives the AIFIGA program and uses it for 3 months
Behavioral: AIFIGA program
receives the Artificial Intelligence Family Involvement Generative Agent (AIFIGA) program and uses it for 3 months
No Intervention: control group
receives only routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
resident health-Geriatric Depression Scale (GDS)
Time Frame: baseline, 1 month, 3 months and 6 months
scale for depression( scored from 0 through to 15.Scores of 0-4 are considered normal; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.)
baseline, 1 month, 3 months and 6 months
resident health-Activity of daily living (ADL)
Time Frame: baseline, 1 month, 3 months and 6 months
assess individual's ability to perform basic self-care tasks (scored from 0 through to 100. higher scores mean more independence)
baseline, 1 month, 3 months and 6 months
social support scale
Time Frame: baseline
Evaluated quantities of social support (four-point Likert scale, where higher scores indicate a greater amount of each type of social resource) & satisfaction with social support (five-point Likert scale, where higher scores indicate greater satisfaction with social support)
baseline
brief Center for Epidemiological Studies Depression Scale(CESD-10)
Time Frame: baseline, 1 month, 3 months and 6 months
assessment for family' depressive status.(scored from 0 through to 30. Any score equal to or above 10 is considered depressed)
baseline, 1 month, 3 months and 6 months
The General Health Questionnaire-12(GHQ-12)
Time Frame: baseline, 1 month, 3 months and 6 months
assessing the mental health status of respondents. ( total score ranges from 0 to 36, Higher scores mean better mental health status outcome)
baseline, 1 month, 3 months and 6 months
Family Meaning of Nursing-Home Visits scale
Time Frame: baseline, 1 month, 3 months and 6 months
measurement of family visiting involvement meaning
baseline, 1 month, 3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Study Chair: Hsiu Hsin Tsai, PhD, Chang Gung University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

August 25, 2024

First Submitted That Met QC Criteria

August 25, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 202400678B0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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