NCT06574438

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress58%
Sep 2024Jul 2027

First Submitted

Initial submission to the registry

August 25, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

September 24, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

February 9, 2026

Status Verified

June 1, 2025

Enrollment Period

2.8 years

First QC Date

August 25, 2024

Last Update Submit

February 5, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • resident health-Geriatric Depression Scale (GDS)

    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)

    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

    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)

    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)

    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

    measurement of family visiting involvement meaning

    baseline, 1 month, 3 months and 6 months

Study Arms (2)

AIFIGA group

EXPERIMENTAL

receives the AIFIGA program and uses it for 3 months

Behavioral: AIFIGA program

control group

NO INTERVENTION

receives only routine care

Interventions

AIFIGA programBEHAVIORAL

receives the Artificial Intelligence Family Involvement Generative Agent (AIFIGA) program and uses it for 3 months

AIFIGA group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • residents aged ≥ 60 years, resident's family were aged equal or higher than 20 years.
  • both residents and family can communicate in Mandarin or Taiwanese
  • 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
  • both residents and family agree to participate
  • the family is a significant member of the resident, such as a caregiver.
  • For nurses and nursing aides:
  • working in the selected nursing home who agree to participate in our program.
  • aged equal or higher than 20 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic Mercy Hospital Attached Nursing Home

Hsinchu, Taiwan

RECRUITING

Study Officials

  • Hsiu Hsin Tsai, PhD

    Chang Gung University

    STUDY CHAIR

Central Study Contacts

Hsiu Hsin Tsai, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2024

First Posted

August 28, 2024

Study Start

September 24, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

February 9, 2026

Record last verified: 2025-06

Locations