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

Not Applicable

Recruiting

• Conditions: Family; Nursing Home; Digital Health
• Interventions: Behavioral: AIFIGA program

• Registration Number: NCT06574438
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-08-25
• Study First Submitted QC: 2024-08-25
• Study First Posted: 2024-08-28
• Study Start: 2024-09-24
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-16
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AIFIGA group	AIFIGA program	receives the AIFIGA program and uses it for 3 months

Primary Outcome Measures

Name	Time	Method
brief Center for Epidemiological Studies Depression Scale(CESD-10)	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)
Family Meaning of Nursing-Home Visits scale	baseline, 1 month, 3 months and 6 months	measurement of family visiting involvement meaning
social support scale	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)
resident health-Geriatric Depression Scale (GDS)	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.)
resident health-Activity of daily living (ADL)	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)
The General Health Questionnaire-12(GHQ-12)	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)

Trial Locations

Locations (1)

Catholic Mercy Hospital Attached Nursing Home; 🇨🇳 Hsinchu, Taiwan