Clinical trial NCT06574438: The Effectiveness of AIFIGA Program on Nursing Home Nursing Staff and Family and Residents'health
Official title: The Effectiveness of Artificial Intelligence Family Involvement Generative Agent (AIFIGA) Program on Nursing Home Nursing Staff and Family and Residents'health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Family
Nursing Home
Digital Health
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 210
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: resident health-Geriatric Depression Scale (GDS)
timeFrame: baseline, 1 month, 3 months and 6 months
measure: resident health-Activity of daily living (ADL)
timeFrame: baseline, 1 month, 3 months and 6 months
measure: social support scale
timeFrame: baseline
measure: brief Center for Epidemiological Studies Depression Scale(CESD-10)
timeFrame: baseline, 1 month, 3 months and 6 months
measure: The General Health Questionnaire-12(GHQ-12)
timeFrame: baseline, 1 month, 3 months and 6 months
measure: Family Meaning of Nursing-Home Visits scale
timeFrame: baseline, 1 month, 3 months and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: Catholic Mercy Hospital Attached Nursing Home
Study officials:
affiliation: Chang Gung University
name: Hsiu Hsin Tsai, PhD
role: STUDY_CHAIR
References: