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Recruiting NCT06574438

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

No phase Interventional Family Nursing Home Digital Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AIFIGA program.
Who it may be relevant to
Registry conditions: Family, Nursing Home, Digital Health. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • resident health-Geriatric Depression Scale (GDS) [Time frame: 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]
  • social support scale [Time frame: baseline]
  • brief Center for Epidemiological Studies Depression Scale(CESD-10) [Time frame: 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]
  • Family Meaning of Nursing-Home Visits scale [Time frame: baseline, 1 month, 3 months and 6 months]

Eligibility criteria

Inclusion criteria

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

  • 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.

Exclusion criteria

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

Taiwan · 1 center
  • Catholic Mercy Hospital Attached Nursing Home — Hsinchu

Identifiers

NCT: NCT06574438 · 202400678B0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗