FamilyNCT06574438
The Effectiveness of AIFIGA Program on Nursing Home Nursing Staff and Family and Residents'Health
A study testing AIFIGA program in people with Family and Nursing Home, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Family, Nursing Home, Digital Health
- What is being tested?
- AIFIGA program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Sep 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Catholic Mercy Hospital Attached Nursing Home
Hsinchu
Pei-Ling Yu, MSN, 091033@mercy.org.tw
About this study
Official title: 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.
- Conditions
- Family, Nursing Home, Digital Health
- Being tested
- AIFIGA program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIFIGA programBehavioural
receives the Artificial Intelligence Family Involvement Generative Agent (AIFIGA) program and uses it for 3 months
| Study group | Role | What they receive |
|---|---|---|
| AIFIGA group | Experimental | receives the AIFIGA program and uses it for 3 months Receives: Behavioral: AIFIGA program |
| control group | No intervention | receives only routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: baseline, 1 month, 3 months and 6 months
Family Meaning of Nursing-Home Visits scale
measurement of family visiting involvement meaning
Measured: baseline, 1 month, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start24 Sep 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FamilyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsiu Hsin Tsai, PhD, Study chair, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574438
- Sponsor's protocol ID
- 202400678B0
- Status last verified
- Jun 2025
- First submitted
- 25 Aug 2024
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Artificial Intelligence Family Involvement Generative Agent (AIFIGA) Program on Nursing Home Nursing Staff and Family and Residents'Health
- ClinicalTrials.gov ID
- NCT06574438
- Acronym / sponsor ID
- 202400678B0
- Conditions
- Family, Nursing Home, Digital Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIFIGA group | Experimental | Behavioral: AIFIGA programreceives the AIFIGA program and uses it for 3 months |
| control group | No intervention | –receives only routine care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIFIGA programreceives the Artificial Intelligence Family Involvement Generative Agent (AIFIGA) program and uses it for 3 months | Behavioural | AIFIGA group |
Primary outcome
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.)
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)
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)
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)
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)
Family Meaning of Nursing-Home Visits scale
Time frame: baseline, 1 month, 3 months and 6 months
measurement of family visiting involvement meaning
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hsiu Hsin Tsai, PhD study chair
Chang Gung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AIFIGA program in people with Family and Nursing Home, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsiu Hsin Tsai, PhD (032118800 ext. 5075, kitty@mail.cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
resident health-Geriatric Depression Scale (GDS) (time frame: baseline, 1 month, 3 months and 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.