65 Years OlderNCT07091435
ChatGPT -Based Intervention for Social Frailty in Older Women With CHF : Gender Differences
A study testing ChatGPT and community social in people with 65 Years Older and CHF - Congestive Heart Failure, run by Chang Gung University of Science and Technology.
Trial summary
The study is planned to be completed over three years and will focus on 500 hospitalized older adults with a diagnosis of CHF. The Biopsychosocial model will be used to conduct this study. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- 65 Years Older, CHF - Congestive Heart Failure, Social Communication
- What is being tested?
- ChatGPT and community social
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 31 Jul 2028
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Participants must be 65 years or older.
- Diagnosis of CHF with a left ventricular ejection fraction (EF) of less than 40%
- Ability to communicate effectively in Mandarin or Taiwanese.
Who cannot join
- Patients diagnosed with unstable heart failure
- Severe Comorbidities, conditions such as end-stage renal disease, advanced hepatic dysfunction, or terminal malignancies.
- Severe cognitive deficits that impede the ability to provide informed consent or participate in study interventions.
- Uncorrected visual or hearing impairments that would hinder effective communication or interaction with the ChatGPT application.
- Active psychiatric conditions, including major depression or psychosis, that could interfere with study participation or adherence.
About this study
Official title: ChatGPT -Based Intervention for Social Frailty in Older Women With CHF : Gender Differences, Predictive Modeling, and Longitudinal Evaluation
The study is planned to be completed over three years and will focus on 500 hospitalized older adults with a diagnosis of CHF. The Biopsychosocial model will be used to conduct this study. Phase 1: This phase aims to determine the incidence rates of sarcopenia, frailty/social frailty among hospitalized older adults, and to compare these outcomes in gender differences. Sarcopenia will be identified according to the AWGS guidelines, while clinical characteristics, including ejection fraction, stage of CHF, and comorbidities, will be collected via chart review using the 2024 Guidelines of the Taiwan Society of Cardiology(Y. H. Li et al., 2024). Frailty and social frailty will be measured using the CFS, Tilburg Frailty Indicator (TFI), and Makizako's Social Frailty Questionnaire, respectively, and physical activity levels will be assessed with the International Physical Activity Questionnaire - Short Form (IPAQ-S). To develop a predictive model examining risk factors for social frailty and health outcomes, with a focus on gender differences, we will employ Structural Equation Modeling (SEM). SEM allows for the analysis of complex relationships among variables, facilitating a comprehensive understanding of how these factors interact differently across genders. Phase 2: A quasi-experimental design will be implemented, involving 174 hospitalized older adults with low social frailty scores. Participants will be randomly assigned to one of three groups. Group 1 will use the ChatGPT app for 15-30 minutes daily, with the app actively monitoring their emotional status and automatically notifying the research team and family members if signs of negative mood are detected. Group 2 will be encouraged to increase their social participation through community-based activities. The Control Group will continue their routine lifestyle without additional interventions. Before the intervention, one-on-one training will be provided to Group 1 participants on how to use ChatGPT. Key outcome measures, including mood status (loneliness, anxiety, and depression), physical activity (assessed via IPAQ-S), overall frailty (CFS \& TFI), social frailty scores, and other health indicators, will be assessed at baseline and immediately post-intervention. Phase 3: The aim of this phase is to monitor and compare the longitudinal health outcomes of interventions among the three groups. Key health outcomes will be assessed and compared every three months over a one-year period.
- Being tested
- ChatGPT, community social
- Keywords
- older women, social frailty, CHF
- Medical subject headings
- Heart Failure, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChatGPTBehavioural
Phase 2 Involves a quasi-experimental design with 174 participants identified as having low social frailty scores, randomly assigned to one of three groups: a ChatGPT intervention group engaging in daily 15-30-minute app-based conversations with emotional monitoring; a community social participation group attending regular social activities; and a control group maintaining routine activities. Outcomes related to emotional state, physical activity, social frailty, and prognosis will be assessed pre- and post-intervention.
community socialBehavioural
Phase 2 involves a quasi-experimental design with 174 participants identified as having low social frailty scores, randomly assigned to one of three groups: a ChatGPT intervention group engaging in daily 15-30-minute app-based conversations with emotional monitoring; a community social participation group attending regular social activities; and a control group maintaining routine activities. Outcomes related to emotional state, physical activity, social frailty, and prognosis will be assessed pre- and post-intervention.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Not described |
| ChatGPT intervention | Experimental | Not described Receives: Behavioral: ChatGPT |
| Community social participation group | Experimental | Not described Receives: Behavioral: community social |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tilburg Frailty Indicator (TFI)
Assesses multidimensional frailty across physical, psychological, and social domains using a 15-item questionnaire. It consists of two parts: the first part gathers data on determinants of frailty (e.g., age, gender, marital status), while the second part includes 15 items divided into physical (8 items), psychological (4 items), and social (3 items) domains. This instrument offers a holistic view of an individual's frailty status. The TFI has shown good internal consistency (Cronbach's α = 0.79) and predictive validity for adverse outcomes, including functional decline and mortality Score range : 0-15 Scores 0-4 Scores: non-frail ; 5 Scores or more: frail
Measured: Baseline, 3-month follow-up,6-month follow-up,12-month follow-up
Makizako Social Frailty Index
Assesses social frailty through a set of 5 questions related to social participation, activities, and support networks. The questionnaire has demonstrated good test-retest reliability and criterion validity in predicting adverse health outcomes such as reduced physical activity and functional decline. These instruments collectively provide a comprehensive framework for assessing physical, psychological, and social frailty, especially in studies involving older adults.
Score range : 0-5 Scores 0 Scores: non-Social Frailty ;
- Scores : Pre-Social Frailty ;
- Scores or more: Social Frailty
Measured: Baseline, 3-month follow-up,6-month follow-up,12-month follow-up
International Physical Activity Questionnaire - Short Form (IPAQ-S)
A self-reported measure assessing physical activity over the last seven days. It categorizes activity levels based on frequency and intensity, covering domains such as walking, moderate activity, and vigorous activity.
Calculate MET-minutes/week Category 1: Low No activity is reported \& Activity does not meet the criteria for Moderate or High categories.
Category 2: Moderate
Meets any of the following:
3 or more days of vigorous activity of at least 20 min/day ; 5 or more days of moderate activity and/or walking of at least 30 min/day ; 5 or more days of any combination of walking, moderate, or vigorous activities, achieving at least 600 MET-min/week Category 3: Vigorous
Meets either of the following:
At least 3 days, accumulating at least 1500 MET-min/week, OR 7 or more days of any combination of activities totaling ≥3000 MET-min/week
Measured: Baseline, 3-month follow-up,6-month follow-up,12-month follow-up
Minnesota Living with Heart Failure Questionnaire（MLHFQ）
One of the most widely used health-related quality of life questionnaires for patients with CHF.
Score range : 0-105 Scores 0-24 Scores: Low impact of heart failure on life ; 25-45 Scores: Moderate impact of heart failure on life ; 46 Scores or more: Serious impact of heart failure on life
Measured: Baseline, 3-month follow-up,6-month follow-up,12-month follow-up
UCLA Loneliness Scale
Measures subjective feelings of loneliness and social isolation. Score range : 6-18 Scores Higher total scores indicate greater feelings of loneliness.
Measured: Baseline, 3-month follow-up,6-month follow-up,12-month follow-up
Geriatric Depression Scale (GDS-15)
A shorter 15-item version and designed to screen for depression in older adults.
Scoring :
Each depressive answer scores 1 point. Some items count "Yes" as a point. Some items count "No" as a point. The maximum total score is 15. Items Scored as 1 Point for a "Yes" Answer:1, 5, 7, 11, 13 Items Scored as 1 Point for a "No" Answer:2, 3, 4, 6, 8, 9, 10, 12, 14, 15 Interpretation of Scores 0-6: Normal (no depression) ; 7-10: Moderate depression ; 11-15: Severe depression
Measured: Baseline, 3-month follow-up,6-month follow-up,12-month follow-up
Clinical Frailty Scale (CFS)
A 9-point scale that evaluates an individual's level of frailty based on their physical functioning and overall health status.
Scoring Range :
The scale ranges from 1 to 9, with higher scores indicating greater frailty.
Measured: Baseline, 3-month follow-up,6-month follow-up,12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 65 Years OlderStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, WANG, JENG, Chang Gung University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091435
- Sponsor's protocol ID
- 202500678B0
- Status last verified
- Aug 2025
- First submitted
- 22 Jul 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ChatGPT -Based Intervention for Social Frailty in Older Women With CHF : Gender Differences, Predictive Modeling, and Longitudinal Evaluation
- ClinicalTrials.gov ID
- NCT07091435
- Acronym / sponsor ID
- 202500678B0
- Keywords
- older women, social frailty, CHF
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chang Gung University of Science and TechnologyUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 29 Jul 2025 (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.
The study is planned to be completed over three years and will focus on 500 hospitalized older adults with a diagnosis of CHF. The Biopsychosocial model will be used to conduct this study. Phase 1: This phase aims to determine the incidence rates of sarcopenia, frailty/social frailty among hospitalized older adults, and to compare these outcomes in gender differences. Sarcopenia will be identified according to the AWGS guidelines, while clinical characteristics, including ejection fraction, stage of CHF, and comorbidities, will be collected via chart review using the 2024 Guidelines of the Taiwan Society of Cardiology(Y. H. Li et al., 2024). Frailty and social frailty will be measured using the CFS, Tilburg Frailty Indicator (TFI), and Makizako's Social Frailty Questionnaire, respectively, and physical activity levels will be assessed with the International Physical Activity Questionnaire - Short Form (IPAQ-S). To develop a predictive model examining risk factors for social frailty and health outcomes, with a focus on gender differences, we will employ Structural Equation Modeling (SEM). SEM allows for the analysis of complex relationships among variables, facilitating a comprehensive understanding of how these factors interact differently across genders. Phase 2: A quasi-experimental design will be implemented, involving 174 hospitalized older adults with low social frailty scores. Participants will be randomly assigned to one of three groups. Group 1 will use the ChatGPT app for 15-30 minutes daily, with the app actively monitoring their emotional status and automatically notifying the research team and family members if signs of negative mood are detected. Group 2 will be encouraged to increase their social participation through community-based activities. The Control Group will continue their routine lifestyle without additional interventions. Before the intervention, one-on-one training will be provided to Group 1 participants on how to use ChatGPT. Key outcome measures, including mood status (loneliness, anxiety, and depression), physical activity (assessed via IPAQ-S), overall frailty (CFS \& TFI), social frailty scores, and other health indicators, will be assessed at baseline and immediately post-intervention. Phase 3: The aim of this phase is to monitor and compare the longitudinal health outcomes of interventions among the three groups. Key health outcomes will be assessed and compared every three months over a one-year period.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | – |
| ChatGPT intervention | Experimental | Behavioral: ChatGPT |
| Community social participation group | Experimental | Behavioral: community social |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Participants must be 65 years or older.
- Diagnosis of CHF with a left ventricular ejection fraction (EF) of less than 40%
- Ability to communicate effectively in Mandarin or Taiwanese.
Key exclusion criteria (5 listed)
- Patients diagnosed with unstable heart failure
- Severe Comorbidities, conditions such as end-stage renal disease, advanced hepatic dysfunction, or terminal malignancies.
- Severe cognitive deficits that impede the ability to provide informed consent or participate in study interventions.
- Uncorrected visual or hearing impairments that would hinder effective communication or interaction with the ChatGPT application.
- Active psychiatric conditions, including major depression or psychosis, that could interfere with study participation or adherence.
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 |
|---|---|---|
| ChatGPTPhase 2 Involves a quasi-experimental design with 174 participants identified as having low social frailty scores, randomly assigned to one of three groups: a ChatGPT intervention group engaging in daily 15-30-minute app-based conversations with emotional monitoring; a community social participation group attending regular social activities; and a control group maintaining routine activities. Outcomes related to emotional state, physical activity, social frailty, and prognosis will be assessed pre- and post-intervention. | Behavioural | ChatGPT intervention |
| community socialPhase 2 involves a quasi-experimental design with 174 participants identified as having low social frailty scores, randomly assigned to one of three groups: a ChatGPT intervention group engaging in daily 15-30-minute app-based conversations with emotional monitoring; a community social participation group attending regular social activities; and a control group maintaining routine activities. Outcomes related to emotional state, physical activity, social frailty, and prognosis will be assessed pre- and post-intervention. | Behavioural | Community social participation group |
Primary outcome
Tilburg Frailty Indicator (TFI)
Time frame: Baseline, 3-month follow-up,6-month follow-up,12-month follow-up
Assesses multidimensional frailty across physical, psychological, and social domains using a 15-item questionnaire. It consists of two parts: the first part gathers data on determinants of frailty (e.g., age, gender, marital status), while the second part includes 15 items divided into physical (8 items), psychological (4 items), and social (3 items) domains. This instrument offers a holistic view of an individual's frailty status. The TFI has shown good internal consistency (Cronbach's α = 0.79) and predictive validity for adverse outcomes, including functional decline and mortality Score range : 0-15 Scores 0-4 Scores: non-frail ; 5 Scores or more: frail
Makizako Social Frailty Index
Time frame: Baseline, 3-month follow-up,6-month follow-up,12-month follow-up
Assesses social frailty through a set of 5 questions related to social participation, activities, and support networks. The questionnaire has demonstrated good test-retest reliability and criterion validity in predicting adverse health outcomes such as reduced physical activity and functional decline. These instruments collectively provide a comprehensive framework for assessing physical, psychological, and social frailty, especially in studies involving older adults. Score range : 0-5 Scores 0 Scores: non-Social Frailty ; 1. Scores : Pre-Social Frailty ; 2. Scores or more: Social Frailty
International Physical Activity Questionnaire - Short Form (IPAQ-S)
Time frame: Baseline, 3-month follow-up,6-month follow-up,12-month follow-up
A self-reported measure assessing physical activity over the last seven days. It categorizes activity levels based on frequency and intensity, covering domains such as walking, moderate activity, and vigorous activity. Calculate MET-minutes/week Category 1: Low No activity is reported \& Activity does not meet the criteria for Moderate or High categories. Category 2: Moderate Meets any of the following: 3 or more days of vigorous activity of at least 20 min/day ; 5 or more days of moderate activity and/or walking of at least 30 min/day ; 5 or more days of any combination of walking, moderate, or vigorous activities, achieving at least 600 MET-min/week Category 3: Vigorous Meets either of the following: At least 3 days, accumulating at least 1500 MET-min/week, OR 7 or more days of any combination of activities totaling ≥3000 MET-min/week
Minnesota Living with Heart Failure Questionnaire（MLHFQ）
Time frame: Baseline, 3-month follow-up,6-month follow-up,12-month follow-up
One of the most widely used health-related quality of life questionnaires for patients with CHF. Score range : 0-105 Scores 0-24 Scores: Low impact of heart failure on life ; 25-45 Scores: Moderate impact of heart failure on life ; 46 Scores or more: Serious impact of heart failure on life
UCLA Loneliness Scale
Time frame: Baseline, 3-month follow-up,6-month follow-up,12-month follow-up
Measures subjective feelings of loneliness and social isolation. Score range : 6-18 Scores Higher total scores indicate greater feelings of loneliness.
Geriatric Depression Scale (GDS-15)
Time frame: Baseline, 3-month follow-up,6-month follow-up,12-month follow-up
A shorter 15-item version and designed to screen for depression in older adults. Scoring : Each depressive answer scores 1 point. Some items count "Yes" as a point. Some items count "No" as a point. The maximum total score is 15. Items Scored as 1 Point for a "Yes" Answer:1, 5, 7, 11, 13 Items Scored as 1 Point for a "No" Answer:2, 3, 4, 6, 8, 9, 10, 12, 14, 15 Interpretation of Scores 0-6: Normal (no depression) ; 7-10: Moderate depression ; 11-15: Severe depression
Clinical Frailty Scale (CFS)
Time frame: Baseline, 3-month follow-up,6-month follow-up,12-month follow-up
A 9-point scale that evaluates an individual's level of frailty based on their physical functioning and overall health status. Scoring Range : The scale ranges from 1 to 9, with higher scores indicating greater frailty.
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 15 Aug 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ChatGPT and community social in people with 65 Years Older and CHF - Congestive Heart Failure, run by Chang Gung University of Science and Technology.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tilburg Frailty Indicator (TFI) (time frame: Baseline, 3-month follow-up,6-month follow-up,12-month follow-up). The study lists 7 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 15 Aug 2025.