65 Years OlderNCT07100366
Comparing Sarcopenia , Physical, Psychological and Social Frailty in Hospitalized Older Women Congestive Heart Failure in Metropolitan and Rural Settings
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
Frailty-encompassing sarcopenia, physical, psychological, and social frailty-is common among older adults with congestive heart failure (CHF) and contributes to adverse outcomes such as rehospitalization, mortality, and poor quality of life. 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
- 200 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: Comparing Sarcopenia, Physical, Psychological and Social Frailty in Hospitalized Older Women Congestive Heart Failure (CHF) in Metropolitan and Rural Settings: a 3-Year Longitudinal Study Incorporating Information and Communication Technology (ICT) Interventions.
Frailty-encompassing sarcopenia, physical, psychological, and social frailty-is common among older adults with congestive heart failure (CHF) and contributes to adverse outcomes such as rehospitalization, mortality, and poor quality of life. However, few studies have compared these conditions in congestive heart failure (CHF) patients, particularly in elderly women in Taiwan, and effective, tailored Information and Communication Technology (ICT) interventions are scarce.
This three-year study aims to (1) compare baseline characteristics and incidence rates of sarcopenia, physical, psychological, and social frailty among hospitalized older women with congestive heart failure (CHF) in metropolitan versus rural hospitals; (2) evaluate risk factors associated with physical, psychological, and social frailty; (3) monitor health outcomes (rehospitalization, mortality, quality of life) during a one-year follow-up; and (4) assess the effectiveness of an Information and Communication Technology (ICT) intervention designed to enhance social connectivity and emotional well-being.
Read more
In Phase 1, clinical data-including ejection fraction, congestive heart failure (CHF) stage, and comorbidity -will be collected using the 2024 Guidelines of the Taiwan Society of Cardiology, while sarcopenia will be identified via Asian Working Group for Sarcopenia (AWGS) guidelines. Physical, psychological, and social frail will be measured with the Tilburg Frailty Indicator (TFI) and Makizako's Social Frailty Questionnaire, respectively, and physical activity will be assessed using the IPAQ-S.
Phase 2 will involve quarterly follow-ups over one year to compare health outcomes between metropolitan and rural settings, and to develop a predictive model of these outcomes. Phase 3 employs a quasi-experimental design with 90 participants randomized into three groups: an Information and Communication Technology (ICT) intervention group (using a dedicated app for at least 15 minutes daily, which monitors emotional status), a community-based social participation group, and a control group maintaining routine care. Key outcomes (mood, physical activity, frailty measures, and clinical status) will be assessed at baseline, immediately post-intervention, and three months thereafter.
This study is expected to identify significant differences between settings and demonstrate that a tailored Information and Communication Technology (ICT) intervention can improve social connectivity and clinical outcomes in older women with congestive heart failure (CHF).
- Conditions
- 65 Years Older, CHF - Congestive Heart Failure, Social Communication, Sarcopenia in Elderly
- Being tested
- ChatGPT, community social
- Keywords
- Frailty, Sarcopenia, Social Frailty, Congestive Heart Failure, Older Women, ICT Intervention, Metropolitan, Rural
- Medical subject headings
- Heart Failure, Communication, Frailty, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChatGPTBehavioural
Phase 3:In Experimental Group 1, participants will be invited to use the ICT app, which they are encouraged to engage with for at least 15 minutes daily. This app is designed to actively monitor the users' emotional status and automatically notify both the research team and family members if any negative mood is detected.
community socialBehavioural
Phase 3:In Experimental Group 2, participants will be encouraged to increase their social participation through community-based activities, while the Control Group will continue with their routine lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Not described |
| ChatGPT intervention | Experimental | ChatGPT intervention 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
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
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
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
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
Geriatric Depression Scale (GDS-15)
A shorter 15-item version and designed to screen for depression in older adults.
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100366
- Sponsor's protocol ID
- 202500795B0
- Status last verified
- Aug 2025
- First submitted
- 28 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
- Comparing Sarcopenia, Physical, Psychological and Social Frailty in Hospitalized Older Women Congestive Heart Failure (CHF) in Metropolitan and Rural Settings: a 3-Year Longitudinal Study Incorporating Information and Communication Technology (ICT) Interventions.
- ClinicalTrials.gov ID
- NCT07100366
- Acronym / sponsor ID
- 202500795B0
- Conditions
- 65 Years Older, CHF - Congestive Heart Failure, Social Communication, Sarcopenia in Elderly
- Keywords
- Frailty, Sarcopenia, Social Frailty, Congestive Heart Failure, Older Women, ICT Intervention, Metropolitan, Rural
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chang Gung University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 3 Aug 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.
Frailty-encompassing sarcopenia, physical, psychological, and social frailty-is common among older adults with congestive heart failure (CHF) and contributes to adverse outcomes such as rehospitalization, mortality, and poor quality of life. However, few studies have compared these conditions in congestive heart failure (CHF) patients, particularly in elderly women in Taiwan, and effective, tailored Information and Communication Technology (ICT) interventions are scarce.
This three-year study aims to (1) compare baseline characteristics and incidence rates of sarcopenia, physical, psychological, and social frailty among hospitalized older women with congestive heart failure (CHF) in metropolitan versus rural hospitals; (2) evaluate risk factors associated with physical, psychological, and social frailty; (3) monitor health outcomes (rehospitalization, mortality, quality of life) during a one-year follow-up; and (4) assess the effectiveness of an Information and Communication Technology (ICT) intervention designed to enhance social connectivity and emotional well-being.
In Phase 1, clinical data-including ejection fraction, congestive heart failure (CHF) stage, and comorbidity -will be collected using the 2024 Guidelines of the Taiwan Society of Cardiology, while sarcopenia will be identified via Asian Working Group for Sarcopenia (AWGS) guidelines. Physical, psychological, and social frail will be measured with the Tilburg Frailty Indicator (TFI) and Makizako's Social Frailty Questionnaire, respectively, and physical activity will be assessed using the IPAQ-S.
Phase 2 will involve quarterly follow-ups over one year to compare health outcomes between metropolitan and rural settings, and to develop a predictive model of these outcomes. Phase 3 employs a quasi-experimental design with 90 participants randomized into three groups: an Information and Communication Technology (ICT) intervention group (using a dedicated app for at least 15 minutes daily, which monitors emotional status), a community-based social participation group, and a control group maintaining routine care. Key outcomes (mood, physical activity, frailty measures, and clinical status) will be assessed at baseline, immediately post-intervention, and three months thereafter.
This study is expected to identify significant differences between settings and demonstrate that a tailored Information and Communication Technology (ICT) intervention can improve social connectivity and clinical outcomes in older women with congestive heart failure (CHF).
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: ChatGPTChatGPT intervention |
| 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 3:In Experimental Group 1, participants will be invited to use the ICT app, which they are encouraged to engage with for at least 15 minutes daily. This app is designed to actively monitor the users' emotional status and automatically notify both the research team and family members if any negative mood is detected. | Behavioural | ChatGPT intervention |
| community socialPhase 3:In Experimental Group 2, participants will be encouraged to increase their social participation through community-based activities, while the Control Group will continue with their routine lifestyle. | Behavioural | Community social participation group |
Primary outcome
Tilburg Frailty Indicator (TFI)
Time frame: Baseline, 3-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
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
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
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
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
A shorter 15-item version and designed to screen for depression in older adults. 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
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). 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.