Post-Intensive Care SyndromeNCT07141420
Application of Large Language Models Techniques to Post-ICU Syndrome Management in Critically Ill Patients: A Fully Longitudinal Mixed Study
A study testing Routine Care, Health Promotion Model-Based Optimized Program and LLM-Enhanced Optimized Program in people with Post-Intensive Care Syndrome, run by The Affiliated Hospital Of Guizhou Medical University at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate whether Large Language Models (LLMs) combined with an optimized care program can effectively manage Post-Intensive Care Syndrome (PICS) in adult ICU survivors (aged ≥18 years) discharged from a tertiary hospital in China. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Post-Intensive Care Syndrome
- What is being tested?
- Routine Care, Health Promotion Model-Based Optimized Program and LLM-Enhanced Optimized Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 20 Feb 2026
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICU hospitalization duration > 24 hours.
- Age ≥ 18 years.
- Conscious at ICU discharge, able to communicate without barriers.
- Provide informed consent to participate.
- Regular access to and usage of smart electronic devices.
Who cannot join
- Previous ICU admission (≥24h) within 3 months before the current hospitalization.
- Transferred to another ICU during the current hospitalization.
- Pre-existing cognitive impairment (Blessed Dementia Rating Scale [BDRS] score >4 before ICU admission).
- Severe communication barriers:
- Hearing impairment Dysarthria Other conditions preventing follow-up assessments.
- Critically unstable condition preventing questionnaire completion.
- Infrequent/no experience using smart electronic devices (e.g., smartphones, tablets).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004
About this study
The goal of this clinical trial is to evaluate whether Large Language Models (LLMs) combined with an optimized care program can effectively manage Post-Intensive Care Syndrome (PICS) in adult ICU survivors (aged ≥18 years) discharged from a tertiary hospital in China. The main questions it aims to answer are:
- Does the intervention (optimized program + LLMs) improve physical, psychological, cognitive, and social function recovery compared to standard care or the optimized program alone?
- How do patients experience and perceive the utility of LLMs in PICS self-management during recovery?
Read more
Researchers will compare three groups:
- Group A (routine care)
- Group B (optimized program without LLMs)
- Group C (optimized program + LLMs) to see if adding LLMs significantly enhances PICS symptom management, patient self-efficacy, and quality of life over 6 months post-discharge.
Participants will:
- Install and use the Kimi Smart Assistant LLM (Group C only) for health queries under nurse supervision.
- Complete standardized questionnaires at discharge (baseline), 7 days, 1 month, 3 months, and 6 months post-discharge:
- PICS Symptom Questionnaire (PICSQ)
- Pittsburgh Sleep Quality Index (PSQI)
- Anxiety (GAD-7) and Depression (PHQ-9) scales
- Self-Management Ability Scale (AHSMSRS)
- Attend semi-structured interviews (Group C only) at 3 and 6 months to share experiences with LLM use.
- Conditions
- Post-Intensive Care Syndrome
- Being tested
- Routine Care, Health Promotion Model-Based Optimized Program, LLM-Enhanced Optimized Program
- Medical subject headings
- postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine CareBehavioural
Participants receive standard post-ICU follow-up care according to hospital protocols . This includes routine health assessments and general rehabilitation guidance at designated intervals (discharge, 1/3/6 months post-discharge). No structured PICS management program or AI technology is provided.
Health Promotion Model-Based Optimized ProgramBehavioural
An evidence-based, multidisciplinary rehabilitation protocol for Post-Intensive Care Syndrome (PICS) management, developed using the Health Promotion Model (HPM). It includes:
Personalized rehabilitation plans addressing physical, cognitive, and psychological recovery.
Structured follow-up at discharge, 1/3/6 months post-discharge. Components: Physical function training, cognitive exercises, anxiety/depression coping strategies, and sleep hygiene education.
Delivery: Clinician-guided (no AI/technology involved). Developed via literature review and validated by ICU physicians and nursing experts .
LLM-Enhanced Optimized ProgramBehavioural
Combines the HPM-Based Optimized Program with Large Language Model (LLM) technology for dynamic personalization:
AI-generated rehabilitation plans: ChatGPT-4 synthesizes patient data (baseline + follow-ups) to create/update monthly plans, reviewed by a multidisciplinary expert team.
Patient-facing LLM tool: "Kimi Smart Assistant" installed for daily health queries under strict safety protocols (all outputs validated by nurses via WeChat).
Phased implementation:
Pre-discharge: LLM training + baseline plan generation. 1/3/6 months: Plan updates + outcome tracking. 3/6 months: Semi-structured interviews on LLM experience. Includes LLM usage guidelines and expert validation safeguards .
| Study group | Role | What they receive |
|---|---|---|
| Routine Care Group | Other | Participants receive standard post-ICU follow-up care according to hospital protocols . This includes routine health assessments and general rehabilitation guidance at designated intervals (discharge, 7 days, 1/3/6 months post-discharge). No structured PICS management program or AI technology is provided. Receives: Behavioral: Routine Care |
| Optimized Program Group | Other | Participants receive an evidence-based, optimized PICS management program developed using the Health Promotion Model (HPM). This includes personalized rehabilitation plans, psychological support, and education tailored to PICS symptoms. Interventions are delivered by clinical staff at discharge, 7 days, and 1/3/6 months post-discharge. No AI/LLM technology is used. Receives: Behavioral: Health Promotion Model-Based Optimized Program; Behavioral: LLM-Enhanced Optimized Program |
| Optimized Program + LLMs Group | Other | Participants receive the same optimized PICS program as Group B, enhanced with Large Language Models (LLMs). Key components:
Personalized AI-generated plans: ChatGPT-4 synthesizes patient data (baseline + follow-ups) to create monthly rehabilitation plans, reviewed by a multidisciplinary expert team.
LLM access: Installation of "Kimi Smart Assistant" for daily health queries. Safety protocols: Patients must validate LLM advice with nurses via WeChat before use .
Phased intervention:
Pre-discharge: LLM training + baseline plan generation.
1 month: Plan updates based on new data. 3/6 months: Plan updates + semi-structured interviews about LLM experience. Receives: Behavioral: LLM-Enhanced Optimized Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Post-Intensive Care Syndrome (PICS) Symptom Severity
- Total score of the Chinese Version of the Post-Intensive Care Syndrome Questionnaire (PICSQ).
Domains: Physical function (6 items), cognitive impairment (6 items), psychological symptoms (6 items).
Scoring: 18 items × 0-3 points = 0-54 total; higher scores = worse symptoms.
- Total score of the Pittsburgh Sleep Quality Index (PSQI). Scoring: 7 components × 0-3 points = 0-21 total; higher scores = poorer sleep.
- Recall experiences measured by the Chinese ICU Memory Tool (ICUMT). Format: 14-item mixed open/closed questions about ICU admission, treatment, and discharge memories.
- Anxiety: GAD-7 score (0-21; higher = worse anxiety). Depression: PHQ-9 score (0-27; higher = worse depression).
Measured: Measured at baseline (pre-discharge), 1 month, 3 months, and 6 months post-discharge.
Secondary outcomes (2)
Self-Management Ability
- Total score of the Adults Health Self-Management Ability Rating Scale (AHSMSRS).
Scoring: 38 items × 1-3 points = 38-114 total; higher scores = poorer self-management.
Measured: 1m, 3m, 6m post-discharge.
Patient Experience with LLMs
Qualitative insights from semi-structured interviews based on the Technology Acceptance Model (TAM).
Measured: 3 months and 6 months post-discharge (Group C only).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Jun 2025
- Primary completion31 Jan 2026 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Intensive Care SyndromeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital Of Guizhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141420
- Sponsor's protocol ID
- 2024-171
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 26 Aug 2025
- Results posted
- 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 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Large Language Models Techniques to Post-ICU Syndrome Management in Critically Ill Patients: A Fully Longitudinal Mixed Study
- ClinicalTrials.gov ID
- NCT07141420
- Acronym / sponsor ID
- 2024-171
- Conditions
- Post-Intensive Care Syndrome
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The Affiliated Hospital Of Guizhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 26 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.
The goal of this clinical trial is to evaluate whether Large Language Models (LLMs) combined with an optimized care program can effectively manage Post-Intensive Care Syndrome (PICS) in adult ICU survivors (aged ≥18 years) discharged from a tertiary hospital in China. The main questions it aims to answer are:
- Does the intervention (optimized program + LLMs) improve physical, psychological, cognitive, and social function recovery compared to standard care or the optimized program alone?
- How do patients experience and perceive the utility of LLMs in PICS self-management during recovery?
Researchers will compare three groups:
- Group A (routine care)
- Group B (optimized program without LLMs)
- Group C (optimized program + LLMs) to see if adding LLMs significantly enhances PICS symptom management, patient self-efficacy, and quality of life over 6 months post-discharge.
Participants will:
- Install and use the Kimi Smart Assistant LLM (Group C only) for health queries under nurse supervision.
- Complete standardized questionnaires at discharge (baseline), 7 days, 1 month, 3 months, and 6 months post-discharge:
- PICS Symptom Questionnaire (PICSQ)
- Pittsburgh Sleep Quality Index (PSQI)
- Anxiety (GAD-7) and Depression (PHQ-9) scales
- Self-Management Ability Scale (AHSMSRS)
- Attend semi-structured interviews (Group C only) at 3 and 6 months to share experiences with LLM use.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Routine Care Group | Other | Behavioral: Routine CareParticipants receive standard post-ICU follow-up care according to hospital protocols . This includes routine health assessments and general rehabilitation guidance at designated intervals (discharge, 7 days, 1/3/6 months post-discharge). No structured PICS management program or AI technology is provided. |
| Optimized Program Group | Other | Behavioral: Health Promotion Model-Based Optimized Program, Behavioral: LLM-Enhanced Optimized ProgramParticipants receive an evidence-based, optimized PICS management program developed using the Health Promotion Model (HPM). This includes personalized rehabilitation plans, psychological support, and education tailored to PICS symptoms. Interventions are delivered by clinical staff at discharge, 7 days, and 1/3/6 months post-discharge. No AI/LLM technology is used. |
| Optimized Program + LLMs Group | Other | Behavioral: LLM-Enhanced Optimized ProgramParticipants receive the same optimized PICS program as Group B, enhanced with Large Language Models (LLMs). Key components: Personalized AI-generated plans: ChatGPT-4 synthesizes patient data (baseline + follow-ups) to create monthly rehabilitation plans, reviewed by a multidisciplinary expert team. LLM access: Installation of "Kimi Smart Assistant" for daily health queries. Safety protocols: Patients must validate LLM advice with nurses via WeChat before use . Phased intervention: Pre-discharge: LLM training + baseline plan generation. 1 month: Plan updates based on new data. 3/6 months: Plan updates + semi-structured interviews about LLM experience. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ICU hospitalization duration > 24 hours.
- Age ≥ 18 years.
- Conscious at ICU discharge, able to communicate without barriers.
- Provide informed consent to participate.
- Regular access to and usage of smart electronic devices.
Key exclusion criteria (7 listed)
- Previous ICU admission (≥24h) within 3 months before the current hospitalization.
- Transferred to another ICU during the current hospitalization.
- Pre-existing cognitive impairment (Blessed Dementia Rating Scale [BDRS] score >4 before ICU admission).
- Severe communication barriers:
- Hearing impairment Dysarthria Other conditions preventing follow-up assessments.
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 |
|---|---|---|
| Routine CareParticipants receive standard post-ICU follow-up care according to hospital protocols . This includes routine health assessments and general rehabilitation guidance at designated intervals (discharge, 1/3/6 months post-discharge). No structured PICS management program or AI technology is provided. | Behavioural | Routine Care Group |
| Health Promotion Model-Based Optimized ProgramAn evidence-based, multidisciplinary rehabilitation protocol for Post-Intensive Care Syndrome (PICS) management, developed using the Health Promotion Model (HPM). It includes: Personalized rehabilitation plans addressing physical, cognitive, and psychological recovery. Structured follow-up at discharge, 1/3/6 months post-discharge. Components: Physical function training, cognitive exercises, anxiety/depression coping strategies, and sleep hygiene education. Delivery: Clinician-guided (no AI/technology involved). Developed via literature review and validated by ICU physicians and nursing experts . | Behavioural | Optimized Program Group |
| LLM-Enhanced Optimized ProgramCombines the HPM-Based Optimized Program with Large Language Model (LLM) technology for dynamic personalization: AI-generated rehabilitation plans: ChatGPT-4 synthesizes patient data (baseline + follow-ups) to create/update monthly plans, reviewed by a multidisciplinary expert team. Patient-facing LLM tool: "Kimi Smart Assistant" installed for daily health queries under strict safety protocols (all outputs validated by nurses via WeChat). Phased implementation: Pre-discharge: LLM training + baseline plan generation. 1/3/6 months: Plan updates + outcome tracking. 3/6 months: Semi-structured interviews on LLM experience. Includes LLM usage guidelines and expert validation safeguards . | Behavioural | Optimized Program + LLMs Group, Optimized Program Group |
Primary outcome
Change in Post-Intensive Care Syndrome (PICS) Symptom Severity
Time frame: Measured at baseline (pre-discharge), 1 month, 3 months, and 6 months post-discharge.
- Total score of the Chinese Version of the Post-Intensive Care Syndrome Questionnaire (PICSQ). Domains: Physical function (6 items), cognitive impairment (6 items), psychological symptoms (6 items). Scoring: 18 items × 0-3 points = 0-54 total; higher scores = worse symptoms. * Total score of the Pittsburgh Sleep Quality Index (PSQI). Scoring: 7 components × 0-3 points = 0-21 total; higher scores = poorer sleep. * Recall experiences measured by the Chinese ICU Memory Tool (ICUMT). Format: 14-item mixed open/closed questions about ICU admission, treatment, and discharge memories. * Anxiety: GAD-7 score (0-21; higher = worse anxiety). Depression: PHQ-9 score (0-27; higher = worse depression).
2 secondary outcomes
Self-Management Ability
Time frame: 1m, 3m, 6m post-discharge.
Patient Experience with LLMs
Time frame: 3 months and 6 months post-discharge (Group C only).
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 26 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Care, Health Promotion Model-Based Optimized Program and LLM-Enhanced Optimized Program in people with Post-Intensive Care Syndrome, run by The Affiliated Hospital Of Guizhou Medical University at 1 site in China.
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 5 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 26 Aug 2025. 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 China. 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?
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?
Change in Post-Intensive Care Syndrome (PICS) Symptom Severity (time frame: Measured at baseline (pre-discharge), 1 month, 3 months, and 6 months post-discharge.). 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 26 Aug 2025.