ICU SurvivorsiCARENCT06997822
Integrated Recovery Program for Critical Illness
A study testing LINE Bot-Based Remote Care Combined with In-Person Post-ICU Clinic in people with ICU Survivors, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study aims to investigate the effects of the Integrated Critical Illness Aftercare and Recovery Enhancement (I-CARE) program on reducing healthcare burden and improving functional outcomes in ICU survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Survivors
- What is being tested?
- LINE Bot-Based Remote Care Combined with In-Person Post-ICU Clinic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Nov 2025to 31 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICU survivors who had experienced endotracheal intubation and mechanical ventilation treatment.
Who cannot join
- ICU survivors who are unable to walk independently before admission
- ICU survivors who are unable to receive assessment (e.g., dementia or mental retardation)
- ICU survivors who don't have a smartphone.
- ICU survivors were discharged to institutional care facilities
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
National Taiwan University Hospital
Taipei, 10055
Cheryl Chia-Hui Chen, PhD, 886-2-23123456 ext. 288438, cherylchen@ntu.edu.tw
About this study
Official title: Integrated Critical Illness Aftercare and Recovery Enhancement (I-CARE) Program
This study aims to investigate the effects of the Integrated Critical Illness Aftercare and Recovery Enhancement (I-CARE) program on reducing healthcare burden and improving functional outcomes in ICU survivors. The I-CARE program combines remote support via LINE Bot Care with in-person post-ICU recovery clinic visits. The study will assess whether this integrated care model reduces unplanned hospital readmissions and emergency department visits within six months after discharge, and improves physical and cognitive outcomes at 3 and 6 months post-discharge. Additionally, the study will evaluate the impact of a built-in patient-nurse interaction feature on ICU nurses' burnout and intention to leave, measured every six months over a two-year period.
Read the detailed description
This randomized clinical trial is designed to evaluate the effectiveness of the Integrated Critical Illness Aftercare and Recovery Enhancement (I-CARE) program for survivors of critical illness discharged from the intensive care unit (ICU). The I-CARE program integrates a LINE Bot-based remote monitoring and support system with structured, in-person post-ICU recovery clinic visits. The primary objective is to determine whether this comprehensive care model can reduce the incidence of unplanned hospital readmissions and emergency department visits within six months after hospital discharge.
Secondary outcomes focus on functional recovery and include assessments of physical mobility (e.g., ability to transition from sit to stand), inspiratory muscle strength, body weight changes, presence of dysphagia, and cognitive function at 3 and 6 months post-discharge.
In addition, the LINE Bot Care system incorporates an interactive feature titled "Thanks to Nurses," which enables ICU survivors to share personal reflections, such as short messages, photos, diary entries, stickers, and audio clips, with their ICU care team. This bidirectional communication channel is intended to enhance emotional support and foster a sense of connection between patients and healthcare providers. The study will evaluate the impact of this feature on ICU nurses' professional well-being, specifically measuring levels of burnout and intention to leave the profession at 6, 12, 18, and 24 months after implementation, using a pre-post intervention design.
- Conditions
- ICU Survivors
- Being tested
- LINE Bot-Based Remote Care Combined with In-Person Post-ICU Clinic
- Keywords
- ICU survivors, Physical function, Cognitive, Weight loss
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LINE Bot-Based Remote Care Combined with In-Person Post-ICU ClinicBehavioural
Participants in this group will receive the I-CARE intervention, which includes two components: (1) a LINE Bot-based remote care system providing scheduled health education, functional assessments, and reminders tailored to ICU survivors, and (2) structured in-person visits to a post-ICU recovery clinic, where multidisciplinary professionals provide follow-up assessments and individualized rehabilitation guidance. The LINE Bot also features an interactive module ("Thanks to Nurses") that allows patients to send messages, images, or audio clips to their ICU care team, with optional reciprocal feedback. The intervention will be delivered for up to 6 months following hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| LINE Bot-Based Remote Care Combined with In-Person Post-ICU Clinic | Experimental | LINE Bot-Based Remote Care includes instructional videos for basic mobility skills, recommended exercise practices, cognitive training, and nutritional education. In addition, survivors can report their signs and symptoms to request relevant educational content. At 3 months, participants will attend a post-ICU clinic for comprehensive assessment, necessary interventions, and care transition planning. Receives: Behavioral: LINE Bot-Based Remote Care Combined with In-Person Post-ICU Clinic |
| Non-Interactive LINE Bot + Assessment-Only Clinic | No intervention | Participants in the control group will be invited to join an official LINE chat, which will not provide any interventions or educational content. They will, however, receive a post-ICU assessment clinic visit at the 3-month follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of unplanned hospital readmissions
Measured: 1, 2, 3, 4, 5, and 6 months after discharge
Incidence of emergency department visits
Measured: 1, 2, 3, 4, 5, and 6 months after discharge
Secondary outcomes (11)
Barthel Index
The Barthel Index is a validated instrument used to assess functional independence in activities of daily living (ADLs). It evaluates a person's ability to perform ten basic self-care and mobility tasks, such as feeding, bathing, dressing, grooming, bowel and bladder control, toileting, chair/bed transfers, ambulation, and stair climbing. Scores range from 0 to 100, with higher scores indicating greater independence.
Measured: Immediately after ICU discharge and 0, 3, and 6 months after discharge
Maximal inspiratory pressure
Maximal Inspiratory Pressure (MIP) is a measure of respiratory muscle strength, specifically the strength of the diaphragm and other inspiratory muscles. It is assessed by having the individual inhale as forcefully as possible against an occluded airway, typically measured in centimeters of water pressure (cmH₂O). MIP is a key indicator of ventilatory muscle function and is commonly used in critical care, pulmonary rehabilitation, and neuromuscular disease assessment.
Measured: Immediately after ICU discharge and 0, 3, and 6 months after discharge
Grip strength
Grip strength is a simple and reliable measure of overall muscle strength, particularly of the upper extremities. It is commonly used as a proxy for general physical function and is strongly associated with mobility, nutritional status, and overall health outcomes. Lower grip strength has been linked to increased risk of disability, hospitalization, and mortality.
Measured: Immediately after ICU discharge and 0, 3, and 6 months after discharge
Modified 30-second sit-to-stand test
The Modified 30-Second Sit-to-Stand Test (m30STS) is a functional performance test used to assess lower limb muscle strength and endurance. It measures the number of times an individual can rise from a seated to a standing position in 30 seconds. In the modified version, participants are allowed to use their upper limbs (e.g., pushing off from the chair or armrests) to complete the movement, making it more suitable for frail or physically limited individuals, such as older adults or ICU survivors.
Measured: Immediately after ICU discharge and 0, 3, and 6 months after discharge
Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) is a brief, standardized screening tool designed to detect mild cognitive impairment. It evaluates multiple cognitive domains, including attention, executive function, memory, language, visuospatial ability, abstract thinking, calculation, and orientation. The test is scored out of 30 points, with a score of 26 or above generally considered normal.
Measured: Immediately after ICU discharge and 0, 3, and 6 months after discharge
Confusion assessment methods
The Confusion Assessment Method (CAM) is a widely used, validated tool for the detection of delirium in clinical settings. It allows non-psychiatric clinicians to identify delirium quickly and accurately based on four key diagnostic features: (1) Acute onset and fluctuating course; (2) Inattention; (3) Disorganized thinking; (4) Altered level of consciousness. A diagnosis of delirium using CAM requires the presence of features 1 and 2, plus either feature 3 or 4.
Measured: Immediately after ICU discharge and 0, 3, and 6 months after discharge
Body weight
Body weight refers to the total mass of an individual and is typically measured in kilograms (kg) using a calibrated digital or mechanical scale. It is a key parameter in clinical assessments, nutritional evaluations, and outcome monitoring.
Measured: Immediately after ICU discharge and 0, 1, 2, 3, 4, 5, and 6 months after discharge
Calf circumference
Calf circumference is a simple and non-invasive anthropometric measurement used to assess muscle mass and nutritional status, particularly in older adults. Calf circumference was measured at the widest point of the non-dominant leg using a flexible, non-elastic tape measure, with participants in a seated position and knees at 90 degrees. Measurements were recorded to the nearest 0.1 cm. Cut-off values of <34 cm for men and <33 cm for women were used to identify low muscle mass, according to the AWGS 2019 criteria.
Measured: Immediately after ICU discharge and 0, 1, 2, 3, 4, 5, and 6 months after discharge
Maslach Burnout Inventory - Human Services Survey (MBI-HSS)
The MBI-HSS is a widely used psychological assessment tool designed to measure burnout specifically in professionals working in human services and healthcare, such as nurses, doctors, social workers, and therapists. The survey consists of 22 items (questions). It measures three key dimensions of burnout: (1)Emotional Exhaustion; (2)Depersonalization; (3)Personal Accomplishment. Respondents rate the frequency of experiencing each feeling or attitude on a 7-point Likert scale ranging from 0 (never) to 6 (every day). Higher scores in Emotional Exhaustion and Depersonalization, along with lower scores in Personal Accomplishment, indicate greater levels of burnout.
Measured: 0, 6, 12, 18, and 24 months after I-CARE program start
Intention to leave
Intention to leave is measured by the level of agreement with the following three statements: (1) I plan to leave my job within the next year; (2) I am actively looking for other job opportunities; (3) I want to continue working in this job. Nurses rate these statements using a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). Higher scores on the first and second statements, as well as lower scores on the third statement, indicate a higher intention to leave.
Measured: 0, 6, 12, 18, and 24 months after I-CARE program start
Mortality rate
Mortality rate is a statistical measure that represents the number of deaths in a specific population during a given period of time.
Measured: 1, 2, 3, 4, 5, and 6 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start3 Nov 2025
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU SurvivorsStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997822
- Sponsor's protocol ID
- 202502049RINA
- Acronym
- iCARE
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share the individual participant data because sharing such data requires explicit permission from our study participants to ensure their privacy and confidentiality. Additionally, there are ethical and legal considerations regarding data protection that must be strictly followed. At this time, we prioritize safeguarding participant information and complying with applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Critical Illness Aftercare and Recovery Enhancement (I-CARE) Program
- ClinicalTrials.gov ID
- NCT06997822
- Acronym / sponsor ID
- iCARE / 202502049RINA
- Conditions
- ICU Survivors
- Keywords
- ICU survivors, Physical function, Cognitive, Weight loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 May 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.
This study aims to investigate the effects of the Integrated Critical Illness Aftercare and Recovery Enhancement (I-CARE) program on reducing healthcare burden and improving functional outcomes in ICU survivors. The I-CARE program combines remote support via LINE Bot Care with in-person post-ICU recovery clinic visits. The study will assess whether this integrated care model reduces unplanned hospital readmissions and emergency department visits within six months after discharge, and improves physical and cognitive outcomes at 3 and 6 months post-discharge. Additionally, the study will evaluate the impact of a built-in patient-nurse interaction feature on ICU nurses' burnout and intention to leave, measured every six months over a two-year period.
Detailed description
This randomized clinical trial is designed to evaluate the effectiveness of the Integrated Critical Illness Aftercare and Recovery Enhancement (I-CARE) program for survivors of critical illness discharged from the intensive care unit (ICU). The I-CARE program integrates a LINE Bot-based remote monitoring and support system with structured, in-person post-ICU recovery clinic visits. The primary objective is to determine whether this comprehensive care model can reduce the incidence of unplanned hospital readmissions and emergency department visits within six months after hospital discharge.
Secondary outcomes focus on functional recovery and include assessments of physical mobility (e.g., ability to transition from sit to stand), inspiratory muscle strength, body weight changes, presence of dysphagia, and cognitive function at 3 and 6 months post-discharge.
In addition, the LINE Bot Care system incorporates an interactive feature titled "Thanks to Nurses," which enables ICU survivors to share personal reflections, such as short messages, photos, diary entries, stickers, and audio clips, with their ICU care team. This bidirectional communication channel is intended to enhance emotional support and foster a sense of connection between patients and healthcare providers. The study will evaluate the impact of this feature on ICU nurses' professional well-being, specifically measuring levels of burnout and intention to leave the profession at 6, 12, 18, and 24 months after implementation, using a pre-post intervention design.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LINE Bot-Based Remote Care Combined with In-Person Post-ICU Clinic | Experimental | Behavioral: LINE Bot-Based Remote Care Combined with In-Person Post-ICU ClinicLINE Bot-Based Remote Care includes instructional videos for basic mobility skills, recommended exercise practices, cognitive training, and nutritional education. In addition, survivors can report their signs and symptoms to request relevant educational content. At 3 months, participants will attend a post-ICU clinic for comprehensive assessment, necessary interventions, and care transition planning. |
| Non-Interactive LINE Bot + Assessment-Only Clinic | No intervention | –Participants in the control group will be invited to join an official LINE chat, which will not provide any interventions or educational content. They will, however, receive a post-ICU assessment clinic visit at the 3-month follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ICU survivors who had experienced endotracheal intubation and mechanical ventilation treatment.
Key exclusion criteria (4 listed)
- ICU survivors who are unable to walk independently before admission
- ICU survivors who are unable to receive assessment (e.g., dementia or mental retardation)
- ICU survivors who don't have a smartphone.
- ICU survivors were discharged to institutional care facilities
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 |
|---|---|---|
| LINE Bot-Based Remote Care Combined with In-Person Post-ICU ClinicParticipants in this group will receive the I-CARE intervention, which includes two components: (1) a LINE Bot-based remote care system providing scheduled health education, functional assessments, and reminders tailored to ICU survivors, and (2) structured in-person visits to a post-ICU recovery clinic, where multidisciplinary professionals provide follow-up assessments and individualized rehabilitation guidance. The LINE Bot also features an interactive module ("Thanks to Nurses") that allows patients to send messages, images, or audio clips to their ICU care team, with optional reciprocal feedback. The intervention will be delivered for up to 6 months following hospital discharge. | Behavioural | LINE Bot-Based Remote Care Combined with In-Person Post-ICU Clinic |
Primary outcome
Incidence of unplanned hospital readmissions
Time frame: 1, 2, 3, 4, 5, and 6 months after discharge
Incidence of emergency department visits
Time frame: 1, 2, 3, 4, 5, and 6 months after discharge
11 secondary outcomes
Barthel Index
Time frame: Immediately after ICU discharge and 0, 3, and 6 months after discharge
Maximal inspiratory pressure
Time frame: Immediately after ICU discharge and 0, 3, and 6 months after discharge
Grip strength
Time frame: Immediately after ICU discharge and 0, 3, and 6 months after discharge
Modified 30-second sit-to-stand test
Time frame: Immediately after ICU discharge and 0, 3, and 6 months after discharge
Montreal Cognitive Assessment
Time frame: Immediately after ICU discharge and 0, 3, and 6 months after discharge
Confusion assessment methods
Time frame: Immediately after ICU discharge and 0, 3, and 6 months after discharge
Body weight
Time frame: Immediately after ICU discharge and 0, 1, 2, 3, 4, 5, and 6 months after discharge
Calf circumference
Time frame: Immediately after ICU discharge and 0, 1, 2, 3, 4, 5, and 6 months after discharge
Maslach Burnout Inventory - Human Services Survey (MBI-HSS)
Time frame: 0, 6, 12, 18, and 24 months after I-CARE program start
Intention to leave
Time frame: 0, 6, 12, 18, and 24 months after I-CARE program start
Mortality rate
Time frame: 1, 2, 3, 4, 5, and 6 months after discharge
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 3 Dec 2025.
- Individual participant dataSharing planned: No. We do not plan to share the individual participant data because sharing such data requires explicit permission from our study participants to ensure their privacy and confidentiality. Additionally, there are ethical and legal considerations regarding data protection that must be strictly followed. At this time, we prioritize safeguarding participant information and complying with applicable regulations.
Related trials for ICU Survivors
RecruitingObservational study
Long-Term Recovery and Quality of Life in Sepsis Survivors
Sepsis, Long Term Care
Recruiting
Gyrotonic Exercise in Lupus Adolescents Who Survived From Intensive Care
Systemic Lupus Erthematosus, Childhood-onset Systemic Lupus Erythematous
Active, not recruitingObservational study
PICS: Subtitle Cardiac Dysfunction in Older Sepsis Survivors
Sepsis
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Supply Induced Demand in Intensive Care Unit: a Retrospective Trial
Intensive Care (ICU), Intensive Care Unit (ICU) Admission
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LINE Bot-Based Remote Care Combined with In-Person Post-ICU Clinic in people with ICU Survivors, run by National Taiwan University 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 1 inclusion and 4 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 3 Dec 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 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 Cheryl Chia-Hui Chen, PhD ((886) 2-23123456 ext. 288438, cherylchen@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of unplanned hospital readmissions (time frame: 1, 2, 3, 4, 5, and 6 months after discharge). The study lists 2 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 3 Dec 2025.