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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
  • National Taiwan University Hospital

    Taipei, 10055

    Cheryl Chia-Hui Chen, PhD, 886-2-23123456 ext. 288438, cherylchen@ntu.edu.tw

    Recruiting

Other trials in Taiwan

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 groups in NCT06997822
Study groupRoleWhat they receive
LINE Bot-Based Remote Care Combined with In-Person Post-ICU ClinicExperimentalLINE 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 ClinicNo interventionParticipants 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.

  1. Incidence of unplanned hospital readmissions

    Measured: 1, 2, 3, 4, 5, and 6 months after discharge

  2. Incidence of emergency department visits

    Measured: 1, 2, 3, 4, 5, and 6 months after discharge

Secondary outcomes (11)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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.

  1. First posted30 May 2025
  2. Study start3 Nov 2025
  3. Primary completion31 Jul 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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)
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.

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.

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