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Clinical Trials/NCT06997822
NCT06997822RecruitingNot Applicable

Integrated Critical Illness Aftercare and Recovery Enhancement (I-CARE) Program

National Taiwan University Hospital1 site in 1 country240 target enrollmentStarted: November 3, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
240
Locations
1
Primary Endpoint
Incidence of unplanned hospital readmissions

Study Overview

Brief 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. 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •ICU survivors who had experienced endotracheal intubation and mechanical ventilation treatment.

Exclusion Criteria

  • •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

Arms & Interventions

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.

Intervention: LINE Bot-Based Remote Care Combined with In-Person Post-ICU Clinic (Behavioral)

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Barthel Index(Immediately after ICU discharge and 0, 3, and 6 months after discharge)
  • Maximal inspiratory pressure(Immediately after ICU discharge and 0, 3, and 6 months after discharge)
  • Grip strength(Immediately after ICU discharge and 0, 3, and 6 months after discharge)
  • Confusion assessment methods(Immediately after ICU discharge and 0, 3, and 6 months after discharge)
  • Body weight(Immediately after ICU discharge and 0, 1, 2, 3, 4, 5, and 6 months after discharge)
  • Calf circumference(Immediately after ICU discharge and 0, 1, 2, 3, 4, 5, and 6 months after discharge)
  • Modified 30-second sit-to-stand test(Immediately after ICU discharge and 0, 3, and 6 months after discharge)
  • Montreal Cognitive Assessment(Immediately after ICU discharge and 0, 3, and 6 months after discharge)
  • Maslach Burnout Inventory - Human Services Survey (MBI-HSS)(0, 6, 12, 18, and 24 months after I-CARE program start)
  • Intention to leave(0, 6, 12, 18, and 24 months after I-CARE program start)
  • Mortality rate(1, 2, 3, 4, 5, and 6 months after discharge)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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