Integrated Recovery Program for Critical Illness

NCT06997822 | Recruiting

• 1 other identifier: 202502049RINA
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

ICU Survivors

Keywords

ICU survivors; Physical function; Cognitive; Weight loss

Outcome Measures

Primary Outcomes (2)

• Incidence of unplanned hospital readmissions

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

• Incidence of emergency department visits

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

Secondary Outcomes (11)

• 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

• 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

Study Arms (2)

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.

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.

Interventions

LINE Bot-Based Remote Care Combined with In-Person Post-ICU Clinic BEHAVIORAL

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.

LINE Bot-Based Remote Care Combined with In-Person Post-ICU Clinic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10055, Taiwan

RECRUITING

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Cheryl Chia-Hui Chen, PhD

CONTACT

(886) 2-23123456; cherylchen@ntu.edu.tw

Kuo-Jen Hsu, PhD

CONTACT

+886-2-23123456; mike19940810@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 30, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)