Impact of Interactive ICU Diary on Psychological Distress

NCT06512987 | Terminated

• 1 other identifier: N202403088
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the effectiveness of a technology-driven, interactive ICU diary in reducing psychological distress, specifically anxiety, depression, and stress, in ICU patients. A single-blind, parallel-group randomized controlled trial will include 56 conscious ICU patients. The primary outcome measures are the Depression, Anxiety, and Stress Scale-21 (DASS-21) and the EuroQol instrument (EQ-5D), assessed at ICU admission, discharge, and one month post-discharge.

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

• Psychological Distress Levels (DASS-21)

  The primary outcome will be the psychological distress levels measured by the Depression, Anxiety, and Stress Scale-21 (DASS-21). This scale assesses anxiety, depression, and stress in ICU patients through 21 items, each rated from 0 ("Did not apply to me at all - Never") to 3 ("Applied to me very much, or most of the time - Almost always"). The total score for each subscale (DASS-21-Depression, DASS-21-Anxiety, and DASS-21-Stress) ranges from 0 to 21, with higher scores indicating greater emotional distress. The cutoff scores for DASS-21-Depression, DASS-21-Anxiety, and DASS-21-Stress are \>9, \>7, and \>14, respectively.

  7 days after admission and one month post-discharge.

Secondary Outcomes (1)

• Quality of Life (EQ-5D)

  7 days after admission and one month post-discharge.

Study Arms (2)

Interactive ICU Diary Group

EXPERIMENTAL

Patients in this group will use a technology-driven, interactive ICU diary from the first day of ICU admission until discharge. Through the diary platform, patients can share their feelings and needs, while family members can send supportive messages, pictures, and videos. Healthcare providers will use the platform to connect with families and monitor patient conditions. The goal is to reduce psychological distress, specifically anxiety, depression, and stress, during the ICU stay.

Other: technology-driven, interactive ICU diary

routine care

NO INTERVENTION

Patients in this group will receive standard ICU care without the use of the interactive ICU diary.

Interventions

technology-driven, interactive ICU diary OTHER

Through the diary platform, patients can share their feelings and needs, while family members can send supportive messages, pictures, and videos. Healthcare providers will use the platform to connect with families and monitor patient conditions.

Interactive ICU Diary Group

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• Clear consciousness and able to communicate in Mandarin, Taiwanese, or Hakka
• Expected ICU stay of at least 72 hours
• Ability to operate a smart device and use social media applications

You may not qualify if:

• Presence of delirium before joining the study (Intensive Care Delirium Screening Checklist score ≥ 4)
• Physical, auditory, or visual impairments preventing the use of smart devices History of epilepsy, cognitive impairments (e.g., hepatic encephalopathy, dementia), or psychiatric disorders
• Richmond Agitation-Sedation Scale score not between +1 and -1 (indicating excessive sedation or agitation)
• Acute Physiology and Chronic Health Evaluation Score (APACHE-II) \> 25 within the first 24 hours of ICU admission (indicating \> 50% mortality rate)

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University Hospital

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hsiao-Yean Chiu

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 22, 2024
• Study Start: September 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: May 31, 2025
• Last Updated: August 14, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)