Impact of Interactive ICU Diary on Psychological Distress

Effects of Technology-Driven, Interactive Intensive Care Unit Diary on Psychological Distress in Patients Requiring Intensive Care: A Randomized Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Critical Illness
• Intervention / Treatment: Other: technology-driven, interactive ICU diary

Detailed Description

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, randomly assigned to either the interactive diary group or the standard care group. The interactive diary allows patients to share their feelings and needs via a platform, while family members can send supportive messages, pictures, and videos. Healthcare providers can connect with families and monitor patient conditions through the platform. 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. The expected results indicate that the interactive diary will significantly alleviate psychological distress during the ICU stay and improve post-discharge quality of life, providing valuable insights into enhancing the mental health and overall well-being of ICU patients.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Taipei Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interactive ICU Diary Group; 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; 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.
No Intervention: routine care; Patients in this group will receive standard ICU care without the use of the interactive ICU diary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life (EQ-5D)	The secondary outcome will be the quality of life measured by the EuroQol instrument (EQ-5D-3L). This instrument includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored with three levels: no problems (1), some problems (2), and extreme problems (3). The EQ-5D index score, derived using a pre-established conversion formula from neighboring countries like Japan or the UK, ranges from 0 to 1, with higher scores indicating better quality of life. Additionally, the EQ-VAS, a visual analogue scale from 0 (worst imaginable health) to 100 (best imaginable health), will be used to assess self-perceived health status. The EQ-VAS score will be recorded directly by marking a vertical scale.	7 days after admission and one month post-discharge.

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Investigators: Principal Investigator: Hsiao-Yean Chiu, Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: N202403088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No