Impact of Interactive ICU Diary on Psychological Distress

Not Applicable

Not yet recruiting

• Conditions: Critical Illness
• Interventions: Other: technology-driven, interactive ICU diary

• Registration Number: NCT06512987
• Lead Sponsor: Taipei Medical University

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.

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 Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-16
• Last Update Submitted: 2024-07-16
• Study First Posted: 2024-07-22
• Last Update Posted: 2024-07-22
• Study Start: 2024-08-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interactive ICU Diary Group	technology-driven, interactive ICU diary	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.

Primary Outcome Measures

Name	Time	Method
Psychological Distress Levels (DASS-21)	7 days after admission and one month post-discharge.	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.

Secondary Outcome Measures

Name	Time	Method
Quality of Life (EQ-5D)	7 days after admission and one month post-discharge.	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.

Trial Locations

Locations (1)

Taipei Medical University Hospital; 🇨🇳 Taipei, Taiwan