Clinical trial NCT06512987: Impact of Interactive ICU Diary on Psychological Distress
Official title: Effects of Technology-Driven, Interactive Intensive Care Unit Diary on Psychological Distress in Patients Requiring Intensive Care: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Critical Illness
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Psychological Distress Levels (DASS-21)
timeFrame: 7 days after admission and one month post-discharge.
Secondary outcomes:
measure: Quality of Life (EQ-5D)
timeFrame: 7 days after admission and one month post-discharge.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
affiliation: Taipei Medical University
name: Hsiao-Yean Chiu
role: PRINCIPAL_INVESTIGATOR
References: