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The study was terminated due to insufficient staffing, which impacted the ability to continue subject enrollment and study operations.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| routine care | No Intervention | Patients in this group will receive standard ICU care without the use of the interactive ICU diary. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hsiao-Yean Chiu | Taipei Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University Hospital | Taipei | 110 | Taiwan |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 7 days after admission and one month post-discharge. |