Critical IllnessNCT06512987
Impact of Interactive ICU Diary on Psychological Distress
A study testing technology-driven, interactive ICU diary in people with Critical Illness, run by Taipei Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- technology-driven, interactive ICU diary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2024to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Critical Illness
- Being tested
- technology-driven, interactive ICU diary
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
technology-driven, interactive ICU diaryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days after admission and one month post-discharge.
Secondary outcomes (1)
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.
Measured: 7 days after admission and one month post-discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Sep 2024
- Primary completion30 Apr 2025
- Study completion31 May 2025
Why it stopped: The study was terminated due to insufficient staffing, which impacted the ability to continue subject enrollment and study operations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsiao-Yean Chiu, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512987
- Sponsor's protocol ID
- N202403088
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Technology-Driven, Interactive Intensive Care Unit Diary on Psychological Distress in Patients Requiring Intensive Care: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06512987
- Acronym / sponsor ID
- N202403088
- Conditions
- Critical Illness
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to insufficient staffing, which impacted the ability to continue subject enrollment and study operations.
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive ICU Diary Group | Experimental | Other: technology-driven, interactive ICU diaryPatients 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. |
| routine care | No intervention | –Patients in this group will receive standard ICU care without the use of the interactive ICU diary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| technology-driven, interactive ICU diaryThrough 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. | Other | Interactive ICU Diary Group |
Primary outcome
Psychological Distress Levels (DASS-21)
Time frame: 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.
1 secondary outcome
Quality of Life (EQ-5D)
Time frame: 7 days after admission and one month post-discharge.
Results and safety
The study was stopped early (reason given: The study was terminated due to insufficient staffing, which impacted the ability to continue subject enrollment and study operations.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsiao-Yean Chiu principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing technology-driven, interactive ICU diary in people with Critical Illness, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated due to insufficient staffing, which impacted the ability to continue subject enrollment and study operations.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological Distress Levels (DASS-21) (time frame: 7 days after admission and one month post-discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.