BereavementICU-Diary-HKNCT07788768
Family-authored Digital ICU Diary Intervention to Support Bereaved Family Members in Intensive Care Unit: A Pilot Mixed Methods Study
A study testing Family-authored Digital ICU Diary Intervention in people with Bereavement, run by The University of Hong Kong.
Trial summary
Objectives: To assess the feasibility, acceptability and appropriateness of a family-authored digital ICU diary intervention for bereaved family members in Hong Kong ICUs, and to explore family members' experiences of writing digital diaries during and following patient death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bereavement
- What is being tested?
- Family-authored Digital ICU Diary Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- One family member (closest to patient: spouse, grown child, or parent) of adult ICU patients whose treatment is considered life-sustaining
- Patient admitted to adult ICU for minimum 48 hours
- Patient dies in adult ICU without transfer to other inpatient units
- Able to read, write and communicate effectively in Chinese or English
Who cannot join
- Currently diagnosed with psychiatric disease and taking psychotropic medication
- Currently participating in any psychological intervention
- Cognitive impairment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility, Acceptability and Efficacy of a Family-authored Digital ICU Diary Intervention for Bereaved Family Members in Hong Kong Intensive Care Units: A Pilot Randomised Controlled Trial With Qualitative Process Evaluation
Objectives: To assess the feasibility, acceptability and appropriateness of a family-authored digital ICU diary intervention for bereaved family members in Hong Kong ICUs, and to explore family members' experiences of writing digital diaries during and following patient death.
Hypothesis: The ICU digital diary intervention will prove feasible, acceptable and potentially efficacious in reducing bereaved family members' PTSD, anxiety and depression at 1 and 3 months post-patient death compared with baseline measurements.
Read more
Design and Subjects: A two-arm, assessor-blind pilot randomised controlled trial with subsequent qualitative process evaluation. Forty family members of ICU patients receiving life-sustaining treatment will be recruited from three Hong Kong public hospitals and randomised 1:1 to intervention or control groups.
Instruments: Feasibility of Intervention Measure (FIM), Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), Impact of Event Scale-Revised (IES-R), Posttraumatic Stress Syndrome-14 (PTSS-14) and Hospital Anxiety and Depression Scale (HADS).
Intervention: Family-authored digital ICU diary via WhatsApp, commencing when a patient's treatment is deemed life-sustaining, continuing through death and a one-month bereavement period.
Main Outcome Measures: Primary: recruitment rate, retention rate, compliance, feasibility, acceptability and appropriateness. Secondary: symptoms of PTSD, anxiety and depression.
Data Analysis: Descriptive statistics for feasibility outcomes; repeated measures ANOVA and linear mixed effects models for psychological outcomes; thematic analysis for qualitative data.
- Conditions
- Bereavement
- Being tested
- Family-authored Digital ICU Diary Intervention, Standard Care
- Keywords
- Stress disorder, Post-traumatic, Anxiety, Depression
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-authored Digital ICU Diary InterventionBehavioural
From medical consideration of life-sustaining treatment through patient death + 1 month post-death (approximately 4 weeks active writing, then wound down)
Standard CareOther
Standard care without the digital ICU diary intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Family-authored Digital ICU Diary Intervention; Other: Standard Care |
| Control | Active comparator | Not described Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Digital ICU Diary Intervention
Feasibility assessed using the Feasibility of Intervention Measure (FIM), a 4-item, 5-point Likert scale (1=Completely disagree to 5=Completely agree). Higher scores indicate greater perceived feasibility.
Measured: Month 1 and Month 3 after patient's death
Acceptability of the Digital ICU Diary Intervention
Acceptability assessed using the Acceptability of Intervention Measure (AIM), a 4-item, 5-point Likert scale (1=Completely disagree to 5=Completely agree). Higher scores indicate greater perceived acceptability.
Measured: Month 1 and Month 3 after patient's death
Appropriateness of the Digital ICU Diary Intervention
Appropriateness assessed using the Intervention Appropriateness Measure (IAM), a 4-item, 5-point Likert scale (1=Completely disagree to 5=Completely agree). Higher scores indicate greater perceived appropriateness.
Measured: Month 1 and Month 3 after patient's death
Secondary outcomes (4)
Post-Traumatic Stress Symptoms as Measured by the Impact of Event Scale-Revised (IES-R)
IES-R, a 22-item self-report scale rated on a 5-point scale (0=not at all to 4=extremely). Total score ranges from 0 to 88. Higher scores indicate greater severity of post-traumatic stress symptoms.
Measured: Baseline, Month 1, and Month 3 after patient's death
Post-Traumatic Stress Symptoms as Measured by PTSS-14
Posttraumatic Stress Syndrome-14 (PTSS-14), a 14-item self-report scale rated on a 7-point Likert scale (1=never to 7=always). Total score ranges from 14 to 98. Higher scores indicate greater severity of post-traumatic stress symptoms.
Measured: Baseline, Month 1, and Month 3 after patient's death
Anxiety as Measured by the Hospital Anxiety and Depression Scale (HADS-A)
HADS anxiety subscale, 7 items scored 0-3 each. Subscale score ranges from 0 to 21. Higher scores indicate greater severity of anxiety symptoms.
Measured: Baseline, Month 1, and Month 3 after patient's death
Depression as Measured by the Hospital Anxiety and Depression Scale (HADS-D)
HADS depression subscale, 7 items scored 0-3 each. Subscale score ranges from 0 to 21. Higher scores indicate greater severity of depression symptoms.
Measured: Baseline, Month 1, and Month 3 after patient's death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion28 Feb 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BereavementStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Choi, Hye Ri, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788768
- Sponsor's protocol ID
- HMRF23242771
- Acronym
- ICU-Diary-HK
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability and Efficacy of a Family-authored Digital ICU Diary Intervention for Bereaved Family Members in Hong Kong Intensive Care Units: A Pilot Randomised Controlled Trial With Qualitative Process Evaluation
- ClinicalTrials.gov ID
- NCT07788768
- Acronym / sponsor ID
- ICU-Diary-HK / HMRF23242771
- Conditions
- Bereavement
- Keywords
- Stress disorder, Post-traumatic, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 26 Aug 2026 (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.
Objectives: To assess the feasibility, acceptability and appropriateness of a family-authored digital ICU diary intervention for bereaved family members in Hong Kong ICUs, and to explore family members' experiences of writing digital diaries during and following patient death.
Hypothesis: The ICU digital diary intervention will prove feasible, acceptable and potentially efficacious in reducing bereaved family members' PTSD, anxiety and depression at 1 and 3 months post-patient death compared with baseline measurements.
Design and Subjects: A two-arm, assessor-blind pilot randomised controlled trial with subsequent qualitative process evaluation. Forty family members of ICU patients receiving life-sustaining treatment will be recruited from three Hong Kong public hospitals and randomised 1:1 to intervention or control groups.
Instruments: Feasibility of Intervention Measure (FIM), Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), Impact of Event Scale-Revised (IES-R), Posttraumatic Stress Syndrome-14 (PTSS-14) and Hospital Anxiety and Depression Scale (HADS).
Intervention: Family-authored digital ICU diary via WhatsApp, commencing when a patient's treatment is deemed life-sustaining, continuing through death and a one-month bereavement period.
Main Outcome Measures: Primary: recruitment rate, retention rate, compliance, feasibility, acceptability and appropriateness. Secondary: symptoms of PTSD, anxiety and depression.
Data Analysis: Descriptive statistics for feasibility outcomes; repeated measures ANOVA and linear mixed effects models for psychological outcomes; thematic analysis for qualitative data.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Family-authored Digital ICU Diary Intervention, Other: Standard Care |
| Control | Active comparator | Other: Standard Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- One family member (closest to patient: spouse, grown child, or parent) of adult ICU patients whose treatment is considered life-sustaining
- Patient admitted to adult ICU for minimum 48 hours
- Patient dies in adult ICU without transfer to other inpatient units
- Able to read, write and communicate effectively in Chinese or English
Key exclusion criteria (3 listed)
- Currently diagnosed with psychiatric disease and taking psychotropic medication
- Currently participating in any psychological intervention
- Cognitive impairment
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 |
|---|---|---|
| Family-authored Digital ICU Diary InterventionFrom medical consideration of life-sustaining treatment through patient death + 1 month post-death (approximately 4 weeks active writing, then wound down) | Behavioural | Intervention |
| Standard CareStandard care without the digital ICU diary intervention | Other | Control, Intervention |
Primary outcome
Feasibility of the Digital ICU Diary Intervention
Time frame: Month 1 and Month 3 after patient's death
Feasibility assessed using the Feasibility of Intervention Measure (FIM), a 4-item, 5-point Likert scale (1=Completely disagree to 5=Completely agree). Higher scores indicate greater perceived feasibility.
Acceptability of the Digital ICU Diary Intervention
Time frame: Month 1 and Month 3 after patient's death
Acceptability assessed using the Acceptability of Intervention Measure (AIM), a 4-item, 5-point Likert scale (1=Completely disagree to 5=Completely agree). Higher scores indicate greater perceived acceptability.
Appropriateness of the Digital ICU Diary Intervention
Time frame: Month 1 and Month 3 after patient's death
Appropriateness assessed using the Intervention Appropriateness Measure (IAM), a 4-item, 5-point Likert scale (1=Completely disagree to 5=Completely agree). Higher scores indicate greater perceived appropriateness.
4 secondary outcomes
Post-Traumatic Stress Symptoms as Measured by the Impact of Event Scale-Revised (IES-R)
Time frame: Baseline, Month 1, and Month 3 after patient's death
Post-Traumatic Stress Symptoms as Measured by PTSS-14
Time frame: Baseline, Month 1, and Month 3 after patient's death
Anxiety as Measured by the Hospital Anxiety and Depression Scale (HADS-A)
Time frame: Baseline, Month 1, and Month 3 after patient's death
Depression as Measured by the Hospital Anxiety and Depression Scale (HADS-D)
Time frame: Baseline, Month 1, and Month 3 after patient's death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Family-authored Digital ICU Diary Intervention in people with Bereavement, run by The University of Hong Kong.
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 3 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: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hye Ri Choi (852-6349-0524, hyeripc@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Digital ICU Diary Intervention (time frame: Month 1 and Month 3 after patient's death). The study lists 3 primary outcomes in all. 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 26 Aug 2026.