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Family-authored Digital ICU Diary Intervention to Support Bereaved Family Members in Intensive Care Unit: A Pilot Mixed Methods Study

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07788768
Acronym
ICU-Diary-HK
Enrollment
40
Registered
2026-08-26
Start date
2026-09-01
Completion date
2029-08-31
Last updated
2026-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bereavement

Keywords

Stress disorder, Post-traumatic, Anxiety, Depression

Brief 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. 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.

Interventions

BEHAVIORALFamily-authored Digital ICU Diary Intervention

From medical consideration of life-sustaining treatment through patient death + 1 month post-death (approximately 4 weeks active writing, then wound down)

OTHERStandard Care

Standard care without the digital ICU diary intervention

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Currently diagnosed with psychiatric disease and taking psychotropic medication * Currently participating in any psychological intervention * Cognitive impairment

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of the Digital ICU Diary InterventionMonth 1 and Month 3 after patient's deathFeasibility 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 InterventionMonth 1 and Month 3 after patient's deathAcceptability 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 InterventionMonth 1 and Month 3 after patient's deathAppropriateness 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.

Secondary

MeasureTime frameDescription
Post-Traumatic Stress Symptoms as Measured by the Impact of Event Scale-Revised (IES-R)Baseline, Month 1, and Month 3 after patient's deathIES-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.
Post-Traumatic Stress Symptoms as Measured by PTSS-14Baseline, Month 1, and Month 3 after patient's deathPosttraumatic 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.
Anxiety as Measured by the Hospital Anxiety and Depression Scale (HADS-A)Baseline, Month 1, and Month 3 after patient's deathHADS anxiety subscale, 7 items scored 0-3 each. Subscale score ranges from 0 to 21. Higher scores indicate greater severity of anxiety symptoms.
Depression as Measured by the Hospital Anxiety and Depression Scale (HADS-D)Baseline, Month 1, and Month 3 after patient's deathHADS depression subscale, 7 items scored 0-3 each. Subscale score ranges from 0 to 21. Higher scores indicate greater severity of depression symptoms.

Contacts

CONTACTHye Ri Choi
hyeripc@hku.hk852-6349-0524

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 27, 2026