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NCT Number: NCT07788768

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

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.

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Key information

Conditions

Bereavement Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Family-authored Digital ICU Diary Intervention

Behavioral

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

Standard care

Other

Standard care without the digital ICU diary intervention

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

    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.

  2. Post-Traumatic Stress Symptoms as Measured by PTSS-14

    Time frame: Baseline, Month 1, and Month 3 after patient's death

    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.

  3. Anxiety as Measured by the Hospital Anxiety and Depression Scale (HADS-A)

    Time frame: Baseline, Month 1, and Month 3 after patient's death

    HADS anxiety subscale, 7 items scored 0-3 each. Subscale score ranges from 0 to 21. Higher scores indicate greater severity of anxiety symptoms.

  4. Depression as Measured by the Hospital Anxiety and Depression Scale (HADS-D)

    Time frame: Baseline, Month 1, and Month 3 after patient's death

    HADS depression subscale, 7 items scored 0-3 each. Subscale score ranges from 0 to 21. Higher scores indicate greater severity of depression symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Hye Ri Choi

CONTACT

[email protected]

852-6349-0524

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study 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

Acronym: ICU-Diary-HK

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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