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

NCT07788768 | Not Yet Recruiting

• 1 other identifier: HMRF23242771
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bereavement

Keywords

Stress disorder, Post-traumatic; Anxiety; Depression

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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)

  Baseline, Month 1, and Month 3 after patient's death

• Post-Traumatic Stress Symptoms as Measured by PTSS-14

  Baseline, Month 1, and Month 3 after patient's death

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

  Baseline, Month 1, and Month 3 after patient's death

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

  Baseline, Month 1, and Month 3 after patient's death

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral: Family-authored Digital ICU Diary Intervention; Other: Standard Care

Control

ACTIVE COMPARATOR

Other: Standard Care

Interventions

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)

Intervention

Standard Care OTHER

Standard care without the digital ICU diary intervention

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Anxiety Disorders; Depression

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Hye Ri Choi

CONTACT

852-6349-0524; hyeripc@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: August 26, 2026

Record last verified: 2026-08