Family-authored Digital ICU Diary Intervention to Support Bereaved Family Members in Intensive Care Unit: A Pilot Mixed Methods Study (ICU-Diary-HK)
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.
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Hye Ri Choi
- Telefoonnummer: 852-6349-0524
- E-mail: hyeripc@hku.hk
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Interventie
|
From medical consideration of life-sustaining treatment through patient death + 1 month post-death (approximately 4 weeks active writing, then wound down)
Standard care without the digital ICU diary intervention
|
|
Actieve vergelijker: Controle
|
Standard care without the digital ICU diary intervention
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Feasibility of the Digital ICU Diary Intervention
Tijdsspanne: 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.
|
Month 1 and Month 3 after patient's death
|
|
Acceptability of the Digital ICU Diary Intervention
Tijdsspanne: 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.
|
Month 1 and Month 3 after patient's death
|
|
Appropriateness of the Digital ICU Diary Intervention
Tijdsspanne: 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.
|
Month 1 and Month 3 after patient's death
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Post-Traumatic Stress Symptoms as Measured by the Impact of Event Scale-Revised (IES-R)
Tijdsspanne: 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.
|
Baseline, Month 1, and Month 3 after patient's death
|
|
Post-Traumatic Stress Symptoms as Measured by PTSS-14
Tijdsspanne: 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.
|
Baseline, Month 1, and Month 3 after patient's death
|
|
Anxiety as Measured by the Hospital Anxiety and Depression Scale (HADS-A)
Tijdsspanne: 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.
|
Baseline, Month 1, and Month 3 after patient's death
|
|
Depression as Measured by the Hospital Anxiety and Depression Scale (HADS-D)
Tijdsspanne: 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.
|
Baseline, Month 1, and Month 3 after patient's death
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Trauma- en stressorgerelateerde aandoeningen
- Psychische aandoening
- Gedragssymptomen
- Stressstoornissen, Traumatisch
- Gedrag
- Angst stoornissen
- Depressie
- Stressstoornissen, posttraumatisch
- Health Services Administration
- Kwaliteit, toegang en evaluatie van de gezondheidszorg
- Kwaliteit van de gezondheidszorg
- Kwaliteitsindicatoren, gezondheidszorg
- Zorgstandaard
Andere studie-ID-nummers
- HMRF23242771
Plan Individuele Deelnemersgegevens (IPD)
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