[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653410":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":33,"armGroups":42,"interventions":53,"overallOfficials":33,"centralContacts":63,"locations":33,"responsibleParty":69,"collaborators":33,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":33,"enrollmentInfo":83,"targetDuration":33,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":96,"whyStopped":33,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":33},{"fullName":5,"class":6},"The University of Hong Kong","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":33},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"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",{"measure":14,"description":15,"timeFrame":12},"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.",{"measure":17,"description":18,"timeFrame":12},"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.",[20,24,27,30],{"measure":21,"description":22,"timeFrame":23},"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.","Baseline, Month 1, and Month 3 after patient's death",{"measure":25,"description":26,"timeFrame":23},"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.",{"measure":28,"description":29,"timeFrame":23},"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.",{"measure":31,"description":32,"timeFrame":23},"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.",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"RANDOMIZED","PARALLEL","HEALTH_SERVICES_RESEARCH",{"masking":39,"maskingDescription":33,"whoMasked":40},"SINGLE",[41],"OUTCOMES_ASSESSOR",[43,49],{"label":44,"type":45,"description":33,"interventionNames":46},"Intervention","EXPERIMENTAL",[47,48],"Behavioral: Family-authored Digital ICU Diary Intervention","Other: Standard Care",{"label":50,"type":51,"description":33,"interventionNames":52},"Control","ACTIVE_COMPARATOR",[48],[54,59],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":33},"BEHAVIORAL","Family-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)",[44],{"type":6,"name":60,"description":61,"armGroupLabels":62,"otherNames":33},"Standard Care","Standard care without the digital ICU diary intervention",[50,44],[64],{"name":65,"role":66,"phone":67,"phoneExt":33,"email":68},"Hye Ri Choi","CONTACT","852-6349-0524","hyeripc@hku.hk",{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Choi, Hye Ri","Research Assistant Professor","100653410","family-authored-digital-icu-diary-intervention-to-support-bereaved-family-members-in-intensive-care-unit-a-pilot-mixed-methods-study-100653410",false,"NCT07788768","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","ICU-Diary-HK","Inclusion Criteria:\n\n* One family member (closest to patient: spouse, grown child, or parent) of adult ICU patients whose treatment is considered life-sustaining\n* Patient admitted to adult ICU for minimum 48 hours\n* Patient dies in adult ICU without transfer to other inpatient units\n* Able to read, write and communicate effectively in Chinese or English\n\nExclusion Criteria:\n\n* Currently diagnosed with psychiatric disease and taking psychotropic medication\n* Currently participating in any psychological intervention\n* Cognitive impairment","ALL","18 Years",{"count":84,"type":85},40,"ESTIMATED","INTERVENTIONAL",[88],"NA","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.\n\nHypothesis: 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.\n\nDesign 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.\n\nInstruments: 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).\n\nIntervention: 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.\n\nMain Outcome Measures: Primary: recruitment rate, retention rate, compliance, feasibility, acceptability and appropriateness. Secondary: symptoms of PTSD, anxiety and depression.\n\nData Analysis: Descriptive statistics for feasibility outcomes; repeated measures ANOVA and linear mixed effects models for psychological outcomes; thematic analysis for qualitative data.",[91],"Bereavement",[93,94,95],"Stress disorder, Post-traumatic","Anxiety","Depression","NOT_YET_RECRUITING","2026-08-24",{"date":99,"type":100},"2026-08-26","ACTUAL",{"date":102,"type":85},"2026-09-01",{"date":104,"type":85},"2029-08-31",{"name":5,"class":6}]