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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Hye Ri Choi
- 電話番号：852-6349-0524
- メール：hyeripc@hku.hk
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：介入
|
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
|
|
アクティブコンパレータ：コントロール
|
Standard care without the digital ICU diary intervention
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Feasibility of the Digital ICU Diary Intervention
時間枠：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
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Post-Traumatic Stress Symptoms as Measured by the Impact of Event Scale-Revised (IES-R)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- HMRF23242771
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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