Protocol for a Hybrid Implementation-effectiveness Feasibility Study of a Transdisciplinary ICU-to-home Recovery Model (THRIVE@TTSH)
Transition Support and Holistic Recovery Interventions for Vulnerable Ex-ICU Patients @ Tan Tock Seng Hospital (THRIVE@TTSH): Protocol for a Hybrid Implementation-effectiveness Feasibility Study of a Transdisciplinary ICU-to-home Recovery Model
This is a prospective, single-centre study which will recruit 50 adult ICU survivors over 12 months. Assessments will occur during hospitalisation and at Months 3 and 6 after hospital discharge, with a final phone follow-up at Month 12. There will be volunteer-supported home visits for 6 months post hospital discharge.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
This is a prospective, single-centre hybrid implementation-effectiveness feasibility study which will recruit 50 adult ICU survivors over 12 months. Assessments will occur during hospitalisation and at Months 3 and 6 after hospital discharge, with a final phone follow-up at Month 12. There will be volunteer-supported home visits for 6 months post hospital discharge. The primary feasibility outcome is the proportion of enrolled participants alive at Month 6 who complete outcome assessment.
Secondary implementation outcomes include recruitment, retention, home-visit completion and acceptability. Exploratory outcomes include Post ICU Syndrome (PICS) recovery trajectories, healthcare utilisation and mortality through 12 months post discharge from the acute hospital.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Yie Hui Lau
- 電話番号：+65 63577771
- メール：yie.hui.lau@nhghealth.com.sg
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion criteria
- Received invasive mechanical ventilation for ≥ 48 hours;
- Aged ≥ 21 years;
- Premorbidly independent in basic activities of daily living;
- Had decision-making capacity before the acute illness and are expected to regain capacity before acute hospital discharge;
- Have evidence of new or worsening physical, cognitive, mental-health or swallowing impairment compared with their premorbid state; and
- Are ultimately planned for discharge to the community/home setting. Worsening in PICS domains is defined as an increase in CFS score compared with premorbid status, newly acquired swallowing dysfunction, new cognitive impairment after exclusion of delirium, suspected anxiety or depressive symptoms, or clinically important deterioration in physical or functional performance.
Mental-health screening will not be interpreted as diagnostic criteria for anxiety or depressive disorders.
Exclusion criteria
- cognitive or psychiatric impairment that precludes meaningful participation in the study;
- are already enrolled in, or expected to enter, a structured follow-up pathway that substantially duplicates the rehabilitation intervention; or
- have treatment primarily directed towards palliation or end-of-life care
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Single arm feasibility study
|
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
completion of the Month-6 PICS physical assessment
時間枠：From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment
|
Physical :5 Times Sit-to-Stand Time in seconds required to complete five sit-to-stand repetitions. Values will be summarized at each assessment time point and change over time described. |
From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment
|
|
completion of the Month 6 physical domain assessment
時間枠：From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment
|
Handgrip strength measured in kilograms using a standardized dynamometer procedure. Values will be summarized at each assessment time point and longitudinal change described. |
From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment
|
|
completion of Month 6 Cognitive domain assessment
時間枠：From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment Time points: (Hospital discharge, 3, 6 month post hospital discharge)
|
Cognitive function measured using the Mini Mental State examination. Scores will be summarized at each assessment time point and longitudinal change described. MoCA may be used where clinically indicated and will be reported separately rather than treated as equivalent to MMSE. |
From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment Time points: (Hospital discharge, 3, 6 month post hospital discharge)
|
|
Completion of Month 6 Mental Domain assessment
時間枠：From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment
|
Depressive symptoms screened using the Patient Health Questionnaire-9(PHQ-9). Total scores will be summarized at each assessment time point |
From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment
|
|
Completion of Month 6 Mental Domain Assessment
時間枠：From recruitment to 6 months post hospital discharge, or death by any cause, up toFrom recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment
|
Anxiety symptoms screened using the GAD-7. Total scores will be summarized at each assessment time point |
From recruitment to 6 months post hospital discharge, or death by any cause, up toFrom recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment
|
|
Health related quality of life
時間枠：from recruitment to 12 months post hospital discharge, or date of death from any cause (time points: 3,6 and 12 months post hospital discharge), up to 24 months from recruitment
|
Health-related quality of life assessed using the EQ-5D-5L. EQ-5D-5L health-state/index values and EQ visual analogue scale scores will be summarized as applicable at each assessment time point. |
from recruitment to 12 months post hospital discharge, or date of death from any cause (time points: 3,6 and 12 months post hospital discharge), up to 24 months from recruitment
|
|
Modified Barthel Index
時間枠：From recruitment to 12 months post hospital discharge, or death by any cause up to 24 months from recruitment
|
Functional independence measured using the Modified Barthel Index. Higher scores indicate greater independence in activities of daily living. Scores will be summarized at each assessment time point |
From recruitment to 12 months post hospital discharge, or death by any cause up to 24 months from recruitment
|
|
Return to work status
時間枠：From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment
|
Employment status prior to ICU admission and post hospital discharge will be assessed. Among participants employed before critical illness, the number and percentage who have returned to work will be reported. |
From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Feasibility of program
時間枠：From start of screening to 12 months post hospital discharge for the last patient recruited (approximately 24 months from start of study)
|
proportion of eligible patients successfully recruited out (screened at ICU discharge) |
From start of screening to 12 months post hospital discharge for the last patient recruited (approximately 24 months from start of study)
|
|
Five Times Sit to Stand
時間枠：From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment (time points :at hospital discharge, 3 and 6 months post hospital discharge
|
Time in seconds required to complete five sit-to-stand repetitions. Values will be summarized at each assessment time point and change over time described. |
From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment (time points :at hospital discharge, 3 and 6 months post hospital discharge
|
|
Grip strength
時間枠：From recruitment to 6 months post hospital discharge or date of death from any cause, up to 24 months from recruitment (Time points: ICU discharge, hospital discharge, 3 and 6 months post hospital discharge)
|
Handgrip strength with dynamometer |
From recruitment to 6 months post hospital discharge or date of death from any cause, up to 24 months from recruitment (Time points: ICU discharge, hospital discharge, 3 and 6 months post hospital discharge)
|
|
Modified Barthel Index
時間枠：From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment (Time points: hospital discharge, 3,6, 12 month post hospital discharge
|
Functional independence measured using the Modified Barthel Index. Higher scores indicate greater independence in activities of daily living. Scores will be summarized at each assessment time point and longitudinal change described. |
From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment (Time points: hospital discharge, 3,6, 12 month post hospital discharge
|
|
Mini-mental state examination
時間枠：From recruitment to 6 months post hospital discharge, up to 24 months from recruitment Time points: (Hospital discharge, 3, 6 month post hospital discharge)
|
Cognitive function measured using the MMSE. Scores will be summarized at each assessment time point and longitudinal change described. MoCA may be used where clinically indicated and will be reported separately rather than treated as equivalent to MMSE. |
From recruitment to 6 months post hospital discharge, up to 24 months from recruitment Time points: (Hospital discharge, 3, 6 month post hospital discharge)
|
|
Patient health questionnaire -9
時間枠：From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment (Time points :Hospital discharge, 3, 6 month post hospital discharge)
|
Depressive symptoms measured using the PHQ-9. Total scores will be summarized at each assessment time point and longitudinal change described. |
From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment (Time points :Hospital discharge, 3, 6 month post hospital discharge)
|
|
General anxiety scale-7
時間枠：From recruitment up to 24 months from recruitment (time points: hospital discharge, 3,6 month post hospital discharge)
|
Anxiety symptoms measured using the GAD-7. Total scores will be summarized at each assessment time point and longitudinal change described. |
From recruitment up to 24 months from recruitment (time points: hospital discharge, 3,6 month post hospital discharge)
|
|
Retention at 6 months
時間枠：From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment
|
Number of ICU survivors who have not withdrawn/ lost to follow up compared to original recruited number (excluding deaths) |
From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment
|
|
Completion of planned home visits
時間枠：6 months post hospital discharge, up to 24 months from recruitment
|
Monthly home visits x6 are planned per ICU survivor Number of planned home visits declined/ lost to follow up amongst survivors (excluding deaths) 3 and 6 month home visits converted to telehealth/ hospital visits |
6 months post hospital discharge, up to 24 months from recruitment
|
|
UCLA loneliness scale-3
時間枠：from recruitment up to 24 months post recruitment (time points 1,4 12 months post hospital discharge)
|
University of California Los Angeles loneliness scale-3 |
from recruitment up to 24 months post recruitment (time points 1,4 12 months post hospital discharge)
|
|
Caregiver burden
時間枠：From recruitment to 6 months post hospital discharge, or patient death by any cause , up to 24 hours post recruitment (Time points :1 and 6 months post hospital discharge)
|
Caregiver burden will be measured using the shortened 9-item Zarit Burden Interview (ZBI-9), with scores summarized over follow-up. |
From recruitment to 6 months post hospital discharge, or patient death by any cause , up to 24 hours post recruitment (Time points :1 and 6 months post hospital discharge)
|
|
reasons for non-participation or declining home visits
時間枠：at the point of enrolment into home visits at hospital discharge up to 6 months post hospital discharge, or death from any cause, whichever comes first , up to 24 months from recruitment
|
reasons for non-participation of home visits |
at the point of enrolment into home visits at hospital discharge up to 6 months post hospital discharge, or death from any cause, whichever comes first , up to 24 months from recruitment
|
|
Medication or follow-up appointment reconciliation events
時間枠：6 months post hospital discharge, from recruitment up to 24 months from recruitment
|
number of medication or follow up appointment reconciliation events done during home visits, per home visit |
6 months post hospital discharge, from recruitment up to 24 months from recruitment
|
|
Swallowing status
時間枠：From recruitment into study, up 24 months from recruitment, or death by any cause, whichever first (time points: at the Icu discharge, hospital discharge, 2 and 5 months post hospital discharge
|
In- hospital, oral intake and swallowing status assessed using the Functional Oral Intake Scale. EAT-10 questionnaire post hospital discharge; Scores will be summarized descriptively over follow-up. |
From recruitment into study, up 24 months from recruitment, or death by any cause, whichever first (time points: at the Icu discharge, hospital discharge, 2 and 5 months post hospital discharge
|
|
Body weight
時間枠：From recruitment into study, up to 24 months from recruitment, or death from any cause, whichever comes first (time points: pre ICU, at the Icu discharge, hospital discharge, 2 and 5 months post hospital discharge
|
Contributes to nutritional assessment Body weight measured in kilograms and summarized at each assessment time point and longitudinally. |
From recruitment into study, up to 24 months from recruitment, or death from any cause, whichever comes first (time points: pre ICU, at the Icu discharge, hospital discharge, 2 and 5 months post hospital discharge
|
|
arm and leg circumference
時間枠：From recruitment into study, up to 24months from recruitment or death from any cause, whichever comes first (Time points: at the Icu discharge, hospital discharge, 2 and 5 months post hospital discharge)
|
arm and leg circumference as a surrogate for nutritional status and muscle bulk. Excludes patients who have contraindications e.g. loss of limb, abnormal BMI, edema |
From recruitment into study, up to 24months from recruitment or death from any cause, whichever comes first (Time points: at the Icu discharge, hospital discharge, 2 and 5 months post hospital discharge)
|
|
Chelsea Critical Care Physical Assessment tool
時間枠：From recruitment into study, up to death from any cause or 24 months from recruitment, whichever comes first.
|
CPax |
From recruitment into study, up to death from any cause or 24 months from recruitment, whichever comes first.
|
|
Montreal Cognitive Assessment Tool
時間枠：From recruitment into study, 6 months post hospital discharge, or date of death from any cause, whichever comes first (if applicable)
|
MoCA assessment for patients screened with MMSE and have high suspicion of cognitive impairment |
From recruitment into study, 6 months post hospital discharge, or date of death from any cause, whichever comes first (if applicable)
|
|
healthcare utilisation
時間枠：12 months post hospital discharge
|
number of unplanned clinic visits, emergency department visits, unplanned admissions with reference from point of hospital discharge |
12 months post hospital discharge
|
|
mortality
時間枠：From recruitment to 12 months post hospital discharge, up till 24 months from recruitment, or death by any cause, whichever comes first
|
mortality |
From recruitment to 12 months post hospital discharge, up till 24 months from recruitment, or death by any cause, whichever comes first
|
|
return to work status
時間枠：From recruitment until 24 months from recruitment (time points: 3,6 12 months post hospital discharge)
|
for survivors who were working pre ICU admission, the number who returned to work |
From recruitment until 24 months from recruitment (time points: 3,6 12 months post hospital discharge)
|
その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
life-space
時間枠：From recruitment to 24 months from recruitment, or death from any cause, whichever comes first (Time points: Pre ICU admission, 3,6 and 12 months)
|
Life space at month 3, 6, 12 post hospital discharge |
From recruitment to 24 months from recruitment, or death from any cause, whichever comes first (Time points: Pre ICU admission, 3,6 and 12 months)
|
|
Clinical Frailty Scale
時間枠：From hospital admission up to 24 months from recruitment (Time points: pre-ICU baseline , hospital discharge, 3, 6, 12 months post hospital)
|
trajectory of CFS over time. Scores will be summarized descriptively across assessment time points. |
From hospital admission up to 24 months from recruitment (Time points: pre-ICU baseline , hospital discharge, 3, 6, 12 months post hospital)
|
|
User acceptability
時間枠：From recruitment up till 24 months from recruitment or date of death from any cause (Time points: 6 and 12 month post hospital discharge )
|
acceptability of the program and free text comments |
From recruitment up till 24 months from recruitment or date of death from any cause (Time points: 6 and 12 month post hospital discharge )
|
協力者と研究者
捜査官
捜査官
- 主任研究者：Yie Hui Lau、Tan Tock Seng Hospital
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- NTF_FY25_T1C1_17
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?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。