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Post ICU SyndromeTHRIVE@TTSHNCT07854080

Protocol for a Hybrid Implementation-effectiveness Feasibility Study of a Transdisciplinary ICU-to-home Recovery Model

A study testing THRIVE@TTSH follow up program in people with Post ICU Syndrome, run by Tan Tock Seng Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Post ICU Syndrome
What is being tested?
THRIVE@TTSH follow up program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
31 Oct 2026to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Official title: 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.

Read the detailed description

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.

Being tested
THRIVE@TTSH follow up program
Keywords
post icu syndrome, critical care, implementation study, rehabilitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • THRIVE@TTSH follow up programOther

    1. Structured post-ICU screening
    2. Comprehensive multidomain assessment
    3. Personalised ICU recovery summary
    4. Multidisciplinary review and closed-loop care coordination
    5. Volunteer-supported home follow-up and multidisciplinary meetings
Study groups in NCT07854080
Study groupRoleWhat they receive
Single arm feasibility studyExperimentalNot described
Receives: Other: THRIVE@TTSH follow up program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. completion of the Month-6 PICS physical assessment

    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.

    Measured: From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment

  2. completion of the Month 6 physical domain assessment

    Handgrip strength measured in kilograms using a standardized dynamometer procedure. Values will be summarized at each assessment time point and longitudinal change described.

    Measured: From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment

  3. completion of Month 6 Cognitive domain assessment

    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.

    Measured: 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)

  4. Completion of Month 6 Mental Domain assessment

    Depressive symptoms screened using the Patient Health Questionnaire-9(PHQ-9). Total scores will be summarized at each assessment time point

    Measured: From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment

  5. Completion of Month 6 Mental Domain Assessment

    Anxiety symptoms screened using the GAD-7. Total scores will be summarized at each assessment time point

    Measured: 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

  6. Health related quality of life

    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.

    Measured: 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

  7. Modified Barthel Index

    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

    Measured: From recruitment to 12 months post hospital discharge, or death by any cause up to 24 months from recruitment

  8. Return to work status

    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.

    Measured: From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment

Secondary outcomes (21)
  1. Feasibility of program

    proportion of eligible patients successfully recruited out (screened at ICU discharge)

    Measured: From start of screening to 12 months post hospital discharge for the last patient recruited (approximately 24 months from start of study)

  2. Five 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.

    Measured: 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

  3. Grip strength

    Handgrip strength with dynamometer

    Measured: 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)

  4. Modified Barthel Index

    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.

    Measured: 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

  5. Mini-mental state examination

    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.

    Measured: From recruitment to 6 months post hospital discharge, up to 24 months from recruitment Time points: (Hospital discharge, 3, 6 month post hospital discharge)

  6. Patient health questionnaire -9

    Depressive symptoms measured using the PHQ-9. Total scores will be summarized at each assessment time point and longitudinal change described.

    Measured: 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)

  7. General anxiety scale-7

    Anxiety symptoms measured using the GAD-7. Total scores will be summarized at each assessment time point and longitudinal change described.

    Measured: From recruitment up to 24 months from recruitment (time points: hospital discharge, 3,6 month post hospital discharge)

  8. Retention at 6 months

    Number of ICU survivors who have not withdrawn/ lost to follow up compared to original recruited number (excluding deaths)

    Measured: From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment

  9. Completion of planned home visits

    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

    Measured: 6 months post hospital discharge, up to 24 months from recruitment

  10. UCLA loneliness scale-3

    University of California Los Angeles loneliness scale-3

    Measured: from recruitment up to 24 months post recruitment (time points 1,4 12 months post hospital discharge)

  11. Caregiver burden

    Caregiver burden will be measured using the shortened 9-item Zarit Burden Interview (ZBI-9), with scores summarized over follow-up.

    Measured: 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)

  12. reasons for non-participation or declining home visits

    reasons for non-participation of home visits

    Measured: 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

  13. Medication or follow-up appointment reconciliation events

    number of medication or follow up appointment reconciliation events done during home visits, per home visit

    Measured: 6 months post hospital discharge, from recruitment up to 24 months from recruitment

  14. Swallowing status

    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.

    Measured: 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

  15. Body weight

    Contributes to nutritional assessment Body weight measured in kilograms and summarized at each assessment time point and longitudinally.

    Measured: 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

  16. arm and leg circumference

    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

    Measured: 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)

  17. Chelsea Critical Care Physical Assessment tool

    CPax

    Measured: From recruitment into study, up to death from any cause or 24 months from recruitment, whichever comes first.

  18. Montreal Cognitive Assessment Tool

    MoCA assessment for patients screened with MMSE and have high suspicion of cognitive impairment

    Measured: From recruitment into study, 6 months post hospital discharge, or date of death from any cause, whichever comes first (if applicable)

  19. healthcare utilisation

    number of unplanned clinic visits, emergency department visits, unplanned admissions with reference from point of hospital discharge

    Measured: 12 months post hospital discharge

  20. mortality

    mortality

    Measured: From recruitment to 12 months post hospital discharge, up till 24 months from recruitment, or death by any cause, whichever comes first

  21. return to work status

    for survivors who were working pre ICU admission, the number who returned to work

    Measured: From recruitment until 24 months from recruitment (time points: 3,6 12 months post hospital discharge)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2026
  2. Study start31 Oct 2026 (estimated)
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
This is a prospective, single-centre study using a Type 3 hybrid implementation-effectiveness feasibility design, as described by Curran et al. The study is designed to evaluate whether THRIVE@TTSH can be delivered within routine clinical and community workflows. Implementation outcomes will be informed by Proctor's framework, including feasibility, acceptability and fidelity. RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) will provide the broader reporting framework; effectiveness outcomes will be exploratory
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07854080
Sponsor's protocol ID
NTF_FY25_T1C1_17
Acronym
THRIVE@TTSH
Status last verified
Sep 2026
First submitted
21 Sep 2026
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing THRIVE@TTSH follow up program in people with Post ICU Syndrome, run by Tan Tock Seng Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yie Hui Lau (+65 63577771, yie.hui.lau@nhghealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

completion of the Month-6 PICS physical assessment (time frame: From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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