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

NCT07854080 | Not Yet Recruiting DMC

• 1 other identifier: NTF_FY25_T1C1_17
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Post ICU Syndrome

Keywords

post icu syndrome; critical care; implementation study; rehabilitation

Outcome Measures

Primary Outcomes (8)

• 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.

  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

  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

  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

  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

  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

  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

  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

  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

Secondary Outcomes (21)

• Feasibility of program

  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

  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

  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

  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

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

Other Outcomes (3)

• life-space

  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

  From hospital admission up to 24 months from recruitment (Time points: pre-ICU baseline , hospital discharge, 3, 6, 12 months post hospital)

• User acceptability

  From recruitment up till 24 months from recruitment or date of death from any cause (Time points: 6 and 12 month post hospital discharge )

Study Arms (1)

Single arm feasibility study

EXPERIMENTAL

Other: THRIVE@TTSH follow up program

Interventions

THRIVE@TTSH follow up program OTHER

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

Single arm feasibility study

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Mental-health screening will not be interpreted as diagnostic criteria for anxiety or depressive disorders.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead

Study Officials

• Yie Hui Lau

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yie Hui Lau

CONTACT

+65 63577771; yie.hui.lau@nhghealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Model Details: 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

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 31, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share