NCT05066984

Brief Summary

  • OBJECTIVE To evaluate the clinical effectiveness and cost effectiveness of structured, multidisciplinary and personalized post-ICU care versus usual care on physical and psychological functioning, and quality of life (QoL) of ICU survivors one and two years post-ICU.
  • RESEARCH QUESTION What is the clinical- and cost effectiveness of structured, personalized post-ICU care versus usual care on physical and psychological functioning, and QoL of ICU survivors?
  • HYPOTHESIS Structured, multidisciplinary, and personalized post-ICU care results in improved QoL of ICU survivors and is more cost effective compared to usual care.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,250

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Feb 2022Jul 2027

First Submitted

Initial submission to the registry

September 13, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

August 6, 2025

Status Verified

July 1, 2025

Enrollment Period

4.4 years

First QC Date

September 13, 2021

Last Update Submit

August 1, 2025

Conditions

Post ICU Syndrome

Keywords

post-ICU carecost-effectivenessQoLPROMs

Outcome Measures

Primary Outcomes (2)

  • Individual's perception of their position in life assessed by the EuroQol-5 dimension (EQ5D) .

    Quality of life (QoL) assessed by the EQ5D at 1-year post-ICU.

    1 year post-ICU

  • Mental impairments assessed by the Hospital Anxiety and Depression Scale (HADS)

    Anxiety and depression (assessed by the HADS) at 1-year post-ICU.

    1 year post-ICU

Secondary Outcomes (7)

  • Physical functioning measured by fatigue assessed by the Checklist Individual Strength (CIS).

    1- and 2-year post-ICU

  • Physical functioning measured by frailty assessed by the Clinical Frailty Scale (CFS).

    1- and 2-year post-ICU

  • Physical functioning measured by new physical complaints assessed by the number of new physical complaints.

    1- and 2-year post-ICU

  • Post traumatic stress disorder 1- and 2-year post-ICU assessed by the Impact of Event Scale-Revised (IES-R).

    1- and 2-year post-ICU

  • Cognitive functioning 1- and 2-year post-ICU assessed by the 14-item Cognitive Failure Questionnaire (CFQ14).

    1- and 2-year post-ICU

  • +2 more secondary outcomes

Study Arms (2)

structured, multidisciplinary and personalized post-ICU care

EXPERIMENTAL

structured, multidisciplinary and personalized post-ICU care

Other: structured, multidisciplinary and personalized post-ICU care

Ususal care

NO INTERVENTION

Usual care

Interventions

structured, multidisciplinary and personalized post-ICU careOTHER

Structured, personalized and multidisciplinary post-ICU care tailored to patients' health problems initiated by ICU clinicians and coordinated by GPs.

structured, multidisciplinary and personalized post-ICU care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ICU patients at high risk of critical illness-associated morbidity post-ICU
  • years or older
  • Patient or legal representative understands the Dutch language

You may not qualify if:

  • Patients discharged from ICU/hospital direct to a nursing home
  • Patients discharged from ICU/hospital direct to a medical or geriatric rehabilitation clinic
  • Patients discharged for palliative care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Radboudumc

Nijmegen, Gelderland, 6525GA, Netherlands

Location

Canisius Wilhelmina Ziekenhuis

Nijmegen, Gelderland, 6532SZ, Netherlands

Location

Related Publications (1)

  • van Sleeuwen D, van de Laar FA, Simons K, van Bommel D, Burgers-Bonthuis D, Koeter J, Bisschops LLA, Vloet L, Brackel M, Teerenstra S, Adang E, van der Hoeven JG, Zegers M, van den Boogaard M. MiCare study, an evaluation of structured, multidisciplinary and personalised post-ICU care on physical and psychological functioning, and quality of life of former ICU patients: a study protocol of a stepped-wedge cluster randomised controlled trial. BMJ Open. 2022 Sep 15;12(9):e059634. doi: 10.1136/bmjopen-2021-059634.

    PMID: 36109035DERIVED

Study Officials

  • Mark van den Boogaard, PhD

    Radboud University Medical Center

    STUDY DIRECTOR

  • Marieke Zegers, PhD

    Radboud University Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multicenter stepped-wedge cluster randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2021

First Posted

October 4, 2021

Study Start

February 1, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

August 6, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Data will be shared on reasonable request to the researchers.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
After finalizing the final analysis in 2026 for a period of 5 years.
Access Criteria
Data will be shared on reasonable request to the researchers.

Locations

NL(2)