MONITOR-IC Post ICU Care Study (MiCare)

August 1, 2025 updated by: Radboud University Medical Center

Evaluation of Structured, Multidisciplinary and Personalized Post-ICU Care on Physical and Psychological Functioning, and Quality of Life of Former ICU Patients

  • 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

  • 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.
  • STUDY POPULATION Adult patients at high risk of critical illness-associated morbidity post-ICU.
  • INTERVENTION Structured, personalized and multidisciplinary post-ICU care tailored to patients' health problems initiated by ICU clinicians and coordinated by GPs.
  • USUAL CARE / COMPARISON No or unstructured post-ICU care.
  • OUTCOMES Primary: QoL and mental functioning 1-year post-ICU. Secondary: physical and cognitive functioning 1- and 2-year post-ICU, cost effectiveness and cost utility.
  • FOLLOW-UP TIME One and two years post-ICU.
  • STUDY DESIGN Stepped wedge cluster RCT in 5 hospitals.
  • SAMPLE SIZE & DATA ANALYSIS 5 ICUs (11 patients/ICU/month, in total 770 intervention patients, and 1480 (active and historical) controls gives power of 87% to detect effect of 0.074 in EQ-5D (ICC 0.035; SD 0.26). Data will be analysed according to intention to treat principles, also per-protocol analyses will be performed.
  • COST-EFFECTIVENESS ANALYSIS / BUDGET IMPACT ANALYSIS Comparison of 'cost per QALY' gained between patients in the intervention and control group. Decision analytical modelling will be used to calculate the average savings per patient; extrapolated to population level using a budget-holders perspective.

Study Type

Interventional

Enrollment (Estimated)

2250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525GA
        • Radboudumc
      • Nijmegen, Gelderland, Netherlands, 6532SZ
        • Canisius Wilhelmina Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: structured, multidisciplinary and personalized post-ICU care
Other: structured, multidisciplinary and personalized post-ICU care
Structured, personalized and multidisciplinary post-ICU care tailored to patients' health problems initiated by ICU clinicians and coordinated by GPs.
No Intervention: Ususal care
Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual's perception of their position in life assessed by the EuroQol-5 dimension (EQ5D) .
Time Frame: 1 year post-ICU
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)
Time Frame: 1 year post-ICU
Anxiety and depression (assessed by the HADS) at 1-year post-ICU.
1 year post-ICU

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical functioning measured by fatigue assessed by the Checklist Individual Strength (CIS).
Time Frame: 1- and 2-year post-ICU
Fatigue (CIS) Patients' level of frailty and vulnerability will be assed using the Clinical Frailty Score (CFS).
1- and 2-year post-ICU
Physical functioning measured by frailty assessed by the Clinical Frailty Scale (CFS).
Time Frame: 1- and 2-year post-ICU
Frailty (CFS) Patients' level of frailty and vulnerability will be assed using the Clinical Frailty Score (CFS).
1- and 2-year post-ICU
Physical functioning measured by new physical complaints assessed by the number of new physical complaints.
Time Frame: 1- and 2-year post-ICU
New physical complaints Patients' level of frailty and vulnerability will be assed using the Clinical Frailty Score (CFS).
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).
Time Frame: 1- and 2-year post-ICU
Post traumatic stress disorder (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).
Time Frame: 1- and 2-year post-ICU
Cognitive functioning (CFQ14)
1- and 2-year post-ICU
Social economic consequences measured by the novel question set designed by Griffiths et al.
Time Frame: 1- and 2-year post-ICU

Social consequences and return to work will be measured using the novel question set designed by Griffiths et al to determine changes in family circumstances, socioeconomic stability and care requirements.

(Griffiths J, Hatch RA, Bishop J, et al. An exploration of social and economic outcome and associated health-related quality of life after critical illness in general intensive care unit survivors: a 12-month follow-up study. Critical care. 2013;17(3):R100.)
1- and 2-year post-ICU
Cost effectiveness measured by cost per Quality-Adjusted Life Years (QALY)
Time Frame: 1- and 2-year post-ICU
A cost-effectiveness analysis will be carried out to evaluate whether the costs of structured, multidisciplinary and personalized post-ICU care weigh up to the benefits compared to usual care.
1- and 2-year post-ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development
Dutch National Health Care Institute

Investigators

  • Study Director: Mark van den Boogaard, PhD, Radboud University Medical Center
  • Study Director: Marieke Zegers, PhD, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

September 13, 2021

First Submitted That Met QC Criteria

September 22, 2021

First Posted (Actual)

October 4, 2021

Study Record Updates

Last Update Posted (Actual)

August 6, 2025

Last Update Submitted That Met QC Criteria

August 1, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021-13125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared on reasonable request to the researchers.

IPD Sharing Time Frame

After finalizing the final analysis in 2026 for a period of 5 years.

IPD Sharing Access Criteria

Data will be shared on reasonable request to the researchers.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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