Post ICU SyndromeMiCareNCT05066984
MONITOR-IC Post ICU Care Study
A study testing structured, multidisciplinary and personalized post-ICU care in people with Post ICU Syndrome, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post ICU Syndrome
- What is being tested?
- structured, multidisciplinary and personalized post-ICU care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,250 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Feb 2022to 1 Jul 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ICU patients at high risk of critical illness-associated morbidity post-ICU
- 18 years or older
- Patient or legal representative understands the Dutch language
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Radboudumc
Nijmegen, Gelderland, 6525GA
Canisius Wilhelmina Ziekenhuis
Nijmegen, Gelderland, 6532SZ
About this study
Official title: 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.
Read the 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.
- Conditions
- Post ICU Syndrome
- Being tested
- structured, multidisciplinary and personalized post-ICU care
- Keywords
- post-ICU care, cost-effectiveness, QoL, PROMs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| structured, multidisciplinary and personalized post-ICU care | Experimental | structured, multidisciplinary and personalized post-ICU care Receives: Other: structured, multidisciplinary and personalized post-ICU care |
| Ususal care | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year post-ICU
Secondary outcomes (7)
Physical functioning measured by fatigue assessed by the Checklist Individual Strength (CIS).
Fatigue (CIS) Patients' level of frailty and vulnerability will be assed using the Clinical Frailty Score (CFS).
Measured: 1- and 2-year post-ICU
Physical functioning measured by frailty assessed by the Clinical Frailty Scale (CFS).
Frailty (CFS) Patients' level of frailty and vulnerability will be assed using the Clinical Frailty Score (CFS).
Measured: 1- and 2-year post-ICU
Physical functioning measured by new physical complaints assessed by the number of new physical complaints.
New physical complaints Patients' level of frailty and vulnerability will be assed using the Clinical Frailty Score (CFS).
Measured: 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).
Post traumatic stress disorder (IES-R)
Measured: 1- and 2-year post-ICU
Cognitive functioning 1- and 2-year post-ICU assessed by the 14-item Cognitive Failure Questionnaire (CFQ14).
Cognitive functioning (CFQ14)
Measured: 1- and 2-year post-ICU
Social economic consequences measured by the novel question set designed by Griffiths et al.
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.)
Measured: 1- and 2-year post-ICU
Cost effectiveness measured by cost per Quality-Adjusted Life Years (QALY)
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.
Measured: 1- and 2-year post-ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start1 Feb 2022
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post ICU SyndromeStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter stepped-wedge cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 2,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Dutch National Health Care Institute
- Responsible party
- Sponsor
- Investigators
- Mark van den Boogaard, PhD, Study director, Radboud University Medical CenterMarieke Zegers, PhD, Study director, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066984
- Sponsor's protocol ID
- 2021-13125
- Acronym
- MiCare
- Status last verified
- Jul 2025
- First submitted
- 13 Sep 2021
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared on reasonable request to the researchers.
Publications
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.
PubMed 36109035
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Structured, Multidisciplinary and Personalized Post-ICU Care on Physical and Psychological Functioning, and Quality of Life of Former ICU Patients
- ClinicalTrials.gov ID
- NCT05066984
- Acronym / sponsor ID
- MiCare / 2021-13125
- Conditions
- Post ICU Syndrome
- Keywords
- post-ICU care, cost-effectiveness, QoL, PROMs
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,250 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Dutch National Health Care Institute
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter stepped-wedge cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| structured, multidisciplinary and personalized post-ICU care | Experimental | Other: structured, multidisciplinary and personalized post-ICU carestructured, multidisciplinary and personalized post-ICU care |
| Ususal care | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ICU patients at high risk of critical illness-associated morbidity post-ICU
- 18 years or older
- Patient or legal representative understands the Dutch language
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| structured, multidisciplinary and personalized post-ICU careStructured, personalized and multidisciplinary post-ICU care tailored to patients' health problems initiated by ICU clinicians and coordinated by GPs. | Other | structured, multidisciplinary and personalized post-ICU care |
Primary outcome
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.
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.
7 secondary outcomes
Physical functioning measured by fatigue assessed by the Checklist Individual Strength (CIS).
Time frame: 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
Physical functioning measured by new physical complaints assessed by the number of new physical complaints.
Time frame: 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
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
Social economic consequences measured by the novel question set designed by Griffiths et al.
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Derived from this study: PubMed 36109035van 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.
- Individual participant dataSharing planned: Yes. Data will be shared on reasonable request to the researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark van den Boogaard, PhD study director
Radboud University Medical Center
Marieke Zegers, PhD study director
Radboud University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing structured, multidisciplinary and personalized post-ICU care in people with Post ICU Syndrome, run by Radboud University Medical Center at 2 sites in Netherlands.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Individual's perception of their position in life assessed by the EuroQol-5 dimension (EQ5D) . (time frame: 1 year post-ICU). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05066984, which also lists 1 linked publication.
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 6 Aug 2025.