- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05266118
Patient Reported Symptoms the First Week After Intensive Care Unit Discharge and up to Hospital Discharge
Study Overview
Status
Detailed Description
Several studies have examined how ICU patients experience being in the ICU, and up to 75% of ICU patients experience multiple intensive care related symptoms while in the ICU. Other studies have examined ICU patients' transfer from ICU to hospital wards, and the transfer may cause mixed emotions for the patient, both positive perception of an improvement in the patient's condition, but also negative perception of decreased monitoring of the patient and less staff involvement in their care. Further, extensive literature exists examining the long-term effects of being an ICU patient, and a major proportion of ICU survivors develop a combination of cognitive, psychological, and physical symptoms, which can persist for months or even years after hospital discharge. This phenomena is now recognized as post intensive care syndrome (PICS). These consequences are associated with a combination of reduced quality of life, impaired functional status and impaired daily functioning, and has consequences for both ICU survivors and their families. However, studies about what ICU patients' experience just after ICU discharge (in hospital wards), is scarce. In this time, patients are still in need of advanced personalized care after having survived critical illness and intensive care treatment.
This study will increase knowledge about symptoms and symptom clusters in ICU patients during the first week after ICU discharge, and at hospital discharge. In these areas, evidence is lacking. This knowledge will help health care providers to optimize and improve patient care and recovery during the first time period after critically illness, by providing more tailored symptom management at the right time in future support strategies and future plans for rehabilitation.
The present study is a single-center study and has a prospective, longitudinal design. A set of different symptoms are measured in 170 former ICU patients the first week after ICU discharge, in addition to a set of cognitive, psychological, and physical symptoms and health state at hospital discharge. We will measure:
- Totally 32 different symptoms on day 1; day 3; day 5; and day 7 after ICU discharge
- A set of cognitive (assessing the level of cognitive function), psychological (posttraumatic stress, anxiety, depression), and physical symptoms (activities of daily life) and health status at hospital discharge. The same set of questionnaires will be filled in during ward stay reflecting patient situation one week prior to ICU admittance (used as baseline measures).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Mette Nikolaisen, RN,MSc
- Phone Number: 004745448167
- Email: mette.kure.nikolaisen@so-hf.no
Study Locations
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Gralum
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Sarpsborg, Gralum, Norway, 1714
- Ostfold Hospital Trust
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Sarpsborg, Gralum, Norway, 1714
- Østfold Hospital Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria: Participants is former ICU patients over 18 years, immediately after transferred from ICU to a hospital ward
At least one of these criteria is needed for the participation in the study:
- ICU stays > 24 hours
- Ventilatory support
- Transferals to other ICU < 24 hours
- Continuous infusion of vasoactive substances
Exclusion criteria:
- Not able to understand, read or write Norwegian
- Not able to communicate verbally
- A manifest cognitive deficit (e.g., dementia or delirium)
- Re-admission to ICU < 72 timer
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Former ICU patients
Participants is former ICU patients, immediately after transferred from ICU to a hospital ward.
At least one of these criteria is needed for the participation in the study: ICU stays > 24 hours; ventilatory support; transferals to other ICU < 24 hours; continuous infusion of vasoactive substances.
In addition, to be included, the patients must be more than 18 years of age; understand and be able to write and read Norwegian; be able to communicate verbally; not have a manifest cognitive deficit; and not being readmitted to ICU < 72 hours
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Multiple symptoms
Time Frame: Up to 1 week after ICU discharge
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Multiple symptoms is measured with the Memorial Symptoms Assessment Scale (MSAS).The patients will be asked to indicate whether they experience 32 different symptoms (i.e., occurence).
Those who experience a symptom will be asked to rate its frequency (from rarely [1 point] to almost constantly [4 points]); intensity (from slight [1 p] to very severe [4 p]); and distress or bother (from not at all [0 p] to very much [4 p]).
Here, higher score indicate worse symptom experience.
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Up to 1 week after ICU discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive symptoms
Time Frame: At hospital discharge, an average of one week
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Level of cognitive functioning is measured with The Mini Montreal Cognitive Assessment (Mini MoCA).
Mini MoCA assess memory/attention; language; orientation; and delayed recall.
The score can range from 0 to 15 points.
Higher scores indicate better cognitive function, and 12 points or more is considered as normal.
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At hospital discharge, an average of one week
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Posttraumatic stress symptoms
Time Frame: At hospital discharge, an average of one week
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Posttraumatic stress symptoms is measured with Impact of event scale-revised (IES-R), a 22-item scale measuring the presence and severity of posttraumatic stress symptoms.
Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely).
The total IES-R score range is 0-88; and higher score indicate higher symptom level.
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At hospital discharge, an average of one week
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Anxiety and depression
Time Frame: At hospital discharge, an average of one week
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Anxiety and depression is measured with Hospital Anxiety and Depression Scale (HADS).
HADS consists of 14 items, with seven each for measuring anxiety and depression.
Each item can be scored on a scale from 0 (not at all) to 3 (very much).
An overall score from 0 to 21 can be calculated for each subscale with the following score breakdown: 0 - 7: Normal levels of anxiety/depression; 8-10: Borderline abnormal; and > 11: Abnormal.
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At hospital discharge, an average of one week
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Physical symptoms
Time Frame: At hospital discharge, an average of one week
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Activities of Daily Living is measured with Katz Index of Independence in Activities of Daily Living.
Katz measures the patient's ability to perform personal activities of daily living; bathing, dressing, toileting, transferring, continence, and feeding.
Each item are scored as independence (1 point) or dependence (0 point).
The total score can range from 0 to 6 points; a score of 2 indicates severe functional impairment; a score of 4 indicates moderate function, and a score of 6 points indicates full physical function.
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At hospital discharge, an average of one week
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Health status
Time Frame: At hospital discharge, an average of one week
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Health status is measured with EQ-5D-5L.
This tool assess walking, personal care, common chores, pain/ discomfort, and anxiety/ depression.
Each item is rated on a 5 point Likert scale from 0 (no problem) to 5 (unable to or very strong symptoms).
The total score can range from 0 to 25 points, and higher score indicates better health status.
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At hospital discharge, an average of one week
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Health-related quality of life state
Time Frame: At hospital discharge, an average of one week
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Health-related quality of life state is measured with the visual analog scale of the EQ-5D-5L.
The scale range from 0-100, with higher scores indicating better health status.
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At hospital discharge, an average of one week
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 361816
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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