Symptoms and SignsNCT05266118
Patient Reported Symptoms the First Week After Intensive Care Unit Discharge and up to Hospital Discharge
An observational study of Symptoms and Signs and Symptom Cluster, run by Ostfold Hospital Trust at 2 sites in Norway.
Trial summary
The overall objective of this study is a) to increase knowledge about ICU patient's symptoms and symptom clusters during the first week after ICU discharge, and b) to identify cognitive, psychological, and physical symptoms and health state at hospital discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptoms and Signs, Symptom Cluster, Follow-up Care
- Type of treatment
- Injection or infusion
- How many people
- 177 participants
- Where
- 2 sitesNorway
- Study dates
- 19 Apr 2022to 2 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: The target group of this study is former ICU patients. The patients will be recruited from a hospital in the South-Eastern part of Norway. In this hospital, ICU patients are treated in two different ICUs, one eight-bed mixed medical/surgical ICU (treating patients with both non-invasive and invasive mechanical ventilation) and one ten-bed medical ICU (treating patients with non-invasive ventilation only). The hospital wards may be both surgical and medical wards.
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Ostfold Hospital Trust
Sarpsborg, Gralum, 1714
Østfold Hospital Trust
Sarpsborg, Gralum, 1714
About this study
The overall objective of this study is a) to increase knowledge about ICU patient's symptoms and symptom clusters during the first week after ICU discharge, and b) to identify cognitive, psychological, and physical symptoms and health state at hospital discharge.
Read the 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).
- Conditions
- Symptoms and Signs, Symptom Cluster, Follow-up Care, Critical Illness
- Keywords
- Critical ill, PICS, Ward, Follow-up care, Symptoms and Signs
- Medical subject headings
- Signs and Symptoms, Syndrome, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple symptoms
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.
Measured: Up to 1 week after ICU discharge
Secondary outcomes (6)
Cognitive symptoms
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.
Measured: At hospital discharge, an average of one week
Posttraumatic stress symptoms
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.
Measured: At hospital discharge, an average of one week
Anxiety and depression
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.
Measured: At hospital discharge, an average of one week
Physical symptoms
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.
Measured: At hospital discharge, an average of one week
Health status
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.
Measured: At hospital discharge, an average of one week
Health-related quality of life state
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.
Measured: At hospital discharge, an average of one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start19 Apr 2022
- Primary completion21 Dec 2022
- Study completion2 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptoms and SignsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Nurses Organisation
- Responsible party
- Sponsor
- Investigators
- Brita Fosser Olsen, RN,PhD, Principal investigator, Østfold Hospital Trust Postbox 300, 1714 Grålum, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266118
- Sponsor's protocol ID
- 361816
- Status last verified
- Feb 2022
- First submitted
- 21 Jan 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Symptoms the First Week After Intensive Care Unit Discharge and up to Hospital Discharge
- ClinicalTrials.gov ID
- NCT05266118
- Acronym / sponsor ID
- 361816
- Conditions
- Symptoms and Signs, Symptom Cluster, Follow-up Care, Critical Illness
- Keywords
- Critical ill, PICS, Ward, Follow-up care, Symptoms and Signs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Collaborators
- Norwegian Nurses Organisation
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 4 Mar 2022 (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.
The overall objective of this study is a) to increase knowledge about ICU patient's symptoms and symptom clusters during the first week after ICU discharge, and b) to identify cognitive, psychological, and physical symptoms and health state at hospital discharge.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The target group of this study is former ICU patients. The patients will be recruited from a hospital in the South-Eastern part of Norway. In this hospital, ICU patients are treated in two different ICUs, one eight-bed mixed medical/surgical ICU (treating patients with both non-invasive and invasive mechanical ventilation) and one ten-bed medical ICU (treating patients with non-invasive ventilation only). The hospital wards may be both surgical and medical wards.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Multiple symptoms
Time frame: Up to 1 week after ICU discharge
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.
6 secondary outcomes
Cognitive symptoms
Time frame: At hospital discharge, an average of one week
Posttraumatic stress symptoms
Time frame: At hospital discharge, an average of one week
Anxiety and depression
Time frame: At hospital discharge, an average of one week
Physical symptoms
Time frame: At hospital discharge, an average of one week
Health status
Time frame: At hospital discharge, an average of one week
Health-related quality of life state
Time frame: At hospital discharge, an average of one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Brita Fosser Olsen, RN,PhD principal investigator
Østfold Hospital Trust Postbox 300, 1714 Grålum, Norway
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Symptoms and Signs and Symptom Cluster, run by Ostfold Hospital Trust at 2 sites in Norway.
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 0 inclusion and 4 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: finished, as of the sponsor's last update on 29 Mar 2023. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Multiple symptoms (time frame: Up to 1 week after ICU discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2023.