DeliriumNCT04880967
Feasibility of an App to Measure Patient Stressors in an Intensive Care Unit (ICU Feel Better App)- a Before-and-after Study
An observational study of Delirium, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This study examines the feasibility and efficacy of a mobile application (app), which enables critically ill patients to report perceived patient stressors to their caregivers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- 4 Jul 2023to 11 Oct 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated in an ICU, aged 18 years and older
Who may be able to join
- Patients treated in an ICU
- Duration of treatment ≥48h
- Age: 18 years and older
- Male, female, or divers gender
Who cannot join
- Poor language skills
- Statement in patient letter or living will that excludes participation
- Participation in another prospective treatment study with indication delirium
- Refusal of participation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - University Medicine Berlin
Berlin, 13353
About this study
Official title: Feasibility of an App to Measure Patient Stressors During Treatment in an Intensive Care Unit (ICU Feel Better App)- a Before-and-after Study
This study examines the feasibility and efficacy of a mobile application (app), which enables critically ill patients to report perceived patient stressors to their caregivers.
Read the detailed description
For many critically ill patients, treatment in an intensive care unit (ICU) is very stressful, and for some of the patients it is a traumatic experience. The domains of patient stressors encompass physical stressors, mental health stressors, communication stressors, and environmental stressors. The experience of stressors during ICU is associated with a higher risk of worse outcomes including delirium, delayed recovery, and post-intensive care syndrome (PICS). In the context of inpatient intensive care medicine, health care professionals (HCP) have problems to correctly rate the extent of their patients' stress.
In this study, we examine the feasibility and efficacy of a stressor-reporting system based on a mobile application (app), which allows critically ill patients to evaluate by themselves the intensity of their stressors, and thus, to communicate their stress experience to HCPs.
In the first assessment phase of this study, outcome data of a cohort of n=20 patients will be collected (cohort A). Participants of cohort A will not use the ICU Feel Better App. In the second phase, outcome data of another n=20 patients (cohort B) will be collected. Participants of cohort B will have the opportunity to use the ICU Feel Better App from the second day after admission to the ICU until the day of discharge from ICU.
- Conditions
- Delirium
- Medical subject headings
- Delirium
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 |
|---|---|---|
| Standard Group | Cohort of n=20 intensive care unit patients from the ages of 18 years will be collected. Participants of this cohort will not use the ICU Feel Better App. | |
| Experimental Group | Cohort of n=20 intensive care unit patients from the ages of 18 years will be collected. Participants of this cohort will have the opportunity to use the ICU Feel Better App every day from the second day after admission to the ICU until the day of discharge from ICU. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported perceived severity of patient stressors
Patient reported perceived severity of patient stressors (Mean score of patient stressor list ). Range: 0-4, higher scores indicate higher stress. At day 2 or 3 of ICU treatment (before first use of the app) (t1), and at the day before or the day of discharge from ICU (t2).
Measured: Time until discharge from the intensive care unit, an expected average of 10 days
Secondary outcomes (21)
Mental distress
Mental distress is measured by Patient Health Questionnaire 4 [PHQ-4, range: 0-12, higher scores indicate higher distress]
Measured: Time until discharge from the intensive care unit, an expected average of 10 days
Acute perceived stress
Acute perceived stress is measured by Stress Thermometer (range: 0-10, higher scores indicate higher stress)
Measured: Time until discharge from the intensive care unit, an expected average of 10 days
State anxiety
State anxiety is measured with the Faces Anxiety Scale [FAS, range: 1-5, higher scores indicate higher anxiety]
Measured: Time until discharge from the intensive care unit, an expected average of 10 days
Pain
Pain is measured with the Faces Pain Scale (range: 0-10, higher scores indicate higher pain)
Measured: Time until discharge from the intensive care unit, an expected average of 10 days
Self-reported cognitive functioning
Self-reported cognitive functioning is measured with a list of problems of cognitive functions (range: 0-4, higher scores indicate worse cognitive functioning)
Measured: Time until discharge from the intensive care unit, an expected average of 10 days
Incidence of delirium
Incidence of delirium is measured by CAM-ICU twice per day until
Measured: Time until discharge from the intensive care unit, an expected average of 10 days
Length of stay
Length of stay is measured in days.
Measured: Time until discharge from hospital, an expected average of 20 days
Length of intensive care unit stay
Length of intensive care unit stay is measured in days.
Measured: Time until discharge from the intensive care unit, an expected average of 10 days
Duration of mechanical ventilation
Duration of mechanical ventilation is measured in hours.
Measured: Time until discharge from the intensive care unit, an expected average of 10 days
APACHE II-Score
APACHE II score is measured by the Acute Physiology and Chronic Health Evaluation System II.
Measured: Time until discharge from the intensive care unit, an expected average of 10 days
Medication
Medication is measured by data retrieved from the patient data management system.
Measured: Time until discharge from the intensive care unit, an expected average of 10 days
Treatment
Treatment is measured by data retrieved from the patient data management system.
Measured: Time until discharge from the intensive care unit, an expected average of 10 days
Diagnoses
Diagnoses are measured by ICD-10 codes retrieved from the patient data management system.
Measured: Time until discharge from the intensive care unit, an expected average of 10 days
Mode of intensive care unit admission
Mode of intensive care unit admission is measured by admission data retrieved from the patient data management system.
Measured: Time until discharge from the intensive care unit, an expected average of 10 days
Diagnosis of post-intensive care syndrome (PICS)
Diagnosis of PICS is measured by an extensive clinical examination.
Measured: Up to one month
Log data per patient
Process data of app use: Log data per patient measured from start to end of app use
Measured: Time until discharge from the intensive care unit, an expected average of 10 days
Stressor intensity-
Process data of app use: Stressor intensity measured from start to end of app use
Measured: Time until discharge from the intensive care unit, an expected average of 10 days
Support of study personal
Number of app use trials with assistance of study personnel.
Measured: Time until discharge from the intensive care unit, an expected average of 10 days
Acceptance of app
Patient reported acceptance of app use, daily until the end of app use
Measured: Time until discharge from the intensive care unit, an expected average of 10 days
Usability of app
Patient reported usability of app, daily until the end of app use
Measured: Time until discharge from the intensive care unit, an expected average of 10 days
Relevance and understandability of app stressor items
Patient reported relevance and understandability of app stressor items until the end of app use
Measured: Time until discharge from the intensive care unit, an expected average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start4 Jul 2023
- Primary completion11 Oct 2023
- Study completion11 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880967
- Sponsor's protocol ID
- ICU Feel Better App
- Status last verified
- Jan 2024
- First submitted
- 22 Apr 2021
- Last updated
- 24 Jan 2024
- 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 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an App to Measure Patient Stressors During Treatment in an Intensive Care Unit (ICU Feel Better App)- a Before-and-after Study
- ClinicalTrials.gov ID
- NCT04880967
- Acronym / sponsor ID
- ICU Feel Better App
- Conditions
- Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 11 Oct 2023 (actual)
- Study completion
- 11 Oct 2023 (actual)
- First posted
- 11 May 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.
This study examines the feasibility and efficacy of a mobile application (app), which enables critically ill patients to report perceived patient stressors to their caregivers.
Detailed description
For many critically ill patients, treatment in an intensive care unit (ICU) is very stressful, and for some of the patients it is a traumatic experience. The domains of patient stressors encompass physical stressors, mental health stressors, communication stressors, and environmental stressors. The experience of stressors during ICU is associated with a higher risk of worse outcomes including delirium, delayed recovery, and post-intensive care syndrome (PICS). In the context of inpatient intensive care medicine, health care professionals (HCP) have problems to correctly rate the extent of their patients' stress.
In this study, we examine the feasibility and efficacy of a stressor-reporting system based on a mobile application (app), which allows critically ill patients to evaluate by themselves the intensity of their stressors, and thus, to communicate their stress experience to HCPs.
In the first assessment phase of this study, outcome data of a cohort of n=20 patients will be collected (cohort A). Participants of cohort A will not use the ICU Feel Better App. In the second phase, outcome data of another n=20 patients (cohort B) will be collected. Participants of cohort B will have the opportunity to use the ICU Feel Better App from the second day after admission to the ICU until the day of discharge from ICU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Group | – | –Cohort of n=20 intensive care unit patients from the ages of 18 years will be collected. Participants of this cohort will not use the ICU Feel Better App. |
| Experimental Group | – | –Cohort of n=20 intensive care unit patients from the ages of 18 years will be collected. Participants of this cohort will have the opportunity to use the ICU Feel Better App every day from the second day after admission to the ICU until the day of discharge from ICU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated in an ICU, aged 18 years and older
Key inclusion criteria (4 listed)
- Patients treated in an ICU
- Duration of treatment ≥48h
- Age: 18 years and older
- Male, female, or divers gender
Key exclusion criteria (4 listed)
- Poor language skills
- Statement in patient letter or living will that excludes participation
- Participation in another prospective treatment study with indication delirium
- Refusal of participation
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
Patient reported perceived severity of patient stressors
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Patient reported perceived severity of patient stressors (Mean score of patient stressor list ). Range: 0-4, higher scores indicate higher stress. At day 2 or 3 of ICU treatment (before first use of the app) (t1), and at the day before or the day of discharge from ICU (t2).
21 secondary outcomes
Mental distress
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Acute perceived stress
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
State anxiety
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Pain
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Self-reported cognitive functioning
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Incidence of delirium
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Length of stay
Time frame: Time until discharge from hospital, an expected average of 20 days
Length of intensive care unit stay
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Duration of mechanical ventilation
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
APACHE II-Score
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Medication
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Treatment
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Diagnoses
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Mode of intensive care unit admission
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Diagnosis of post-intensive care syndrome (PICS)
Time frame: Up to one month
Log data per patient
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Stressor intensity-
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Support of study personal
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Acceptance of app
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Usability of app
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Relevance and understandability of app stressor items
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
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 24 Jan 2024.
- 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.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Charite University, Berlin, Germany at 1 site in Germany.
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 4 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 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Patient reported perceived severity of patient stressors (time frame: Time until discharge from the intensive care unit, an expected average of 10 days). 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 24 Jan 2024.