Feasibility of an App to Measure Patient Stressors in an Intensive Care Unit (ICU Feel Better App)- a Before-and-after Study

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.

Study Overview

• Status: Completed
• Conditions: Delirium

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 Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

• Study Contact: Name: Claudia Spies, MD, Prof.; Phone Number: +49 30 450 55 11 02; Email: claudia.spies@charite.de

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - University Medicine Berlin
    • Contact: Claudia Spies, MD; Phone Number: +49 30 450 55 10 01; Email: claudia.spies@charite.de
    • Sub-Investigator: Henning Krampe, PhD
    • Sub-Investigator: Jakob Gülden, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated in an ICU, aged 18 years and older

Description

Inclusion Criteria:

• Patients treated in an ICU
• Duration of treatment ≥48h
• Age: 18 years and older
• Male, female, or divers gender

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Time until discharge from the intensive care unit, an expected average of 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental distress	Mental distress is measured by Patient Health Questionnaire 4 [PHQ-4, range: 0-12, higher scores indicate higher distress]	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)	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]	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)	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)	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	Time until discharge from the intensive care unit, an expected average of 10 days
Length of stay	Length of stay is measured in days.	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.	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.	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.	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.	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.	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.	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.	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.	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	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	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.	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	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	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	Time until discharge from the intensive care unit, an expected average of 10 days

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Study Director: Claudia Spies, MD, Prof., Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2023
• Primary Completion (Actual): October 11, 2023
• Study Completion (Actual): October 11, 2023

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: ICU Feel Better App

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No