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

Delirium Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04880967
• Other study ID #: ICU Feel Better App
• Status: Completed
• Start date: July 4, 2023
• Est. completion date: October 11, 2023

Study information

• Verified date: January 2024
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 11, 2023
• Est. primary completion date: October 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - University Medicine Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Length of stay	Length of stay is measured in days.	Time until discharge from hospital, an expected average of 20 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Diagnosis of post-intensive care syndrome (PICS)	Diagnosis of PICS is measured by an extensive clinical examination.	Up to one month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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