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

NCT ID: NCT04880967

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-04
• Study Completion Date: 2023-10-11

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Claudia Spies

Head of the Department of Anesthesiology and Operative intensive Care Medicine (CCM/CVK)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia Spies, MD, Prof.

Role: STUDY_DIRECTOR

Charite University, Berlin, Germany

Locations

Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - University Medicine Berlin

Berlin, , Germany

Countries

Germany

Other Identifiers

ICU Feel Better App

Identifier Type: -

Identifier Source: org_study_id