Clinical trial NCT04880967: Feasibility of an App to Measure Patient Stressors in an Intensive Care Unit (ICU Feel Better App)- a Before-and-after 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated in an ICU, aged 18 years and older

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.

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

Primary outcomes:
measure: Patient reported perceived severity of patient stressors
timeFrame: Time until discharge from the intensive care unit, an expected average of 10 days
Secondary outcomes:
measure: Mental distress
timeFrame: Time until discharge from the intensive care unit, an expected average of 10 days
measure: Acute perceived stress
timeFrame: Time until discharge from the intensive care unit, an expected average of 10 days
measure: State anxiety
timeFrame: Time until discharge from the intensive care unit, an expected average of 10 days
measure: Pain
timeFrame: Time until discharge from the intensive care unit, an expected average of 10 days
measure: Self-reported cognitive functioning
timeFrame: Time until discharge from the intensive care unit, an expected average of 10 days
measure: Incidence of delirium
timeFrame: Time until discharge from the intensive care unit, an expected average of 10 days
measure: Length of stay
timeFrame: Time until discharge from hospital, an expected average of 20 days
measure: Length of intensive care unit stay
timeFrame: Time until discharge from the intensive care unit, an expected average of 10 days
measure: Duration of mechanical ventilation
timeFrame: Time until discharge from the intensive care unit, an expected average of 10 days
measure: APACHE II-Score
timeFrame: Time until discharge from the intensive care unit, an expected average of 10 days
measure: Medication
timeFrame: Time until discharge from the intensive care unit, an expected average of 10 days
measure: Treatment
timeFrame: Time until discharge from the intensive care unit, an expected average of 10 days
measure: Diagnoses
timeFrame: Time until discharge from the intensive care unit, an expected average of 10 days
measure: Mode of intensive care unit admission
timeFrame: Time until discharge from the intensive care unit, an expected average of 10 days
measure: Diagnosis of post-intensive care syndrome (PICS)
timeFrame: Up to one month
measure: Log data per patient
timeFrame: Time until discharge from the intensive care unit, an expected average of 10 days
measure: Stressor intensity-
timeFrame: Time until discharge from the intensive care unit, an expected average of 10 days
measure: Support of study personal
timeFrame: Time until discharge from the intensive care unit, an expected average of 10 days
measure: Acceptance of app
timeFrame: Time until discharge from the intensive care unit, an expected average of 10 days
measure: Usability of app
timeFrame: Time until discharge from the intensive care unit, an expected average of 10 days
measure: Relevance and understandability of app stressor items
timeFrame: Time until discharge from the intensive care unit, an expected average of 10 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - University Medicine Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References: