Skip to main content
OpenTrials
Completed

NCT Number: NCT04880967

Feasibility of an App to Measure Patient Stressors 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Delirium Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Berlin, 13353, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. Mental distress

    Time frame: Time until discharge from the intensive care unit, an expected average of 10 days

    Mental distress is measured by Patient Health Questionnaire 4 [PHQ-4, range: 0-12, higher scores indicate higher distress]

  2. Acute perceived stress

    Time frame: Time until discharge from the intensive care unit, an expected average of 10 days

    Acute perceived stress is measured by Stress Thermometer (range: 0-10, higher scores indicate higher stress)

  3. State anxiety

    Time frame: Time until discharge from the intensive care unit, an expected average of 10 days

    State anxiety is measured with the Faces Anxiety Scale [FAS, range: 1-5, higher scores indicate higher anxiety]

  4. Pain

    Time frame: Time until discharge from the intensive care unit, an expected average of 10 days

    Pain is measured with the Faces Pain Scale (range: 0-10, higher scores indicate higher pain)

  5. Self-reported cognitive functioning

    Time frame: Time until discharge from the intensive care unit, an expected average of 10 days

    Self-reported cognitive functioning is measured with a list of problems of cognitive functions (range: 0-4, higher scores indicate worse cognitive functioning)

  6. Incidence of delirium

    Time frame: Time until discharge from the intensive care unit, an expected average of 10 days

    Incidence of delirium is measured by CAM-ICU twice per day until

  7. Length of stay

    Time frame: Time until discharge from hospital, an expected average of 20 days

    Length of stay is measured in days.

  8. Length of intensive care unit stay

    Time frame: Time until discharge from the intensive care unit, an expected average of 10 days

    Length of intensive care unit stay is measured in days.

  9. Duration of mechanical ventilation

    Time frame: Time until discharge from the intensive care unit, an expected average of 10 days

    Duration of mechanical ventilation is measured in hours.

  10. APACHE II-Score

    Time frame: Time until discharge from the intensive care unit, an expected average of 10 days

    APACHE II score is measured by the Acute Physiology and Chronic Health Evaluation System II.

  11. Medication

    Time frame: Time until discharge from the intensive care unit, an expected average of 10 days

    Medication is measured by data retrieved from the patient data management system.

  12. Treatment

    Time frame: Time until discharge from the intensive care unit, an expected average of 10 days

    Treatment is measured by data retrieved from the patient data management system.

  13. Diagnoses

    Time frame: Time until discharge from the intensive care unit, an expected average of 10 days

    Diagnoses are measured by ICD-10 codes retrieved from the patient data management system.

  14. Mode of intensive care unit admission

    Time frame: Time until discharge from the intensive care unit, an expected average of 10 days

    Mode of intensive care unit admission is measured by admission data retrieved from the patient data management system.

  15. Diagnosis of post-intensive care syndrome (PICS)

    Time frame: Up to one month

    Diagnosis of PICS is measured by an extensive clinical examination.

  16. Log data per patient

    Time frame: Time until discharge from the intensive care unit, an expected average of 10 days

    Process data of app use: Log data per patient measured from start to end of app use

  17. Stressor intensity-

    Time frame: Time until discharge from the intensive care unit, an expected average of 10 days

    Process data of app use: Stressor intensity measured from start to end of app use

  18. Support of study personal

    Time frame: Time until discharge from the intensive care unit, an expected average of 10 days

    Number of app use trials with assistance of study personnel.

  19. Acceptance of app

    Time frame: Time until discharge from the intensive care unit, an expected average of 10 days

    Patient reported acceptance of app use, daily until the end of app use

  20. Usability of app

    Time frame: Time until discharge from the intensive care unit, an expected average of 10 days

    Patient reported usability of app, daily until the end of app use

  21. Relevance and understandability of app stressor items

    Time frame: Time until discharge from the intensive care unit, an expected average of 10 days

    Patient reported relevance and understandability of app stressor items until the end of app use

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 11, 2021
Registry last updated
Jan 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.