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

NCT04880967 | Completed

• 1 other identifier: ICU Feel Better App
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Mental distress

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

• Acute perceived stress

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

• State anxiety

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

• Pain

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

• Self-reported cognitive functioning

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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated in an ICU, aged 18 years and older

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• Claudia Spies, MD, Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Anesthesiology and Operative intensive Care Medicine (CCM/CVK)

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: May 11, 2021
• Study Start: July 4, 2023
• Primary Completion: October 11, 2023
• Study Completion: October 11, 2023
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)