Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT04880967
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2021-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility of an App to Measure Patient Stressors in an Intensive Care Unit (ICU Feel Better App)- a Before-and-after Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2021-04-22', 'studyFirstSubmitQcDate': '2021-05-05', 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient reported perceived severity of patient stressors', 'timeFrame': 'Time until discharge from the intensive care unit, an expected average of 10 days', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Mental distress', 'timeFrame': 'Time until discharge from the intensive care unit, an expected average of 10 days', 'description': 'Mental distress is measured by Patient Health Questionnaire 4 \\[PHQ-4, range: 0-12, higher scores indicate higher distress\\]'}, {'measure': 'Acute perceived stress', 'timeFrame': 'Time until discharge from the intensive care unit, an expected average of 10 days', 'description': 'Acute perceived stress is measured by Stress Thermometer (range: 0-10, higher scores indicate higher stress)'}, {'measure': 'State anxiety', 'timeFrame': 'Time until discharge from the intensive care unit, an expected average of 10 days', 'description': 'State anxiety is measured with the Faces Anxiety Scale \\[FAS, range: 1-5, higher scores indicate higher anxiety\\]'}, {'measure': 'Pain', 'timeFrame': 'Time until discharge from the intensive care unit, an expected average of 10 days', 'description': 'Pain is measured with the Faces Pain Scale (range: 0-10, higher scores indicate higher pain)'}, {'measure': 'Self-reported cognitive functioning', 'timeFrame': 'Time until discharge from the intensive care unit, an expected average of 10 days', 'description': 'Self-reported cognitive functioning is measured with a list of problems of cognitive functions (range: 0-4, higher scores indicate worse cognitive functioning)'}, {'measure': 'Incidence of delirium', 'timeFrame': 'Time until discharge from the intensive care unit, an expected average of 10 days', 'description': 'Incidence of delirium is measured by CAM-ICU twice per day until'}, {'measure': 'Length of stay', 'timeFrame': 'Time until discharge from hospital, an expected average of 20 days', 'description': 'Length of stay is measured in days.'}, {'measure': 'Length of intensive care unit stay', 'timeFrame': 'Time until discharge from the intensive care unit, an expected average of 10 days', 'description': 'Length of intensive care unit stay is measured in days.'}, {'measure': 'Duration of mechanical ventilation', 'timeFrame': 'Time until discharge from the intensive care unit, an expected average of 10 days', 'description': 'Duration of mechanical ventilation is measured in hours.'}, {'measure': 'APACHE II-Score', 'timeFrame': 'Time until discharge from the intensive care unit, an expected average of 10 days', 'description': 'APACHE II score is measured by the Acute Physiology and Chronic Health Evaluation System II.'}, {'measure': 'Medication', 'timeFrame': 'Time until discharge from the intensive care unit, an expected average of 10 days', 'description': 'Medication is measured by data retrieved from the patient data management system.'}, {'measure': 'Treatment', 'timeFrame': 'Time until discharge from the intensive care unit, an expected average of 10 days', 'description': 'Treatment is measured by data retrieved from the patient data management system.'}, {'measure': 'Diagnoses', 'timeFrame': 'Time until discharge from the intensive care unit, an expected average of 10 days', 'description': 'Diagnoses are measured by ICD-10 codes retrieved from the patient data management system.'}, {'measure': 'Mode of intensive care unit admission', 'timeFrame': 'Time until discharge from the intensive care unit, an expected average of 10 days', 'description': 'Mode of intensive care unit admission is measured by admission data retrieved from the patient data management system.'}, {'measure': 'Diagnosis of post-intensive care syndrome (PICS)', 'timeFrame': 'Up to one month', 'description': 'Diagnosis of PICS is measured by an extensive clinical examination.'}, {'measure': 'Log data per patient', 'timeFrame': 'Time until discharge from the intensive care unit, an expected average of 10 days', 'description': 'Process data of app use: Log data per patient measured from start to end of app use'}, {'measure': 'Stressor intensity-', 'timeFrame': 'Time until discharge from the intensive care unit, an expected average of 10 days', 'description': 'Process data of app use: Stressor intensity measured from start to end of app use'}, {'measure': 'Support of study personal', 'timeFrame': 'Time until discharge from the intensive care unit, an expected average of 10 days', 'description': 'Number of app use trials with assistance of study personnel.'}, {'measure': 'Acceptance of app', 'timeFrame': 'Time until discharge from the intensive care unit, an expected average of 10 days', 'description': 'Patient reported acceptance of app use, daily until the end of app use'}, {'measure': 'Usability of app', 'timeFrame': 'Time until discharge from the intensive care unit, an expected average of 10 days', 'description': 'Patient reported usability of app, daily until the end of app use'}, {'measure': 'Relevance and understandability of app stressor items', 'timeFrame': 'Time until discharge from the intensive care unit, an expected average of 10 days', 'description': 'Patient reported relevance and understandability of app stressor items until the end of app use'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Delirium']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nIn 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.\n\nIn 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated in an ICU, aged 18 years and older', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients treated in an ICU\n* Duration of treatment ≥48h\n* Age: 18 years and older\n* Male, female, or divers gender\n\nExclusion Criteria:\n\n* Poor language skills\n* Statement in patient letter or living will that excludes participation\n* Participation in another prospective treatment study with indication delirium\n* Refusal of participation'}, 'identificationModule': {'nctId': 'NCT04880967', 'briefTitle': 'Feasibility of an App to Measure Patient Stressors in an Intensive Care Unit (ICU Feel Better App)- a Before-and-after Study', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Feasibility of an App to Measure Patient Stressors During Treatment in an Intensive Care Unit (ICU Feel Better App)- a Before-and-after Study', 'orgStudyIdInfo': {'id': 'ICU Feel Better App'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Standard Group', 'description': 'Cohort of n=20 intensive care unit patients from the ages of 18 years will be collected.\n\nParticipants of this cohort will not use the ICU Feel Better App.'}, {'label': 'Experimental Group', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - University Medicine Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Claudia Spies, MD, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Department of Anesthesiology and Operative intensive Care Medicine (CCM/CVK)', 'investigatorFullName': 'Claudia Spies', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}