Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-27 @ 11:50 PM
Study NCT ID:
NCT05258734
Status:
COMPLETED
Last Update Posted:
2022-11-17
First Post:
2022-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Mobile Health Application Based on Omaha System on Symptoms and Quality of Life in COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-10-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-15', 'studyFirstSubmitDate': '2022-02-05', 'studyFirstSubmitQcDate': '2022-02-25', 'lastUpdatePostDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Physical Symptom Status', 'timeFrame': 'Baseline, 1st month, 2nd month and 3rd month.', 'description': 'Physical symptom status will be assessed using the Omaha System Problem Rating Scale for Outcomes. The Problem Rating Scale for Outcomes is a method to evaluate patient progress throughout the period of service. It consists of three five-point, Likert-type scales to measure the entire range of severity for the concepts of Knowledge, Behavior, and Status.'}, {'measure': 'Change in Psychosocial Symptom Status', 'timeFrame': 'Baseline, 1st month, 2nd month and 3rd month.', 'description': 'Psychosocial symptom status will be evaluated with Depression Anxiety Stress Scale- 21 (DASS-21). DASS-21 is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. For depression the cutoff scores are: Normal: 0-9, Mild: 10-12, Moderate:13-20, Severe: 21-27, and Extremely severe: 28-42.\n\nFor anxiety the cutoff scores are: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe:15-19, and Extremely severe: 20-42. For stress the cutoff scores are: Normal: 0-10, Mild:11-18, Moderate:19-26, Severe: 27-34, and Extremely severe: 35-42.'}, {'measure': 'Change in Cognitive Symptom Status', 'timeFrame': 'Baseline, 1st month, 2nd month and 3rd month.', 'description': 'Cognitive symptom status will be assessed using the Omaha System Problem Rating Scale for Outcomes. The Problem Rating Scale for Outcomes is a method to evaluate patient progress throughout the period of service. It consists of three five-point, Likert-type scales to measure the entire range of severity for the concepts of Knowledge, Behavior, and Status.'}, {'measure': 'Change in Quality of Life', 'timeFrame': 'Baseline, 1st month, 2nd month and 3rd month.', 'description': "Quality of life will be evaluated with the SF-12. The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.\n\nThe SF-12 is a shortened version of it's predecessor, the SF-36, which itself evolved from the Medical Outcomes Study. The SF-12 was created to reduce the burden of response.\n\nThe SF-12 uses the same eight domains as the SF-36:\n\nLimitations in physical activities because of health problems. Limitations in social activities because of physical or emotional problems Limitations in usual role activities because of physical health problems Bodily pain General mental health (psychological distress and well-being) Limitations in usual role activities because of emotional problems Vitality (energy and fatigue) General health perceptions"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Omaha System', 'Mobile health app'], 'conditions': ['COVID-19', 'Symptoms and Signs', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'Purpose: The aim of this study is to evaluate the effects of nursing interventions made with a mobile health application (COVOS) developed based on the Omaha System on the physical, psychosocial and cognitive symptoms and quality of life of patients diagnosed with COVID-19, and continuing treatment at home.\n\nDesign: This is a single center, 1:1 randomized, single blind, parallel, active comparator trial.\n\nMethod: Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Statement 2013 checklist used in study. The CONSORT (Consolidated Standards of Reporting Trials) flowchart is used in this protocol. This study will carried out in a family health center, located within the boundaries of İzmit District of Kocaeli province. The patients in the experimental group will be followed up with the COVOS app and nursing interventions (videos, information messages) to manage their symptoms will be directed with the COVOS app. The patients in the control group will not receive any intervention, the standard follow-up and health care provided by the family health center of the patients will continue.\n\nHypothesis: In patients diagnosed with COVID-19 followed at home with COVOS, symptom management and quality of life will be better in 1st, 2nd and 3rd months compared to the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a positive Polymerase Chain Reaction (PCR) test within the last 24-48 hours\n* Patients whose symptoms started within the last 48 hours\n* Patients experiencing at least one symptom\n* Patients diagnosed with COVID-19 and continuing treatment at home\n* Literate patients\n* Patients with smartphone\n\nExclusion Criteria:\n\n* Those who have had a previous COVID-19 infection\n* Patients with vision or hearing problems\n* Patients with chronic disease\n* Patients with mental illness\n* Patients who do not have a smartphone\n* Pregnant and postpartum patients\n* Patients who did not agree to participate in the study'}, 'identificationModule': {'nctId': 'NCT05258734', 'briefTitle': 'The Effect of Mobile Health Application Based on Omaha System on Symptoms and Quality of Life in COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'The Effect Of Mobile Health Application Based On Omaha System On Physical, Psychosocial, Cognitive Symptoms And Quality Of Life In COVID-19 Patients', 'orgStudyIdInfo': {'id': '4802180417'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COVOS app', 'interventionNames': ['Other: COVOS app']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'interventionNames': ['Other: Standard Care']}], 'interventions': [{'name': 'COVOS app', 'type': 'OTHER', 'description': 'In this study, the patients in the experimental group will be followed up with the COVOS app and nursing interventions (videos, information messages) to manage their symptoms will be directed with the COVOS app.', 'armGroupLabels': ['COVOS app']}, {'name': 'Standard Care', 'type': 'OTHER', 'description': 'In this study, the patients in the control group will not receive any intervention, the standard follow-up and health care provided by the family health center of the patients will continue.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kocaeli', 'state': 'İzmit', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}], 'overallOfficials': [{'name': 'Selda Seçginli, Prof.Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'İstanbul University Cerrahpasa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, {'name': 'The Scientific and Technological Research Council of Turkey', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Gizemnur Torun', 'investigatorAffiliation': 'Kocaeli University'}}}}