Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-26 @ 1:22 PM
Study NCT ID:
NCT05715593
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2023-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of a Health Education Intervention to Reduce Anxiety in Quarantined COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006266', 'term': 'Health Education'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'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': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 402}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-03', 'studyFirstSubmitDate': '2023-02-03', 'studyFirstSubmitQcDate': '2023-02-03', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of anxiety reduction', 'timeFrame': 'One week (7 days) after the COVID 19 diagnosis', 'description': 'The rate of anxiety reduction in each group at Day 7 based on a HAD-A score ≥ 8'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health Education, COVID-19, Quarantine, Anxiety, Pandemic']}, 'referencesModule': {'references': [{'pmid': '37340300', 'type': 'DERIVED', 'citation': 'Zemni I, Gara A, Nasraoui H, Kacem M, Maatouk A, Trimeche O, Abroug H, Fredj MB, Bennasrallah C, Dhouib W, Bouanene I, Belguith AS. The effectiveness of a health education intervention to reduce anxiety in quarantined COVID-19 patients: a randomized controlled trial. BMC Public Health. 2023 Jun 20;23(1):1188. doi: 10.1186/s12889-023-16104-w.'}]}, 'descriptionModule': {'briefSummary': 'we aimed to assess the impact of health education on the anxiety level of COVID-19 patients during the isolation period.', 'detailedDescription': 'This is a randomized controlled trial conducted between February 2021 and June 2021. Patients tested positive for Covid-19 with mild to moderate forms were randomized to Education (n=267) or control (n=269). The education group received a phone health education session on day 1 (D1) following the diagnosis. The three components of the health education intervention were an explanation of the coronavirus disease, what to do in the event of complications, and the recommended preventive measures. The two groups received a telephone evaluation of their Hospital Anxiety and Depression scores on (D1) and day seven D7 following the positive diagnosis. The primary outcome was the rate of anxiety reduction in each group at D7 based on a HAD-A score ≥ 8. Secondary outcomes were the rate of anxiety reduction at D7 based on a HAD-A score ≥ 11, the percentage of people complying with isolation and the scores of adherence to preventive measures during the isolation in each group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with Covid-19 after positive PCR or positive antigen rapid test, over 18 years of age, who did not require hospitalization\n\nExclusion Criteria:\n\n* Patients not reachable at the first day phone call of the diagnosis and patients unable to answer the telephone questionnaire due to their cognitive state.'}, 'identificationModule': {'nctId': 'NCT05715593', 'briefTitle': 'The Effectiveness of a Health Education Intervention to Reduce Anxiety in Quarantined COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Monastir'}, 'officialTitle': 'The Effectiveness of a Health Education Intervention to Reduce Anxiety in Quarantined COVID-19 Patients: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'UMONASTIR1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Education', 'interventionNames': ['Other: health education intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'health education intervention', 'type': 'OTHER', 'description': 'health education intervention', 'armGroupLabels': ['Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Monastir', 'country': 'Tunisia', 'facility': 'Fattouma Bourguiba University Hospital', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Monastir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Imen Zemni', 'investigatorAffiliation': 'University of Monastir'}}}}