Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT05636956
Status:
UNKNOWN
Last Update Posted:
2022-12-05
First Post:
2022-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Education and Counseling Program on Patients With CIEDs and Low HL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D001519', 'term': 'Behavior'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-24', 'studyFirstSubmitDate': '2022-11-16', 'studyFirstSubmitQcDate': '2022-11-24', 'lastUpdatePostDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline knowledge level', 'timeFrame': 'Before education', 'description': 'CIEDs knowledge scale score of patients'}, {'measure': 'Change in knowledge level', 'timeFrame': 'At first month after education', 'description': 'CIEDs knowledge scale score of patients'}, {'measure': 'Change in knowledge level', 'timeFrame': 'At third month after education', 'description': 'CIEDs knowledge scale score of patients'}, {'measure': 'Change in knowledge level', 'timeFrame': 'At sixth month after education', 'description': 'CIEDs knowledge scale score of patients'}, {'measure': 'Baseline daily life activities', 'timeFrame': 'Before education', 'description': 'Duke Activity Index score of patients'}, {'measure': 'Change in daily life activities', 'timeFrame': 'At first month after education', 'description': 'Duke Activity Index score of patients'}, {'measure': 'Change in daily life activities', 'timeFrame': 'At third month after education', 'description': 'Duke Activity Index score of patients'}, {'measure': 'Change in daily life activities', 'timeFrame': 'At sixth month after education', 'description': 'Duke Activity Index score of patients'}, {'measure': 'Baseline health literacy level', 'timeFrame': 'Before education', 'description': 'Health Literacy Survey European Questionnaire 16 score of patients'}, {'measure': 'Change in health literacy level', 'timeFrame': 'At first month after education', 'description': 'Health Literacy Survey European Questionnaire 16 score of patients'}, {'measure': 'Change in health literacy level', 'timeFrame': 'At third month after education', 'description': 'Health Literacy Survey European Questionnaire 16 score of patients'}, {'measure': 'Change in health literacy level', 'timeFrame': 'At sixth month after education', 'description': 'Health Literacy Survey European Questionnaire 16 score of patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arrhythmias, Cardiac', 'Heart Failure', 'Health Knowledge, Attitudes, Practice']}, 'descriptionModule': {'briefSummary': 'The goal of this RCT (randomized controlled trial) is to investigate the effect of education and counseling program that researches developed on patients with cardiac implantable electronic devices (CIEDs) and low health literacy.\n\nThe main questions are; Is there a difference between the health literacy scores of intervention and control groups after education and counseling program? Is there a difference between the CIEDs knowledge scores of intervention and control groups after education and counseling program? Is there a difference between the daily life activity scores of intervention and control groups after education and counseling program?\n\nResearches offer an education and counseling program about living with CIEDs to patients that having CIEDs for the first time. Participants answers questions in Health Literacy Survey European Questionnaire 16, cardiac implantable electronic devices knowledge scale (researches developed) and Duke Activity Index before education and counseling program, at first month, third month and sixth month after implantation.\n\nReseraches compare scores between intervention and control groups, also different times in same groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* no communication problems in Turkish\n* implanted any type of CIED for the first time\n* having low score of HLS EU Q16\n* willingness to participate in the study\n\nExclusion Criteria:\n\n* Not literate\n* having vision or hearing problem\n* having psychiatric and cognitive impairment'}, 'identificationModule': {'nctId': 'NCT05636956', 'briefTitle': 'Education and Counseling Program on Patients With CIEDs and Low HL', 'organization': {'class': 'OTHER', 'fullName': 'Dokuz Eylul University'}, 'officialTitle': 'The Effect of Education and Counseling Program on Patients With Cardiac Implantable Electronic Devices and Low Health Literacy', 'orgStudyIdInfo': {'id': '2018/16-34'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients who receive education and counseling program', 'description': 'Patients with CIEDs and low health literacy received education and counseling program by researchers.', 'interventionNames': ['Other: Education and Counseling Program']}, {'type': 'NO_INTERVENTION', 'label': 'Patients who receive clinical routine care', 'description': 'Patients with CIEDs and low health literacy received only clinical routine care.'}], 'interventions': [{'name': 'Education and Counseling Program', 'type': 'OTHER', 'otherNames': ['Education and counseling program about living with CIEDs.'], 'description': 'Researches created an education and counseling program. In this context, patients receive an one hour education. Education program consist of face-to-face informing and teach-back method. At the end of the face-to-face informing, researchers give a comicbook about instructions of living with CIEDs as a written material. After discharge, researches follow-up patients with phone calls. In the context of phone calls researches continue to informing patients, remind related instructions for that time and answer questions of patients. Patients are allowed to reach reserarches any time if they have any concern or question. This program lasts for six months.', 'armGroupLabels': ['Patients who receive education and counseling program']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Balçova', 'state': 'İzmir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Merve Erunal, MSc', 'role': 'CONTACT', 'email': 'erunalmm@gmail.com', 'phone': '+905544635942'}], 'facility': 'Merve Erunal', 'geoPoint': {'lat': 38.39201, 'lon': 27.04258}}], 'centralContacts': [{'name': 'Merve Erünal', 'role': 'CONTACT', 'email': 'erunalmm@gmail.com', 'phone': '+905544635942'}, {'name': 'Hatice Mert', 'role': 'CONTACT', 'email': 'hatice.mert@deu.edu.tr', 'phone': '+092324124786'}], 'overallOfficials': [{'name': 'Merve Erünal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dokuz Eylul University Faculty of Nursing'}, {'name': 'Hatice Mert', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dokuz Eylul University Faculty of Nursing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dokuz Eylul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant, MSc., PhD(c).', 'investigatorFullName': 'Merve Erunal', 'investigatorAffiliation': 'Dokuz Eylul University'}}}}