Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-25 @ 1:11 PM
Study NCT ID:
NCT03596359
Status:
COMPLETED
Last Update Posted:
2018-07-23
First Post:
2018-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Teach-Back Method on Quality of Life in Heart Failure Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, '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': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-20', 'studyFirstSubmitDate': '2018-06-25', 'studyFirstSubmitQcDate': '2018-07-20', 'lastUpdatePostDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SF 36 questionnaire', 'timeFrame': 'Up to 48 hours', 'description': 'SF36 questionnaire was used to measuring the quality of life'}, {'measure': 'Demographic questionnaire', 'timeFrame': '24 hours', 'description': 'Demographic questionnaire was used to collect information'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Self Care', 'Heart Failure', 'Quality of Life', 'Teach-Back'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'This study determines effect of education with Teach-Back method in patients with Heart failure. In this randomized clinical trial, 70 patients with Heart failure hospitalized in year 2016-17 were selected and they were randomly divided into control group and test group.Self-care behaviors training with Teach-Back method within 15 to 45 minutes was done on the case group, and control group received routine treatment. Information have collected whit Demographic questionnaire and SF36 questionnaire before and after training. Data were analyzed by Spss version18 And there were analyzed by descriptive statistics and Chi-square, Independent T-test, Paired T-test and Co-variance tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 45 to 85\n* Heart failure diagnosed six months ago\n* The Ejection Fraction less than 45\n* Have reading and writing skills\n* Have perfect consciousness\n* Fluency in Persian\n\nExclusion Criteria:\n\n* Patient do not cooperate with researchers\n* The inability of each sample to continue cooperation during the study because of the problem or acute disease.'}, 'identificationModule': {'nctId': 'NCT03596359', 'briefTitle': 'Teach-Back Method on Quality of Life in Heart Failure Patients', 'organization': {'class': 'OTHER', 'fullName': 'Baqiyatallah Medical Sciences University'}, 'officialTitle': 'Effect of Self-care Education With Teach-Back Method on Quality of Life in Heart Failure Patients', 'orgStudyIdInfo': {'id': 'IR.BMSU.Rec.1394.144'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test group', 'description': 'Self-care behaviors training with Teach-Back method within 15 to 45 minutes was done on the Test group', 'interventionNames': ['Behavioral: Education with Teach-Back method']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'The control group received routine treatment', 'interventionNames': ['Other: Received routine treatment']}], 'interventions': [{'name': 'Education with Teach-Back method', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Test group']}, {'name': 'Received routine treatment', 'type': 'OTHER', 'armGroupLabels': ['Control group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baqiyatallah Medical Sciences University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohammad Sadegh Bagheri Baghdasht', 'investigatorAffiliation': 'Baqiyatallah Medical Sciences University'}}}}