Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-02-28 @ 10:01 PM
Study NCT ID:
NCT03203018
Status:
COMPLETED
Last Update Posted:
2019-01-23
First Post:
2017-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health Literacy and Cardiovascular Knowledge Workshop in Women From Disadvantaged Communities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003142', 'term': 'Communication'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a pre/post study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 407}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-22', 'studyFirstSubmitDate': '2017-06-26', 'studyFirstSubmitQcDate': '2017-06-28', 'lastUpdatePostDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in preparation for doctor's visit", 'timeFrame': 'Before intervention and three months after intervention', 'description': "Women complete self report survey indicating if whether or not they prepared for their doctor's visit, whether or not they prepared a list of questions for their doctor's visit, a list of symptoms, a list of medications, and their medical background information"}], 'secondaryOutcomes': [{'measure': 'Change in cardiovascular disease knowledge', 'timeFrame': 'At baseline and three month after intervention', 'description': "Cardiovascular disease knowledge will be assessed through a self report questionnaire based on the American Heart Association's Cardiovascular disease knowledge survey items"}, {'measure': 'Change in perceived efficacy in patient-physician interaction', 'timeFrame': 'At baseline and three month after intervention', 'description': 'Perceived efficacy in patient-physician interaction (PEPPI) will be assessed via PEPPI self report scale (Maly, Frank, Marshall, Diametteo, Reuben, 1998)'}, {'measure': 'Change in knowledge of health measures', 'timeFrame': 'At baseline and three month after intervention', 'description': 'Knowledge of health measures will be assessed through self report questionnaire'}, {'measure': 'Change in reading blood test results', 'timeFrame': 'At baseline and three month after intervention', 'description': 'Reading blood test results will be assessed through self report questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiovascular Diseases (CVD)', 'Community-based intervention', 'Socio-economic status (SES)', 'Health literacy (HL)'], 'conditions': ['Health Literacy', 'Communication']}, 'referencesModule': {'references': [{'pmid': '19372101', 'type': 'BACKGROUND', 'citation': 'Peerson A, Saunders M. Health literacy revisited: what do we mean and why does it matter? Health Promot Int. 2009 Sep;24(3):285-96. doi: 10.1093/heapro/dap014. Epub 2009 Apr 16.'}, {'pmid': '16100861', 'type': 'BACKGROUND', 'citation': 'Safeer RS, Keenan J. Health literacy: the gap between physicians and patients. Am Fam Physician. 2005 Aug 1;72(3):463-8.'}, {'pmid': '25009856', 'type': 'BACKGROUND', 'citation': 'Institute of Medicine (US) Committee on Health Literacy; Nielsen-Bohlman L, Panzer AM, Kindig DA, editors. Health Literacy: A Prescription to End Confusion. Washington (DC): National Academies Press (US); 2004. Available from http://www.ncbi.nlm.nih.gov/books/NBK216032/'}, {'pmid': '12038721', 'type': 'BACKGROUND', 'citation': 'Williams MV, Davis T, Parker RM, Weiss BD. The role of health literacy in patient-physician communication. Fam Med. 2002 May;34(5):383-9.'}, {'pmid': '15610334', 'type': 'BACKGROUND', 'citation': 'Dewalt DA, Berkman ND, Sheridan S, Lohr KN, Pignone MP. Literacy and health outcomes: a systematic review of the literature. J Gen Intern Med. 2004 Dec;19(12):1228-39. doi: 10.1111/j.1525-1497.2004.40153.x.'}, {'pmid': '9844076', 'type': 'BACKGROUND', 'citation': 'Baker DW, Parker RM, Williams MV, Clark WS. Health literacy and the risk of hospital admission. J Gen Intern Med. 1998 Dec;13(12):791-8. doi: 10.1046/j.1525-1497.1998.00242.x.'}, {'pmid': '18360559', 'type': 'BACKGROUND', 'citation': 'Martin LR, Williams SL, Haskard KB, Dimatteo MR. The challenge of patient adherence. Ther Clin Risk Manag. 2005 Sep;1(3):189-99.'}, {'pmid': '31189377', 'type': 'DERIVED', 'citation': 'Greenberg KL, Leiter E, Donchin M, Agbaria N, Karjawally M, Zwas DR. Cardiovascular health literacy and patient-physician communication intervention in women from disadvantaged communities. Eur J Prev Cardiol. 2019 Nov;26(16):1762-1770. doi: 10.1177/2047487319853900. Epub 2019 Jun 12.'}]}, 'descriptionModule': {'briefSummary': "The current health literacy (HL) pilot intervention was designed through focus groups with women in low socio-economic status (SES) communities. The primary HL issue identified was communication challenges at doctors' visits. As a unique HL intervention tailored to the participants' preferences, this intervention can serve as a model for improving HL in similar communities worldwide.\n\nObjectives include increasing the percentage of women who utilize patient-doctor communication skills and increasing their cardiovascular disease (CVD) knowledge. A unique HL intervention tailored to the participants' preferences was designed which consisted of three workshops conducted in municipality-sponsored women's groups in low SES Jerusalem communities. Questionnaires were completed before and three months after the intervention. The study answers the following: Can HL workshops improve patient-doctor communication skills and CVD knowledge in low SES women?", 'detailedDescription': "The current health literacy (HL) pilot intervention was designed through focus groups with women in low socio-economic status (SES) communities. The primary HL issue identified was communication challenges at doctors' visits. As a unique HL intervention tailored to the participants' preferences, this intervention can serve as a model for improving HL in similar communities worldwide.\n\nObjectives include increasing the percentage of women who utilize patient-doctor communication skills, prepare for their doctor's visit, and increase their cardiovascular disease (CVD) knowledge.\n\nIn order to accomplish these objectives, a unique HL intervention tailored to the participants' preferences was designed which consisted of three workshops conducted in municipality-sponsored women's groups in low SES Jerusalem communities. This intervention consisted of a three consecutive weekly workshop conducted in women's support groups in disadvantaged communities in Jerusalem. The workshop includes women's heart health sessions, as well as sessions about how to make the most of a doctor's visit, which includes role play and teach back method practice. A self-admitted questionnaire regarding CVD and relevant HL knowledge and behaviors was completed at the beginning of the intervention, and three months after the last session.\n\nThis study answers the question of whether a three session HL workshop for women can successfully raise their CVD knowledge and awareness, as well as change behaviors of women in terms of preparing for doctor's visits."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women from Jerusalem\n* Hebrew and Arabic speakers\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03203018', 'briefTitle': 'Health Literacy and Cardiovascular Knowledge Workshop in Women From Disadvantaged Communities', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Health Literacy and Cardiovascular Knowledge Workshop in Women From Disadvantaged Communities', 'orgStudyIdInfo': {'id': '235HLT-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Women participating in HL intervention', 'description': 'Groups of women from disadvantaged communities will participate in a three session health literacy workshop', 'interventionNames': ['Behavioral: Interactive workshop based on community specific needs']}], 'interventions': [{'name': 'Interactive workshop based on community specific needs', 'type': 'BEHAVIORAL', 'description': 'Intervention components will include lecture on women\'s CVD, workshop on how to prepare for a doctor\'s visit, patient\'s rights and patient-doctor communication skills, and a "know your numbers" workshop, including understanding blood test results.', 'armGroupLabels': ['Women participating in HL intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Organization, Jerusalem, Israel', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Donna Zwas, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Medical Organization'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Linda Joy Pollin Cardiovascular Wellness Center for Women', 'investigatorFullName': 'Donna R Zwas', 'investigatorAffiliation': 'Hadassah Medical Organization'}}}}