Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 11:11 PM
Study NCT ID:
NCT04824560
Status:
COMPLETED
Last Update Posted:
2024-11-25
First Post:
2021-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating the Effect of an Evidence-Based One Page With Supplemental Visual Aids on the Knowledge and Perceptions of Blood Pressure Management Among Adults With Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'asible@salud.unm.edu', 'phone': '505-272-7630', 'title': 'Alexandra Herman', 'organization': 'University of New Mexico College of Pharmacy'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'After enrollment, packet was mailed to participant and future phone call time frames set up to be able to call the participants back for an initial call to ensure packet received within one week of enrollment; with follow-up at 4 weeks after enrollment, 8 weeks after enrollment, and then a final phone call to ensure information would be mailed back at up to 4 weeks after the final phone call.', 'description': 'As the intervention was a survey and phone call, no serious adverse events were expected and none were reported by participants within one week; 4 weeks, or 8 weeks,or when contacted to ensure information would be mailed back at up to 4 weeks after the final phone call (within a maximum of 12 weeks of enrollment).', 'eventGroups': [{'id': 'EG000', 'title': 'BP Education', 'description': 'All participants enrolled receive blood pressure education.\n\nBlood pressure education: One page teaching protocol performed by pharmacy students; phone follow-up', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pre & Post Survey & Knowledge Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BP Education', 'description': "All participants enrolled receive blood pressure education; measured change in participant's knowledge of blood pressure management as measured by a pre- and post-test of 10 multiple-choice questions"}], 'classes': [{'title': 'Pre-Test Knowledge Score', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '100'}]}]}, {'title': 'Post-Test Knowledge Score', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': "change in participant's knowledge of blood pressure management as measured by a pre- and post-test of 10 multiple-choice questions", 'unitOfMeasure': 'percentage of questions answered correct', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'BP Education Helpfulness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BP Education', 'description': 'All participants enrolled receive blood pressure education.\n\nBlood pressure education: One page teaching protocol performed by pharmacy students; phone follow-up'}], 'classes': [{'title': 'Helpful - Yes', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Helpful - NO', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': "All participants enrolled receive blood pressure education; measured patient's perceived helpfulness of educational one-page handout in a post-survey", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'BP Education - Change in Confidence in Managing Disease State (Pre & Post Survey)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BP Education', 'description': 'All participants enrolled receive blood pressure education.\n\nBlood pressure education: One page teaching protocol performed by pharmacy students; phone follow-up'}], 'classes': [{'title': 'Pre-Survey', 'categories': [{'title': 'Confident in ability to manage disease state - pre-survey - Yes', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Confident in ability to manage disease state - pre-survey - No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Post-Survey', 'categories': [{'title': 'Confident in ability to manage disease state - pre-survey - Yes', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Confident in ability to manage disease state - pre-survey - No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': "change in participant's confidence in managing disease state as measured by pre \\& post survey", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BP Education', 'description': 'All participants enrolled receive blood pressure education.\n\nBlood pressure education: One page teaching protocol performed by pharmacy students; phone follow-up'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'BP Education', 'description': 'All participants enrolled receive blood pressure education.\n\nBlood pressure education: One page teaching protocol performed by pharmacy students; phone follow-up'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000', 'lowerLimit': '36', 'upperLimit': '72'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'categories': [{'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Hispanic', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'A total of 5 participants received the information, participated in follow-up phone calls, and returned all of their information in the provided SASE to the clinic.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-10', 'size': 426235, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-06T01:38', 'hasProtocol': True}, {'date': '2020-06-12', 'size': 544169, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-03-12T12:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2021-03-09', 'resultsFirstSubmitDate': '2024-01-07', 'studyFirstSubmitQcDate': '2021-03-26', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-08', 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre & Post Survey & Knowledge Test', 'timeFrame': '8 weeks', 'description': "change in participant's knowledge of blood pressure management as measured by a pre- and post-test of 10 multiple-choice questions"}], 'secondaryOutcomes': [{'measure': 'BP Education Helpfulness', 'timeFrame': '8 weeks', 'description': "All participants enrolled receive blood pressure education; measured patient's perceived helpfulness of educational one-page handout in a post-survey"}, {'measure': 'BP Education - Change in Confidence in Managing Disease State (Pre & Post Survey)', 'timeFrame': '8 weeks', 'description': "change in participant's confidence in managing disease state as measured by pre \\& post survey"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate changes in patient knowledge of blood pressure management and perceptions of making lifestyle changes to manage their blood pressure after implementation of an evidence-based one-page teaching protocol with supplemental handouts and optional use of suggested apps and web sites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults from 18 to 75 years old\n* Ability to self-consent\n* English-speaking\n* Able to read/write English\n* Currently prescribed at least one medication for treatment of essential primary hypertension\n\nExclusion Criteria:\n\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Pregnant women\n* Prisoners'}, 'identificationModule': {'nctId': 'NCT04824560', 'briefTitle': 'Evaluating the Effect of an Evidence-Based One Page With Supplemental Visual Aids on the Knowledge and Perceptions of Blood Pressure Management Among Adults With Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'Evaluating the Effect of an Evidence-Based One Page With Supplemental Visual Aids on the Knowledge and Perceptions of Blood Pressure Management Among Adults With Hypertension', 'orgStudyIdInfo': {'id': '20-458'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'BP Education', 'description': 'All participants enrolled receive blood pressure education.', 'interventionNames': ['Behavioral: Blood pressure education']}], 'interventions': [{'name': 'Blood pressure education', 'type': 'BEHAVIORAL', 'description': 'One page teaching protocol performed by pharmacy students; phone follow-up', 'armGroupLabels': ['BP Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87112', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Walgreens Store #6587', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Missouri-Columbia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}