Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT04475367
Status:
UNKNOWN
Last Update Posted:
2020-07-21
First Post:
2020-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of an APP in Improving Treatment Adherence in Hypertensive Patients in Hypertension Ambulatory
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000267', 'term': 'Tissue Adhesions'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'blind research assistant'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The participants will be randomized into 2 intervention groups'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-07-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-18', 'studyFirstSubmitDate': '2020-05-29', 'studyFirstSubmitQcDate': '2020-07-16', 'lastUpdatePostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure value', 'timeFrame': '15 minutes', 'description': 'systolic Blood pressure and dyastolic Blood pressure'}], 'secondaryOutcomes': [{'measure': 'Morisky scale', 'timeFrame': '15 minutes', 'description': 'Medication adherence. The Morisky scale condition and medication specific assessment: 1) measures the level of adherence an medication, 2) measures the severity of Major Depressive Disorder, a determinant of non-adherence 3) identifies why the patient is not taking their medication, 4) determines the risk between non-adherence to BP measures of disease control. 0-1 = Low motivation; 2-3 = High motivation / 0-1 = Low knowledge; 2-3 = High knowledge'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['software', 'hypertension', 'technology'], 'conditions': ['Blood Pressure', 'Adhesion']}, 'descriptionModule': {'briefSummary': 'Brief Summary: Through the App, the user will have the opportunity to connect directly with the health professional, clarify doubts and manage the treatment of their hypertension.', 'detailedDescription': 'To evaluate treatment adherence and blood pressure reduction, through the HiperCross App, between two groups of hypertensive patients in a Hypertension Public Ambulatory in Porto Alegre.\n\nThe investigators hope to identify better adherence to treatment, as well as a significant reduction in blood pressure, all of these results will be better evaluated using the HiperCross application.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hypertensive patients admitted to the hypertension clinic at Instituto de Cardiologia\n* older 18 years\n\nExclusion Criteria:\n\n* Patients without a mobile phone compatible with the App'}, 'identificationModule': {'nctId': 'NCT04475367', 'briefTitle': 'Evaluation of the Effect of an APP in Improving Treatment Adherence in Hypertensive Patients in Hypertension Ambulatory', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Cardiologia do Rio Grande do Sul'}, 'officialTitle': 'Evaluation of the Effect of an APP in Improving Treatment Adherence in Hypertensive Patients in Hypertension Ambulatory', 'orgStudyIdInfo': {'id': '5701-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hypertensive patients using HyperCrossApp', 'description': 'Interdisciplinary health care\n\n\\+ HyperCross App', 'interventionNames': ['Other: App hypercross group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'hypertensive patients without using HyperCrossApp', 'description': 'Interdisciplinary health care', 'interventionNames': ['Other: without App hypercross group']}], 'interventions': [{'name': 'App hypercross group', 'type': 'OTHER', 'description': 'hypertensive patients using HyperCrossApp', 'armGroupLabels': ['hypertensive patients using HyperCrossApp']}, {'name': 'without App hypercross group', 'type': 'OTHER', 'description': 'Interdisciplinary health care', 'armGroupLabels': ['hypertensive patients without using HyperCrossApp']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ana Paula Reis, Nurse', 'role': 'CONTACT', 'email': 'areis9874@gmail.com', 'phone': '+555132303600'}, {'name': 'Bruna Eibel, PhD', 'role': 'CONTACT', 'email': 'brunaeibel@gmail.com', 'phone': '+555132303600'}], 'overallOfficials': [{'name': 'Bruna Eibel, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Post Graduation professor - Cardiology Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Cardiologia do Rio Grande do Sul', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nurse Specialist', 'investigatorFullName': 'Ana Paula Reis', 'investigatorAffiliation': 'Instituto de Cardiologia do Rio Grande do Sul'}}}}