Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 11:34 PM
Study NCT ID:
NCT03963934
Status:
UNKNOWN
Last Update Posted:
2019-10-21
First Post:
2019-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of a Program on a Nurse-led Telephone 6-month-follow-up for Uncontrolled Hypertensive Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, monocentric, open, pilot study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-17', 'studyFirstSubmitDate': '2019-05-23', 'studyFirstSubmitQcDate': '2019-05-24', 'lastUpdatePostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of women who completed all telephone follow-ups and came to the final visit at 6 months.', 'timeFrame': '6 months', 'description': 'The goal of recruitment in 6 months will be 20 women and the goal of the program finalization will be of at least 80% of patients (16 patients).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nurse-led management', 'Home blood pressure', 'Nurse-led telephone follow-up'], 'conditions': ['Arterial Hypertension', 'Medication Nonadherence']}, 'descriptionModule': {'briefSummary': 'This study evaluate the feasibility of a 6-month personalized support program for hypertensive and non-observant women, led by nurses by telephone follow-up.', 'detailedDescription': 'The program includes 2 themes:\n\n1. "Realizing my blood pressure self-measurement" according to the recommendations\n2. "Optimizing my compliance": understand the antihypertensive treatment, identify the brakes and the levers when taking medication, organize the treatment taking\n\nVisits :\n\n1. Inclusion visit :\n\n * Collection of consent by the nurse\n * Verification of inclusion and non-inclusion criteria : measurement of compliance with a scale for each antihypertensive treatment and BP measurement\n * Data collection and goal setting\n * Urine collection for dosing anti-hypertension drugs\n * Delivery of the schedule of telephone visits that were determined with the patient\n2. Implementation of personalized support with the following steps :\n\n * Data collection : evaluate knowledge and its potential as a patient, identify his needs\n * Determination of objectives : define the objectives of the program in each theme with the patient according to the collection of data Implementation of personalized support\n * 7 telephone interviews of 20 to 30 minutes use of specific teaching tools and materials by thematic assessment of achievements, validation of objectives\n\n Evaluation of the accompaniment:\n\n \\- assessment at the final visit\n3. Final visit at 6-month : Same as the inclusion visit with assessment of the support and questionnaire to assess the patient satisfaction level.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Woman ≥ 18 to 79 years old,\n* Hypertensive and treated with antihypertensive drug(s)\n* Unsatisfactory compliance for at least one of her antihypertensive treatment with a score below 80% at the medication adherence scale\n* Uncontrolled Blood Pressure (BP) : systolic BP equals to ou greater than140 and / or diastolic BP equals to ou greater than 90 mmHg at inclusion visit\n* Inform consent signed\n* Affiliation to a French social security scheme or beneficiary of such a scheme\n\nExclusion Criteria:\n\n* Patient with a history of cardio or cerebrovascular disease in the last 6 months (Stroke or Transient Ischemic Attack, myocardial infarction, heart failure)\n* Patient with kidney failure requiring dialysis\n* Patient with cognitive pathology: dementia, ... etc.\n* Patient with type I diabetes\n* Unreachable patient by phone or foreseeable inability or unwillingness to comply with study follow-up\n* Patient who does not understand and does not speak French'}, 'identificationModule': {'nctId': 'NCT03963934', 'acronym': 'PreDynamiques', 'briefTitle': 'Feasibility of a Program on a Nurse-led Telephone 6-month-follow-up for Uncontrolled Hypertensive Women', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Feasibility of a Program on a Nurse-led Telephone 6-month-follow-up for Uncontrolled Hypertensive Women: a Patient-tailored Intervention', 'orgStudyIdInfo': {'id': '2019-A01921-56'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Women with uncontrolled hypertension', 'description': 'Women with uncontrolled hypertension and unsatisfactory medication adherence', 'interventionNames': ['Other: Program on a nurse-led telephone 6-month-follow-up for uncontrolled hypertensive women: a patient-tailored intervention']}], 'interventions': [{'name': 'Program on a nurse-led telephone 6-month-follow-up for uncontrolled hypertensive women: a patient-tailored intervention', 'type': 'OTHER', 'description': 'Implementation of personalized support: The accompaniment includes 7 telephone interviews for 6 months (understanding the antihypertensive treatment, identifying the brakes and the levers when taking medication, organizing the treatment taking, making the home blood pressure)', 'armGroupLabels': ['Women with uncontrolled hypertension']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Edith DAUCHY, RN', 'role': 'CONTACT', 'email': 'e.dauchy@chru-nancy.fr', 'phone': '33 3 83 15 73 13'}], 'overallOfficials': [{'name': 'Edith DAUCHY, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU Nancy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}