Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-25 @ 2:58 PM
Study NCT ID:
NCT03599050
Status:
COMPLETED
Last Update Posted:
2022-02-14
First Post:
2018-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Training in the 21st Century: Using Virtual Role-Plays to Improve Nurse Communication for Medication Adherence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-28', 'studyFirstSubmitDate': '2018-07-17', 'studyFirstSubmitQcDate': '2018-07-18', 'lastUpdatePostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility measured by documenting total available and eligible nurses and patients approached to enroll 1 participant through final study visit', 'timeFrame': '6 Months'}, {'measure': 'Acceptability measured by % of nurses who complete the simulation', 'timeFrame': '6 Months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['High Blood Pressure', 'Hypertension']}, 'descriptionModule': {'briefSummary': "This study will utilize a three-phase approach that is informed by a theory-driven implementation framework to: 1) conduct a needs analysis in order to identify individual-, health care team-, and practice-level barriers and facilitators to conducting adherence counseling in safety-net primary care practices; 2) develop a virtual communication simulation designed to improve the quality of adherence counseling by allowing nurses repeated opportunities to practice discussing medication adherence with virtual patients; and 3) conduct a pilot study to evaluate the feasibility, acceptability and preliminary efficacy of the simulation on changes in: a) nurses' collaborative communication skills, b) medication adherence, and c) reduction in BP in a sample of 20 patients with uncontrolled hypertension (HTN) who are non-adherent to their medications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PCPs and nurses will be enrolled if they fulfill the following criteria:\n\n 1. male or female healthcare provider (MD/DO, NP, and Registered Nurse) practicing at the clinic\n 2. age 18 years or older.\n\nNo exclusions will be made based on provider race/ethnic origin. We will oversample males to examine differential communication skills based on gender.\n\n* Patient eligibility criteria include:\n\n 1. receiving care at the participating clinic\n 2. having uncontrolled HTN (BP\\>140/90 mmHg) at two visits in the past year\n 3. being prescribed at least one antihypertensive medication and are non-adherent\n 4. are ≥age 18 years\n 5. fluent in English\n\nExclusion Criteria:\n\n* Unable to give consent\n* Have a diagnosis of cognitive dysfunction or significant psychiatric comorbidity,\n* Participating in another HTN-related study.'}, 'identificationModule': {'nctId': 'NCT03599050', 'briefTitle': 'Training in the 21st Century: Using Virtual Role-Plays to Improve Nurse Communication for Medication Adherence', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Training in the 21st Century: Using Virtual Role-Plays to Improve Nurse Communication for Medication Adherence', 'orgStudyIdInfo': {'id': '18-01003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Communication Simulation', 'description': 'Nurses will use simulation over 12 weeks while fidelity is monitored using the NIH Behavior Change Consortium Treatment Fidelity Guidelines.', 'interventionNames': ['Behavioral: Audiotaped Counseling Session']}], 'interventions': [{'name': 'Audiotaped Counseling Session', 'type': 'BEHAVIORAL', 'description': 'Patients and nurses will complete audio taped counseling session at least 3 months following the baseline visit. Patients will rate quality of nurse communication skills', 'armGroupLabels': ['Communication Simulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Antoinette Schoenthaler, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 3 months and ending 5 years following article publication.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Will be used for secondary data analysis approved by the investigator', 'accessCriteria': 'Researchers who provide a methodologically sound proposal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}