Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2026-02-11 @ 9:28 PM
Study NCT ID:
NCT02249494
Status:
COMPLETED
Last Update Posted:
2015-03-19
First Post:
2014-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Application to Improve Nutritional Counseling Provided by Primary Care Physicians for Hypertension.
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D015596', 'term': 'Nutrition Assessment'}], 'ancestors': [{'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-18', 'studyFirstSubmitDate': '2014-09-23', 'studyFirstSubmitQcDate': '2014-09-24', 'lastUpdatePostDateStruct': {'date': '2015-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in score of knowledge and ability related to nutritional care.', 'timeFrame': '30 days', 'description': 'For each correct answer, participant will get one point on the knowledge test and for each incorrect answer will get 0. Thus, possible scores will range from 69 to 0. Data based on questions about the abilities will be summarized in a qualitative ranking.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nutritional Knowledge', 'Nutritional Counseling'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '38127014', 'type': 'DERIVED', 'citation': 'Gadenz SD, Harzheim E, Rados DRV, Castro SMJ, Drehmer M. Mobile Application Increased Nutrition Knowledge Among Brazilian Physicians. J Nutr Educ Behav. 2024 Feb;56(2):92-99. doi: 10.1016/j.jneb.2023.11.001. Epub 2023 Dec 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether the use of a mobile app could improve knowledge and practice in nutrition counseling performed by primary care physicians in Brazil.', 'detailedDescription': 'To optimize the nutritional care in the context of the limitations of available time and knowledge in medical practice, the present study proposes to develop a tool of nutritional guidelines for hypertension, easily accessible, based on evidence, and then evaluate its use among primary care physicians registered in a center telehealth. The use of the mobile application tool will aim to improve the nutritional counseling, helping with prevention of other chronic diseases in primary care context.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary care physicians registered in TelessaúdeRS (Center for Telehealth)\n* primary care physicians who use smartphone or tablet\n\nExclusion Criteria:\n\n* not to work in primary care'}, 'identificationModule': {'nctId': 'NCT02249494', 'briefTitle': 'Mobile Application to Improve Nutritional Counseling Provided by Primary Care Physicians for Hypertension.', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': 'Nutritional Recommendations for Hypertension: Development of Mobile Application for Improve Knowledge in Lifestyle Modification for Primary Care Physicians', 'orgStudyIdInfo': {'id': '14-0258'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Smartphone (mobile app) & telehealth', 'description': 'Participants will install and use a mobile application designed to provide nutritional recommendations for hypertensive patients. These recommendations will be based on the DASH diet guidelines appropriate to patient profile: consumption of whole grains, fruits, vegetables, milk or low fat dairy products, lean meats, poultry and fish, nuts, seeds and legumes, amount of fats, oils and sweets, as well as guidelines for salt intake and alcohol. The call service will be offered by the Center for Telehealth Rio Grande do Sul to answer clinic questions with qualified staff and in real time. All physicians who work in Primary Health Care in Brazil can use this call center when they have questions about diagnosis and management of their patients.', 'interventionNames': ['Other: telehealth', 'Other: nutritional counseling', 'Device: smartphone (mobile app)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'nutritional counseling & telehealth', 'description': 'Physicians who are enrolled for this group will continue performing routine nutritional counseling in their clinical practice. The call service will be offered by the Center for Telehealth Rio Grande do Sul to answer clinic questions with qualified staff and in real time. All physicians who work in Primary Health Care in Brazil can use this call service when they have questions about diagnosis and management of their patients.', 'interventionNames': ['Other: telehealth', 'Other: nutritional counseling']}], 'interventions': [{'name': 'telehealth', 'type': 'OTHER', 'description': 'Use the call service offered by the Center for Telehealth Rio Grande do Sul to answer clinic questions with qualified staff and in real time. All physicians who work in Primary Health Care in Brazil can call when they have questions about diagnosis and management of their patients.', 'armGroupLabels': ['Smartphone (mobile app) & telehealth', 'nutritional counseling & telehealth']}, {'name': 'nutritional counseling', 'type': 'OTHER', 'description': 'Performing routine nutritional counseling in their clinical practice', 'armGroupLabels': ['Smartphone (mobile app) & telehealth', 'nutritional counseling & telehealth']}, {'name': 'smartphone (mobile app)', 'type': 'DEVICE', 'description': 'Mobile app, designed to provide nutritional recommendations for hypertensive patients, will be use. The recommendations will be based on the DASH diet guidelines appropriate to the patient profile: consumption of whole grains, fruits, vegetables, milk or low fat dairy products, lean meats, poultry and fish, nuts, seeds and legumes, amount of fats, oils and sweets, as well as guidelines for salt intake and alcohol.', 'armGroupLabels': ['Smartphone (mobile app) & telehealth']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90430-090', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Núcleo de Telessaúde Técnico-Científico do Rio Grande do Sul. Universidade Federal do Rio Grande do Sul', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Erno Harzheim, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Rio Grande do Sul'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Federal University of Rio Grande do Sul', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}