Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-28 @ 12:03 PM
Study NCT ID:
NCT06406192
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-19
First Post:
2024-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of FOR-Care Model on Preventive Medicine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001827', 'term': 'Body Height'}], 'ancestors': [{'id': 'D049628', 'term': 'Body Size'}, {'id': 'D001837', 'term': 'Body Weights and Measures'}, {'id': 'D001824', 'term': 'Body Constitution'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D000067029', 'term': 'Physical Appearance, Body'}, {'id': 'D000886', 'term': 'Anthropometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006128', 'term': 'Growth'}, {'id': 'D048788', 'term': 'Growth and Development'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2024-04-28', 'studyFirstSubmitQcDate': '2024-05-05', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants with Documented On-Site Blood Pressure, Height, and Weight Recordings', 'timeFrame': 'From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward', 'description': 'The documentation of on-site blood pressure, height, and weight recordings'}, {'measure': 'Rate of Newly-Diagnosed Hypertension', 'timeFrame': 'From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward', 'description': 'Assessing whether the improvement in documentation of on-site blood pressure, height, and weight recordings increases the diagnosis rates of hypertension.'}, {'measure': 'Rate of Newly-Diagnosed Diabetes Mellitus', 'timeFrame': 'From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward', 'description': 'Assessing whether the improvement in documentation of on-site blood pressure, height, and weight recordings increases the diagnosis rates of diabetes mellitus.'}], 'secondaryOutcomes': [{'measure': 'Office Blood Pressure in Hypertensionsive Patients', 'timeFrame': 'From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward', 'description': 'Assessing whether the intervention affects clinical indicators of hypertension'}, {'measure': 'Home Blood Pressure in Hypertensionsive Patients', 'timeFrame': 'From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward', 'description': 'Assessing whether the intervention affects clinical indicators of hypertension'}, {'measure': 'Estimated Glomerular Filtration Rate', 'timeFrame': 'From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward', 'description': 'Assessing whether the intervention affects renal function (all patients)'}, {'measure': 'Urinary Microalbumin Excretion', 'timeFrame': 'From enrollment to the next follow-up visit at either 12 weeks or 24 weeks afterward', 'description': 'Assessing whether the intervention affects renal function (all patients)'}, {'measure': 'Mortality Rate', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed up to 36 months', 'description': 'Assessing whether the intervention affects longterm survival status'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Body weight', 'Diabetes mellitus', 'Cluster randomized trial', 'Family medicine', 'Outpatient department', 'Preventive medicine'], 'conditions': ['Diabetes Mellitus', 'Body Weight', 'Family Medicine', 'Hypertension', 'Preventive Medicine']}, 'descriptionModule': {'briefSummary': 'This study aims to address the prevalence of undiagnosed hypertension and diabetes by assessing the impact of the FOR-Care model on preventive medicine. The model focuses on improving the documentation of blood pressure, height, and weight in outpatient settings. Through a cluster randomized trial at National Taiwan University Hospital, clinics will either implement the FOR-Care model or continue with usual care. The trial will evaluate the effectiveness of the intervention in documenting these measurements and its impact on diagnosing hypertension and diabetes. The outcomes will provide valuable insights into enhancing preventive medicine and improving care for chronic diseases.', 'detailedDescription': 'Background: The prevalence of undiagnosed hypertension and diabetes among adults is considerable. For those already diagnosed with hypertension and diabetes, monitoring blood pressure and controlling body weight are recognized as essential methods for risk assessment. However, in outpatient settings, there is still room for improvement in the on-site documentation of blood pressure, height, and weight.\n\nObjective: This cluster randomized trial (CRT) will assess the effects of preventive medicine following the implementation of the FOR-Care model, a technique designed for facilitating on-site recordings of office blood pressure, height, and weight.\n\nMethods: The investigators will conduct a pragmatic CRT at the outpatient clinics of the Department of Family Medicine, National Taiwan University Hospital. A total of 42 clinics with over 15 patients will be randomized into two groups. The intervention group will adopt a FOR-Care model, required to measure and record blood pressure, height, and weight before consultations; while the control group receives usual care. The protected medical information will be accessed through the National Taiwan University Hospital Integrative Medical Database (NTUH-iMD). The quality improvement outcome is documentation of on-site blood pressure, height, and weight recordings of both groups at 12 and 24 weeks (cluster-level parameter). The primary preventive medicine outcome is newly diagnosed hypertension and diabetes mellitus (individual-level parameter). The secondary preventive medicine outcomes are clinical indicators of hypertension and diabetes mellitus in those with these diagnoses (individual-level parameters).\n\nExpected Outcomes: The results of this pragmatic CRT will shed new insight into preventive medicine and quality of care in the management of common chronic diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Cluster-level inclusion criteria:\n\n* clinic sessions with at least 15 patients, but fewer than 40 patients\n\nCluster-level exclusion criteria:\n\n* travel, hospice, vaccination, or health examination clinics\n* special-appointed clinics\n\nPatient-level exclusion criteria\n\n* patients aged less than 18\n* patients with active catastrophic illness or terminal malignancies\n* patients with major adverse cardiac events within 3 months before the index dates'}, 'identificationModule': {'nctId': 'NCT06406192', 'briefTitle': 'Effects of FOR-Care Model on Preventive Medicine', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Effects of Facilitating On-Site Recordings of Office Blood Pressure, Height, and Weight on Preventive Medicine - A Pragmatic Cluster Randomized Trial', 'orgStudyIdInfo': {'id': '202402048RIND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No Intervention Group', 'description': "This group does not specifically encourage or interfere with physicians' original methods of inquiry or patients providing bodily examination data."}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'This group encourages physicians to actively inquire or patients to voluntarily provide physical examination data during consultations.', 'interventionNames': ['Diagnostic Test: Height, Weight, and Blood Pressure Measurement Procedures Improvement']}], 'interventions': [{'name': 'Height, Weight, and Blood Pressure Measurement Procedures Improvement', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['FOR-Care Model'], 'description': 'In the intervention group, the investigators improve the process of measuring blood pressure, height, and weight, requiring timely recording of these measurements. The intervention includes:\n\ni. Enlisting the assistance of nurses and volunteers to improve the accessibility of measurement environments and provide guidance on instrument operation.\n\nii. Using paper reminders at check-in stations to prompt patients to complete blood pressure and weight recordings before entering examination rooms; providing paper for recording if patients forget their health insurance cards.\n\niii. Providing alcohol and hand wipes outside examination rooms for disinfecting measurement instruments.\n\niv. Promoting the recording mode outside the check-in station.\n\nv. Ensuring that physicians or nurses in examination rooms accurately record measurements in the medical order system.\n\nvi. Encouraging patients to ask physicians during consultations, "Is my blood pressure and weight okay?"', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Chien-Hsieh Chiang, MD, MPH, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Family MedicineClinical Assistant Professor, Department of Family Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'However, de-identified data regarding the pre-defined outcomes or relevant characteristics could be available per request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}