Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-03-08 @ 5:06 AM
Study NCT ID:
NCT04558905
Status:
COMPLETED
Last Update Posted:
2022-09-28
First Post:
2020-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of a Hybrid Medical Care Model in the Rheumatoid Arthritis Patient-reported-outcomes Measures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This a non-inferiority and cross-over study, with a planned follow-up of 16 months, with 2 intervention arms:\n\nIntervention 1: Patients assigned to 6 months of usual medical care model, followed by 4 months of a control period, and finally 6 months of hybrid medical care model.\n\nIntervention 2: Patients assigned to 6 months of hybrid medical care model, followed by 4 months of a control period, and finally 6 months of usual medical care model.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-26', 'studyFirstSubmitDate': '2020-09-10', 'studyFirstSubmitQcDate': '2020-09-16', 'lastUpdatePostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rheumatoid arthritis patient´s disease activity', 'timeFrame': 'During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)', 'description': 'The disease activity measured by a RAPID-3 instrument'}, {'measure': 'Rheumatoid arthritis patient´s quality of life', 'timeFrame': 'During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)', 'description': 'Quality of life measured by a WHOQOL-BREF instrument'}, {'measure': "Rheumatoid arthritis patient's disability", 'timeFrame': 'During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)', 'description': 'Disability measured by a HAQ-DI instrument'}], 'secondaryOutcomes': [{'measure': 'Satisfaction with medical care', 'timeFrame': 'During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)', 'description': 'Questionnaire locally developed'}, {'measure': 'Patient´s adherence to medical care', 'timeFrame': 'During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)', 'description': 'Number of missed scheduled visits'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis'], 'conditions': ['Rheumatoid Arthritis', 'Telehealth']}, 'descriptionModule': {'briefSummary': 'The COVID-19 outbreak has affected health care of patients with rheumatic diseases; telemedicine might help to assist patients.\n\nThe primary objective is to determine if a hybrid medical care model, which consists of alternating face-to-face medical visits and video medical consultations, is not inferior, in terms of the Patient Reported Outcomes measures (PROMs), to the face-to-face medical care model, among rheumatoid arthritis (RA) outpatients. We also aim to investigate if adherence to RA-related treatment (considered a surrogate of patient´s education) might be improved when patients are re-integrated to the health care system, irrespective of the health care model.\n\nIn Mexico, COVID-19 pandemic still uncontrolled. Our Institution provides health care to 1500 RA patients/year and up to August 2020, it is estimated that 500 RA patients might be affected, which is our target audience. Reinstalling institutional health care provision is challenging.\n\nThis a non-inferiority, cross-over study, with 2 intervention arms. Patients will be randomized to 1. Six months of usual medical care model, followed by 4 months of a control period, and 6 months of hybrid medical care model, or 2. Six months of hybrid medical care model, followed by 4 months of a control period, and 6 months of usual medical care model.\n\nThe following PROMs will be assessed at specific time points: disease activity/disease severity (RAPID-3), disability (HAQ-DI), quality of life (WHOQOL-BREF), patient satisfaction with the medical care model (questionnaire locally developed), patient´s adherence to medical care (missed scheduled visits) and patient´s adherence to RA-related treatment (the Compliance-Questionnaire).', 'detailedDescription': "This a non-inferiority and cross-over study, with a planned follow-up of 16 months, with 2 intervention arms:\n\nIntervention 1: Patients assigned to 6 months of usual medical care model, followed by 4 months control period, and finally 6 months of hybrid medical care model.\n\nIntervention 2: Patients assigned to 6 months of hybrid medical care model, followed by 4 months control period and finally 6 months of usual medical care model.\n\nSpecific objectives are as follows:\n\nPrimary objectives\n\n1. To compare the mean disease activity of RA patients (as measured per RAPID-3), after 6 months since study entry, between patients assigned to intervention 1 and patients assigned to intervention 2.\n2. To compare the RA patient´s quality of life (as measured per WHOQOL-BREF) and RA patient's disability (as measured per HAQ-DI) after 6 months since study entry, between patients assigned to intervention 1 and patients assigned to intervention 2.\n\nSecondary objectives:\n\n1. At the end of the complete follow-up period, for each patient, to compare the cumulative RA disease activity during the 6 months period where patients received usual medical care model, with the cumulative disease activity during the 6 months period where patients received hybrid medical care model.\n2. At the end of the complete follow-up period, for each patient, to compare patient´s satisfaction with usual medical care model and patient´s satisfaction to hybrid medical care model.\n3. At the end of the complete follow-up period, for each patient, to compare patient´s adherence to the usual medical care model with patient´s adherence to hybrid medical care model."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with RA diagnosis according to their primary rheumatologist\n* With at least six months of follow-up (up to March 2020) at the outpatient clinic\n* Who agree to participate\n\nExclusion Criteria:\n\n* Patients lost to follow-up from the outpatient clinic before March 2020\n* Patients with no access to a mobile device during their study participation\n* Patients with severe cognitive, visual and hearing impairment\n* Patients on palliative care because of comorbid condition'}, 'identificationModule': {'nctId': 'NCT04558905', 'briefTitle': 'Impact of a Hybrid Medical Care Model in the Rheumatoid Arthritis Patient-reported-outcomes Measures', 'organization': {'class': 'OTHER', 'fullName': 'National Institute of Medical Sciences and Nutrition, Salvador Zubiran'}, 'officialTitle': 'Impact of a Hybrid Medical Care Model (Face-to-face Medical Visits Alternating With Video Medical Consultations) in the Rheumatoid Arthritis Patient-reported-outcomes Measures: A Non-inferiority Study', 'orgStudyIdInfo': {'id': 'IRE-3438 20221'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Medical Care Model', 'description': 'All the patients will receive face-to-face medical visits', 'interventionNames': ['Other: Face-to-face medical visits']}, {'type': 'EXPERIMENTAL', 'label': 'Hybrid Medical Care Model', 'description': 'The patients will receive alternating face-to-face medical visits and video medical consultations', 'interventionNames': ['Other: Alternating face-to-face medical visits and video medical consultations']}], 'interventions': [{'name': 'Face-to-face medical visits', 'type': 'OTHER', 'description': 'Face-to-face medical visits', 'armGroupLabels': ['Usual Medical Care Model']}, {'name': 'Alternating face-to-face medical visits and video medical consultations', 'type': 'OTHER', 'description': 'Alternating face-to-face medical visits and video medical consultations', 'armGroupLabels': ['Hybrid Medical Care Model']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14080', 'city': 'Mexico City', 'state': 'Tlalpan', 'country': 'Mexico', 'facility': 'Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Virginia Pascual-Ramos, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Medical Sciences and Nutrition, Salvador Zubiran', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Rheumatologist', 'investigatorFullName': 'Virginia Pascual Ramos', 'investigatorAffiliation': 'National Institute of Medical Sciences and Nutrition, Salvador Zubiran'}}}}