Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT05554705
Status:
TERMINATED
Last Update Posted:
2023-08-04
First Post:
2022-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lifestyle Intervention for Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D040242', 'term': 'Risk Reduction Behavior'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'whyStopped': 'Lost necessary staff support', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-01-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-02', 'studyFirstSubmitDate': '2022-09-17', 'studyFirstSubmitQcDate': '2022-09-22', 'lastUpdatePostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HAQ-2 score', 'timeFrame': 'Up to 24 months', 'description': 'The HAQ-II is a validated and reliable tool used frequently by rheumatologists evaluating patients with RA (Wolfe et al, 2004). It is an indicator of quality of life as well as functional status. It is also a predictor of premature mortality.'}, {'measure': 'Change in serum C-Reactive Protein', 'timeFrame': 'Up to 24 months', 'description': 'CRP is a reliable marker of acute and chronic inflammation (Sproston and Ashworth, 2018).'}], 'secondaryOutcomes': [{'measure': 'Change in dosage of RA-related medications', 'timeFrame': 'Up to 24 months', 'description': 'Dosage of Medications Taken Specifically for Rheumatoid Arthritis'}, {'measure': 'Change in the number of medications required to treat RA', 'timeFrame': 'Up to 24 months', 'description': 'Number of Medications Taken Specifically for Rheumatoid Arthritis'}, {'measure': 'Change in RA-related costs for the study participant', 'timeFrame': 'Up to 24 months', 'description': 'Out of Pocket costs related to Rheumatoid Arthritis Care'}, {'measure': 'Change in RA-related costs to the insurer', 'timeFrame': 'Up to 24 months', 'description': 'Costs for care of Rheumatoid Arthritis paid by insurer'}, {'measure': 'Change in serum LDL cholesterol', 'timeFrame': 'Up to 24 months', 'description': 'Elevated Low Density Lipoprotein is strongly associated with heart disease'}, {'measure': 'Change in serum total cholesterol', 'timeFrame': 'Up to 24 months', 'description': 'Elevated total cholesterol is associated with heart disease'}, {'measure': 'Change in serum HbA1c', 'timeFrame': 'Up to 24 months', 'description': 'Hemoglobin HbA1c is used to assess glucose control in diabetics'}, {'measure': 'Change in blood pressure', 'timeFrame': 'Up to 24 months', 'description': 'Blood pressure change'}, {'measure': 'Change in BMI', 'timeFrame': 'Up to 24 months', 'description': 'Body Mass Index change'}, {'measure': 'Change in weight', 'timeFrame': 'Up to 24 months', 'description': 'Weight change'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lifestyle Risk Reduction', 'Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to assess whether adding a multifaceted lifestyle intervention to the standard best practice of care can be more effective than standard best practices alone for treating Rheumatoid Arthritis.', 'detailedDescription': 'The main purpose of this study is to assess whether adding a multifaceted lifestyle intervention to the standard best practice of care can be more effective than standard best practices alone for treating Rheumatoid Arthritis. If a lifestyle intervention is effective, we expect to see improvement in functional status and decreased health care costs to the study participant and the insurer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. BCBSVT members who also carry the prescription benefit with BCBSVT (due to the need for tracking prescription costs).\n2. BCBSVT membership for minimum of 12 months prior to start of study (due to the need for tracking prescription costs before and after intervention).\n3. Age 18 or older\n4. Medical diagnosis of RA\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Currently taking warfarin (since fluctuating amounts of green leafy vegetable intake can adversely affect INR levels and because we will be asking participants to increase the amount of green leafy vegetables they consume)\n3. Malignancy currently undergoing treatment (with further planned treatment at the time of enrollment) since patients undergoing cancer treatment often need to stop RA medications in order to improve immune function, and thus could be a confounder.\n4. Food allergy (including reactions such as hives, wheezing, difficulty breathing, fainting, or anaphylaxis)'}, 'identificationModule': {'nctId': 'NCT05554705', 'briefTitle': 'Lifestyle Intervention for Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Blue Cross Blue Shield of Vermont'}, 'officialTitle': 'A Lifestyle Intervention for Rheumatoid Arthritis: Effect of an Intensive Therapeutic Lifestyle Change Program on Inflammatory Markers and Clinical Outcomes', 'orgStudyIdInfo': {'id': '22-08-629-1275'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental', 'description': 'standard of care + lifestyle intervention', 'interventionNames': ['Behavioral: Intensive Lifestyle intervention']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'no intervention (control group)'}], 'interventions': [{'name': 'Intensive Lifestyle intervention', 'type': 'BEHAVIORAL', 'description': '12 week therapeutic lifestyle change program', 'armGroupLabels': ['experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05602', 'city': 'Berlin Corners', 'state': 'Vermont', 'country': 'United States', 'facility': 'Blue Cross Blue Shield of Vermont', 'geoPoint': {'lat': 44.21006, 'lon': -72.57594}}], 'overallOfficials': [{'name': 'Keri LeCompte, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Blue Cross Blue Shield of Vermont'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Blue Cross Blue Shield of Vermont', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}