Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 10:32 AM
Study NCT ID:
NCT06859060
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-05
First Post:
2025-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Health and Wellness for People With Serious Mental Illness in Puerto Rico
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D057545', 'term': 'Social Stigma'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2029-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2025-02-27', 'studyFirstSubmitQcDate': '2025-02-27', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recipt of Preventive Primary Care', 'timeFrame': 'baseline,6 and 12 months follow up and 6 and 12 months post intervention', 'description': '29-item questionnaire developed by team members. It uses preventive primary care indicators from the US Preventive Service Task Force Guidelines extracted from medical records and examines the use of physical health services over the past 6-months.Indicators are grouped into six categories: physical examinations, screenings for women, screenings for men, laboratory tests, vaccinations, and education. An aggregate preventive primary score is calculated representing the proportion of services for which each participant was eligible depending on age and gender.'}], 'secondaryOutcomes': [{'measure': 'Hemoglobin A1c', 'timeFrame': 'baseline,6 and 12 months follow up and 6 and 12 months post intervention', 'description': 'The A1C test is a simple common blood test used to measure blood sugar levels over the past 3 months.'}, {'measure': 'Lipid Panel', 'timeFrame': 'baseline,6 and 12 months follow up and 6 and 12 months post intervention', 'description': 'The Lipid panel is a simple common blood test used to examine cardiovascular health by analyzing cholesterol in the blood. This test examines four types of lipids in the blood, namely: 1) Total cholesterol, 2 Low-density lipoprotein (LDL), 3) High-density lipoprotein (HDL), and 4) Triglycerides.'}, {'measure': 'Basic Metabolic Panel', 'timeFrame': 'baseline,6 and 12 months follow up and 6 and 12 months post intervention', 'description': 'It is a simple common blood group of tests used to examine different naturally occurring chemicals in the blood. The tests can give information heart, kidneys, and liver function. It includes Blood urine nitrogen (BUN), carbon dioxide (C02), Creatinine, Glucose, Serum chloride, Serum potassium, Serum sodium, and Serum Calcium.'}, {'measure': 'Smoking - Severity Dependence Scale', 'timeFrame': 'baseline,6 and 12 months follow up and 6 and 12 months post intervention', 'description': 'Five-item scale, used to assess severity of smoking.'}, {'measure': 'Physical Activity - International Physical Activity Questionnaire', 'timeFrame': 'baseline,6 and 12 months follow up and 6 and 12 months post intervention', 'description': 'This is a 7-item measure widely used to examine 4 types of physical activity: 1) vigorous, 2) moderate, 3) walking and 4) sitting.'}, {'measure': 'Health Literacy - Test of Functional Health Literacy for Adults', 'timeFrame': 'baseline,6 and 12 months follow up and 6 and 12 months post intervention', 'description': 'Questionnaire with 12 items measuring adult functional health literacy in the health care setting.'}, {'measure': 'Self-Stigma - Self-Stigma of Mental Illness Scale', 'timeFrame': 'baseline,6 and 12 months follow up and 6 and 12 months post intervention', 'description': "This 40-item measure examines self stigma's four dimensions (awareness, agreement, self-application and self esteem)."}, {'measure': 'Provider Stigma - The Mental Health Stigma Scale for Health Professionals', 'timeFrame': 'baseline,6 and 12 months follow up and 6 and 12 months post intervention', 'description': '12-item measure examining provider stigma dimensions (social distance, negative character attributions and self-sufficiency).'}, {'measure': 'Patient-Provider Relationship - Patient Assessment of Chronic Illness Care', 'timeFrame': 'baseline,6 and 12 months follow up and 6 and 12 months post intervention', 'description': "20-item scale used to assess participants' perspectives on the quality and patient-centeredness of chronic illness care received during the past 6 months from their primary care provider."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bridges', 'Stigma', 'Preventive Primary Care', 'Healthcare Managers', 'Wellness'], 'conditions': ['Chronic Disease', 'Serious Mental Illness']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effectiveness of a culturally tailored intervention, Bridges to Better Health and Wellness (BRIDGES), aimed at reducing chronic disease disparities among Puerto Ricans with serious mental illness (SMI). Participants receive monthly sessions with health care managers to address patient-provider stigma and care coordination.', 'detailedDescription': 'BRIDGES is a multi-level Healthcare Manager Intervention (HMI) that addresses both patient and provider barriers to healthcare. It includes culturally adapted modules to reduce stigma and promote chronic disease prevention. The study uses a hybrid type 1 effectiveness-implementation randomised controlled trial to test its impact on primary care service use, chronic disease outcomes and stigma reduction over 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nAdults receiving psychiatric or psychological services at the Wellness Center or the Mayaguez Medical Center - Primary Care Diagnosed with at least one serious mental illness SMI (e.g., schizophrenia, bipolar disorder, major depression, etc.) Have at least one risk factor or a diagnosis of a chronic health condition (e.g., diabetes, overweight, hypertension, etc.).\n\nBe willing to receive or continue preventive medical care with a primary care physician.\n\nExclusion criteria:\n\nHave started psychiatric or mental health services at least one month before Have been diagnosed with a general mental health condition (e.g., Depression or Anxiety).'}, 'identificationModule': {'nctId': 'NCT06859060', 'acronym': 'BRIDGES', 'briefTitle': 'Improving Health and Wellness for People With Serious Mental Illness in Puerto Rico', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ponce Medical School Foundation, Inc.'}, 'officialTitle': 'Testing Bridges to Better Health and Wellness for People Living With Serious Mental Illness in Puerto Rico', 'orgStudyIdInfo': {'id': '2308159485'}, 'secondaryIdInfos': [{'id': '2U54MD007579-39', 'link': 'https://reporter.nih.gov/quickSearch/2U54MD007579-39', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BRIDGES Intervention', 'description': 'Participants randomized to the experimental condition will receive the BRIDGES Healthcare Manager Intervention.', 'interventionNames': ['Behavioral: BRIDGES Healthcare Manager Intervention']}, {'type': 'OTHER', 'label': 'Enhanced Treatment as Usual (ETAU)', 'description': 'Participants randomized to the control condition will receive standard psychiatric care with an informational brochure on accessing primary care providers.', 'interventionNames': ['Other: Enhanced Treatment as Usual (ETAU)']}], 'interventions': [{'name': 'BRIDGES Healthcare Manager Intervention', 'type': 'BEHAVIORAL', 'description': 'A culturally adapted, multilevel intervention consisting of monthly 60-minute sessions over a 12-month period. Sessions will be conducted by graduate clinical psychology students acting as healthcare managers. The intervention focuses on care coordination, patient activation, and reducing provider stigma to improve access to preventive primary care services.', 'armGroupLabels': ['BRIDGES Intervention']}, {'name': 'Enhanced Treatment as Usual (ETAU)', 'type': 'OTHER', 'description': 'Participants will continue to receive standard psychiatric care, including routine visits with their mental health providers at the designated clinical sites. They will also receive a booklet with information on how best to link with primary care providers. This ensures that participants are aware of available resources and basic health care recommendations, but does not include any active follow-up or intervention components.', 'armGroupLabels': ['Enhanced Treatment as Usual (ETAU)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00681', 'city': 'Mayagüez', 'state': 'Puerto Rico', 'country': 'Puerto Rico', 'contacts': [{'name': 'Nelmit Tollinchi, PhD', 'role': 'CONTACT', 'email': 'bridgespr@psm.edu', 'phone': '939-905-0420'}, {'name': 'Eliut Rivera-Segarra, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayagüez Medical Center Primary Care Psychology Clinic', 'geoPoint': {'lat': 18.20107, 'lon': -67.13962}}, {'zip': '00716', 'city': 'Ponce', 'state': 'Puerto Rico', 'country': 'Puerto Rico', 'contacts': [{'name': 'Nelmit Tollinchi, PhD', 'role': 'CONTACT', 'email': 'bridgespr@psm.edu', 'phone': '939-905-0420'}, {'name': 'Eliut Rivera-Segarra, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'PHSU Wellness Center', 'geoPoint': {'lat': 18.01031, 'lon': -66.62398}}], 'centralContacts': [{'name': 'Eliut Rivera-Segarra, PhD', 'role': 'CONTACT', 'email': 'elrivera@psm.edu', 'phone': '787-840-2575'}, {'name': 'Nelmit Tollinchi, PhD', 'role': 'CONTACT', 'email': 'bridgespr@psm.edu', 'phone': '939-905-0420'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ponce Medical School Foundation, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}