Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
Study NCT ID:
NCT05484258
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2022-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Loneliness and Health Outcomes in the High Need Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-15', 'size': 46879, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-07-29T11:28', 'hasProtocol': True}, {'date': '2022-07-15', 'size': 260212, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-07-29T11:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-05', 'studyFirstSubmitDate': '2022-07-27', 'studyFirstSubmitQcDate': '2022-07-29', 'lastUpdatePostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Loneliness from Baseline at 0 and at 3, 6 and 9 months.', 'timeFrame': '0, 3, 6, and 9 months', 'description': 'Using the Validated De Jong Giervald Loneliness Scale, scored from 0 (not lonely) to 11 (severely lonely),'}], 'secondaryOutcomes': [{'measure': 'Change in the number of ED visits, Inpatient, Observations', 'timeFrame': '0, 3, 6 and 9 months', 'description': 'ED Visits and Hospital Utilization (Inpatient, Observation Admissions)'}, {'measure': 'Change in Depression from Baseline (0), and at 3, 6, and 9 months', 'timeFrame': '0, 3,6, and 9 months', 'description': 'Will be using PHQ 9 to evaluate depression in the population, 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression'}, {'measure': 'Change in Active alcohol use disorders (including alcohol abuse or dependence) from Baseline (0), and at 3, 6, and 9 months', 'timeFrame': '0,3,6, and 9 months', 'description': "he AUDIT-C has 3 questions and is scored on a scale of 0-12. Each AUDIT-C question has 5 answer choices valued from 0 points to 4 points. In men, a score of 4 or more is considered positive, optimal for identifying hazardous drinking or active alcohol use disorders. In women, a score of 3 or more is considered positive. Generally the higher the score, the more likely it is that a person's drinking is affecting his or her safety."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['high need population', 'shared medical visits', 'social determinants of health'], 'conditions': ['Anxiety', 'Loneliness', 'Depression', 'Alcohol Use Disorder', 'Utilization, Health Care']}, 'descriptionModule': {'briefSummary': 'The high need population are patients who have three or more chronic diseases and have a functional limitation in their ability to take care for themselves. Investigators aim to understand the effects of a support group intervention, with the use of group medical visits and understand longitudinal effects in emotional wellbeing and loneliness.', 'detailedDescription': 'The high need population with functional limitations are patients who have three or more chronic diseases and have a functional limitation in their ability to care for themselves (such as bathing or dressing) or perform routine daily tasks. Two-thirds of the population is female, and three-quarters of them are white non-Hispanic and half of the population were described as low income. The High Need Population with functional limitations also utilizes the emergency department at twice the rate of adults with multiple chronic diseases and more than three times more likely to be hospitalized than adults of other populations.\n\nLoneliness is seen as a significant independent risk factor for poor health behaviors, physical health problems and psychiatric conditions. Loneliness and isolation are becoming a more recognized entity that contributes to worsening depression.\n\nInvestigators aim to compare the of effects of a Social Worker and Physician/APP-led support group intervention on loneliness at 9 months, after up to 3 group visits.\n\nShared Medical Visits as a form of support Group increase clinician-patient contact time and provide patients with support and prevention of chronic conditions increasing patient empowerment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients who are enrolled into the VIC program. These are patients that are 18 years old and above, and have either\n\n* HCC Score 3.0 and above\n* HCC 2.0 - 3.0 and 2 or more unplanned admissions in last 12 months\n* HCC 0.24 - 0.35 + ESRD OR\n* Charlson Score \\>3, or LACE \\>30\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05484258', 'briefTitle': 'Loneliness and Health Outcomes in the High Need Population', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Loneliness and Health Outcomes in the High Need Population', 'orgStudyIdInfo': {'id': '220958'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'On baseline screen, would be screened for depression, alcohol use, and loneliness. Loneliness screen will be checked every 3 months.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group Medical VIsits', 'description': 'For this arm, patients will have three visits of a shared medical visit, wherein a physician/APP will partner with a social worker to give a discussion about topics relevant to the high need population, including managing multiple medications, managing stress, and also palliative care.', 'interventionNames': ['Behavioral: Shared Medical Visit']}], 'interventions': [{'name': 'Shared Medical Visit', 'type': 'BEHAVIORAL', 'description': 'Group visit wherein physician and Social Worker, would be discussing topics relevant to the population.', 'armGroupLabels': ['Group Medical VIsits']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'FRANCIS S BALUCAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'July 2023 available for 1 year', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director', 'investigatorFullName': 'Francis Balucan', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}