Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-01-02 @ 12:06 PM
Study NCT ID:
NCT03304535
Status:
COMPLETED
Last Update Posted:
2017-10-09
First Post:
2016-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Social Worker in an Eye-Care Service
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-03', 'studyFirstSubmitDate': '2016-02-22', 'studyFirstSubmitQcDate': '2017-10-03', 'lastUpdatePostDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in response to Patient Health Questionnaire 9', 'timeFrame': '6 months', 'description': 'Measures participant levels of depression based on questions related to depressive symptoms. The investigator will assess change in the number of participants with major, moderate, and minimal depressive symptoms.'}], 'secondaryOutcomes': [{'measure': 'Change in response to Distress thermometer', 'timeFrame': '6 months', 'description': 'Measures participant level of distress on a scale of 1 to 10 and asks additional questions regarding contributors to distress.'}, {'measure': 'Change in response to Modified Patient Activation Measure 13', 'timeFrame': '6 months', 'description': 'Measures participant self-capacity for and confidence regarding glaucoma management.'}, {'measure': 'Descriptive results of the Social Worker Baseline Assessment', 'timeFrame': '6 months', 'description': "Social worker will assess each participant's internal and external barriers to care, limitations, and strengths that may help them to manage their glaucoma."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glaucoma', 'Social Worker'], 'conditions': ['Glaucoma']}, 'referencesModule': {'references': [{'pmid': '26860278', 'type': 'BACKGROUND', 'citation': 'Fudemberg SJ, Amarasekera DC, Silverstein MH, Linder KM, Heffner P, Hark LA, Waisbourd M. Overcoming Barriers to Eye Care: Patient Response to a Medical Social Worker in a Glaucoma Service. J Community Health. 2016 Aug;41(4):845-9. doi: 10.1007/s10900-016-0162-1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to determine whether involvement with a social worker helps reduce distress, depression, and increase patient activation in participants over a 6 month intervention period. The study will also describe common barriers to care that participants face.', 'detailedDescription': "An appointment will be scheduled for participant to meet with a social worker. The appointment may happen on day of participant's scheduled clinic appointment or on another mutually decided upon date and time. Should participant choose to participate, this first visit will be Visit 1 for the study.\n\nVisit 1: Baseline\n\nInformed consent will be obtained demonstrating an interest in participating.\n\nA visit with the social worker will take place during Visit 1. This session will be held in a private office and allows participant time for discussion regarding any challenges, struggles and/or barriers they may be experiencing.\n\nThe following baseline questionnaires/surveys will be administered:\n\nModified Patient Activation Measure - measures participant confidence in taking care of their own health.\n\nDistress Thermometer - measures participant distress level during the past week.\n\nPatient Health Questionnaire -measures depression symptoms and severity if any.\n\nClinical information will be taken from participant's medical record. There may be follow-up questions related to data if information is unclear or incomplete.\n\nUpon completion of Visit 1, participant will receive a satisfaction survey to evaluate how participant satisfaction with social worker interaction.\n\nSocial Worker Interventions: After Visit 1 and before Visit 2\n\nThe social worker will develop an intervention for participant during Visit 1 appointment. As many calls or in person meetings participant requires will take place. There will be no limit and it will be determined by participant's needs.\n\nVisit 2: Follow-up After 6 Months\n\nUpon completion of participant's six month follow-up in the study, the following questionnaires/surveys will be administered:\n\nModified Patient Activation Measure - measures how confident participant is at taking care of their own health.\n\nDistress Thermometer - measures how much distress participant has been experiencing in the past week.\n\nPatient Health Questionnaire - measures if participant has symptoms of depression and the severity of those symptoms.\n\nSatisfaction Survey - measures how satisfied participant is with the social worker interaction."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with any type of Glaucoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients seen at Wills Eye Hospital in the Glaucoma Service\n* Glaucoma of any type, characterized by glaucomatous optic neuropathy and corresponding visual field (VF) defect\n* Referred to staff social worker for intervention\n* Ability to read, write, speak and understand English\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03304535', 'briefTitle': 'Social Worker in an Eye-Care Service', 'organization': {'class': 'OTHER', 'fullName': 'Wills Eye'}, 'officialTitle': 'The Impact of a Social Worker in a Glaucoma Eye-Care Service: A Prospective Study', 'orgStudyIdInfo': {'id': 'IRB#15-XXX'}}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Wills Eye Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Scott J Fudemberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wills Eye Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wills Eye', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Scott Fudemberg, MD', 'investigatorAffiliation': 'Wills Eye'}}}}