Viewing Study NCT02628327


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Study NCT ID: NCT02628327
Status: COMPLETED
Last Update Posted: 2016-11-10
First Post: 2015-08-06
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Factors Influencing Patient Satisfaction in a Glaucoma Population
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-08', 'studyFirstSubmitDate': '2015-08-06', 'studyFirstSubmitQcDate': '2015-12-08', 'lastUpdatePostDateStruct': {'date': '2016-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life assessment', 'timeFrame': '6 months', 'description': 'Correlate demographic factors to vision related quality of life, eye disease and treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glaucoma care', 'quality of life', 'patient satisfaction'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': "1. To administer a questionnaire to patients seen by Wills Eye Glaucoma Department physicians at Wills Eye Hospital assessing satisfaction with their office visit, vision related quality of life, and related issues.\n2. To collect and de-identify information from each participant's medical chart related to their care including information pertaining to demographics, disease severity, and prior and current treatment\n3. To assess the correlations between demographic factors, vision related quality of life, eye disease, and treatments with patient satisfaction survey responses.", 'detailedDescription': "This prospective study aims to recruit up to 250 patients being seen by glaucoma specialists at Wills Eye Hospital. Informed consent will be obtained prior to the office visit. Patients will complete a satisfaction survey with a few additional questions about themselves and their vision. Electronic health records (EHR) will be used to collect race, gender, age, glaucoma diagnosis, current and prior treatments, timing of appointment and care, visual acuity and field data, and distance to patient's home. Additional information captured will include weather, time of day, day of week.\n\nIn addition to completing the questionnaire subjects will be asked to provide their name and date of birth. Trained research staff members will use this information to find patients on the EHR system. A research assistant will later abstract information from the patient's EHR. This information will be tagged to the survey by a unique identifier, but all patient identity related information will be removed, including name and date of birth. Patients will be made aware that research staff will be retrieving their protected health information (PHI) for the purpose of this study through the consent form."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Glaucoma or glaucoma suspect', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge \\> 18 years; patients who have a scheduled appointment at with a glaucoma specialist at Wills Eye Hospital; diagnosis of glaucoma or glaucoma suspect\n\nExclusion Criteria:\n\nChildren under the age of 18; inability to give informed consent; patients who are physically and/or mentally incapable of filling out a paper survey; patients who are not literate in English.'}, 'identificationModule': {'nctId': 'NCT02628327', 'acronym': 'FIPSS', 'briefTitle': 'Factors Influencing Patient Satisfaction in a Glaucoma Population', 'organization': {'class': 'OTHER', 'fullName': 'Wills Eye'}, 'officialTitle': 'Factors Influencing Patient Satisfaction in a Glaucoma Population', 'orgStudyIdInfo': {'id': '15-496E'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Glaucoma subjects', 'description': 'Survey given to all glaucoma subjects agreening to study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Wills Eye Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Jonathan Myers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wills Eye Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'A manuscript has been submitted to the Journal of Medical Quality'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wills Eye', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Jonathon Myers', 'investigatorAffiliation': 'Wills Eye'}}}}