Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-31 @ 9:11 PM
Study NCT ID:
NCT03194828
Status:
TERMINATED
Last Update Posted:
2018-11-07
First Post:
2017-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-time Glaucoma Medication Adherence
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Lack of sufficient recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2018-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-05', 'studyFirstSubmitDate': '2017-05-09', 'studyFirstSubmitQcDate': '2017-06-19', 'lastUpdatePostDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence', 'timeFrame': 'From study baseline through the 3 months of the intervention', 'description': 'Changes and differences in adherence to glaucoma medication between groups'}, {'measure': 'Adherence follow-up', 'timeFrame': 'From study endpoint through the subsequent 3 months', 'description': 'Changes and differences in adherence to glaucoma medication between groups after the intervention'}], 'secondaryOutcomes': [{'measure': 'Medication self-efficacy using the 10-item Glaucoma Medication Adherence Self-Efficacy Scale', 'timeFrame': 'Change from baseline over the 3-month intervention', 'description': 'Differences in self-reported medication-related self-efficacy between groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adherence', 'Mobile health', 'Real-time data'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effectiveness of real-time data collected on patients taking topical medication to treat glaucoma. Patients will be randomized to two groups, the first of which will only use the study device to take their medication, while the second will use the study device and receive on-demand reminder messages, when necessary.', 'detailedDescription': 'Adherence to topical medications to treat glaucoma remains sub optimal; however, our understanding of this behavior remains limited due to biased measures of medication use. The Kali Drop device is a potential improvement in our ability to capture medication use in patients using dropper bottles by precisely capturing the amount dispensed in real-time. Moreover, such technology creates data that can be leveraged into driving behavior change using connected mobile technology in order to improve adherence and, ultimately, health outcomes. While evidence suggests that reminders may improve adherence to glaucoma medications, the power of doing so using real-time data has yet to be explored. This study will compare simple monitoring of patients to those who are being monitored and who receive reminder messages when the system determines one is necessary due to a missed dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age and older\n* Glaucoma diagnosis\n* Prescription for a prostaglandin indicated for glaucoma\n* Nonadherent (MPR\\<80%) in the last 3 months according to pharmacy records\n* Owns and operates a mobile phone and willing to receive periodic reminder messages\n\nExclusion Criteria:\n\n* Existing chronic eye condition in addition to glaucoma\n* Scheduled for eye surgery in the next 90 days\n* Prescription for a medication that will not fit in the device\n* Non-English speaking'}, 'identificationModule': {'nctId': 'NCT03194828', 'briefTitle': 'Real-time Glaucoma Medication Adherence', 'organization': {'class': 'OTHER', 'fullName': 'University of Tennessee'}, 'officialTitle': 'Leveraging Real-Time Medication Use Monitoring to Improve Adherence in Adults With Glaucoma', 'orgStudyIdInfo': {'id': '17-05074-XP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Monitoring only', 'description': 'Patients in this arm will be given a real-time medication use monitor to use in dispensing their topical glaucoma medication for 3 months', 'interventionNames': ['Behavioral: Medication monitoring only']}, {'type': 'EXPERIMENTAL', 'label': 'Monitoring and reminder', 'description': "Patients in this arm will be given a real-time medication use monitor to use in dispensing their topical glaucoma medication for 3 months and will receive an automated reminder (text or voice) when a missed dose is determined by the device's system", 'interventionNames': ['Behavioral: Medication reminder']}], 'interventions': [{'name': 'Medication reminder', 'type': 'BEHAVIORAL', 'description': 'Using the real-time data capture of the electronic device, an automated voice call or text message will be sent to active arm participants only when a missed dose is determined', 'armGroupLabels': ['Monitoring and reminder']}, {'name': 'Medication monitoring only', 'type': 'BEHAVIORAL', 'description': 'Patients will use an electronic medication monitoring device to record their actual medication use', 'armGroupLabels': ['Monitoring only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30906', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': "Barney's Pharmacy", 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30907', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': "Barney's Pharmacy", 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30813', 'city': 'Grovetown', 'state': 'Georgia', 'country': 'United States', 'facility': "Barney's Pharmacy", 'geoPoint': {'lat': 33.45042, 'lon': -82.19818}}, {'zip': '30434', 'city': 'Louisville', 'state': 'Georgia', 'country': 'United States', 'facility': "Barney's Pharmacy", 'geoPoint': {'lat': 33.00154, 'lon': -82.41124}}, {'zip': '74631', 'city': 'Blackwell', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Hutton Pharmacy', 'geoPoint': {'lat': 36.80448, 'lon': -97.28282}}, {'zip': '73013', 'city': 'Edmond', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Creative Care Pharmacy', 'geoPoint': {'lat': 35.65283, 'lon': -97.4781}}, {'zip': '73064', 'city': 'Mustang', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Mustang Drug', 'geoPoint': {'lat': 35.38423, 'lon': -97.72449}}, {'zip': '37210', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee College of Pharmacy', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Justin Gatwood, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tennessee'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tennessee', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kali Care', 'class': 'UNKNOWN'}, {'name': "Barney's Pharmacy", 'class': 'UNKNOWN'}, {'name': 'Creative Care Pharmacy', 'class': 'UNKNOWN'}, {'name': 'Hutton Pharmacy', 'class': 'UNKNOWN'}, {'name': 'Mustang Drug', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}