Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2026-01-04 @ 3:37 AM
Study NCT ID:
NCT03052257
Status:
COMPLETED
Last Update Posted:
2024-05-02
First Post:
2017-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improve Glaucoma Medication Adherence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Kelly.Muir@va.gov', 'phone': '919-286-0411', 'title': 'Dr. Kelly Muir', 'phoneExt': '174035', 'organization': 'Durham VA Medical Center, Durham, NC'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'Participants were randomized educational intervention developed to improve glaucoma medication adherence. This included a discussion of glaucoma and the potential for blindness, facilitated by the glaucoma educator using a 3-dimensional model eye and photographic representation of glaucomatous vision loss; One-one-one demonstration of eye drop instillation techniques, provision of a mnemonic aid which alerts the participant to missed doses; Review of the participant manual: An illustrated brochure on glaucoma and eye drop instillation, an individualized schedule for dosing of glaucoma medications. Individualized suggestions for improving adherence based on the subject\'s responses to the (SASES). Participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle was opened and a reminder through AdhereTech was activated.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 1, 'seriousNumAtRisk': 100, 'deathsNumAffected': 4, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Control', 'description': 'Participants randomized to receive general eye health educational session, the control information session included review of a PowerPoint presentation on general eye health, including but not specific to glaucoma. All participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle is opened.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'deathsNumAffected': 2, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Prescribed Glaucoma Medication Doses Taken on Schedule', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants were randomized educational intervention developed to improve glaucoma medication adherence. This included a discussion of glaucoma and the potential for blindness, facilitated by the glaucoma educator using a 3-dimensional model eye and photographic representation of glaucomatous vision loss; One-one-one demonstration of eye drop instillation techniques, provision of a mnemonic aid which alerts the participant to missed doses; Review of the participant manual: An illustrated brochure on glaucoma and eye drop instillation, an individualized schedule for dosing of glaucoma medications. Individualized suggestions for improving adherence based on the subject\'s responses to the (SASES). Participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle was opened and a reminder through AdhereTech was activated.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants randomized to receive general eye health educational session, the control information session included review of a PowerPoint presentation on general eye health, including but not specific to glaucoma. All participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle is opened.'}], 'classes': [{'categories': [{'measurements': [{'value': '.84', 'groupId': 'OG000', 'lowerLimit': '0.78', 'upperLimit': '0.90'}, {'value': '0.62', 'groupId': 'OG001', 'lowerLimit': '0.56', 'upperLimit': '0.67'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '0.15', 'ciUpperLimit': '0.30', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.04', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization to 6 Months', 'description': 'Will veterans randomized to the intervention have a greater proportion of prescribed glaucoma medication doses taken as measured by the electronic medication monitor in the 6 months following the intervention compared to Veterans randomized to the control arm? The electronic bottle records the date and time that the bottle is opened. For participants in the intervention arm only, a reminder through the electronic bottle will be activated. The outcome measure is the proportion of prescribed doses taken with a minimum of Zero and a maximum of One; where higher scores indicate more adherence.', 'unitOfMeasure': 'proportion of doses', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '95 Intervention: Of the 100 randomized to Intervention - 2 subjects withdrew after randomization and 3 subjects excluded for not having at least 25 weeks of adherence data 97 Control: Of the 100 randomized to Control - 1 subject excluded by PI for not taking medication and 2 subjects excluded for not having at least 25 weeks of adherence data'}, {'type': 'SECONDARY', 'title': 'VA Medical Resource Use and Costs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants were randomized educational intervention developed to improve glaucoma medication adherence. This included a discussion of glaucoma and the potential for blindness, facilitated by the glaucoma educator using a 3-dimensional model eye and photographic representation of glaucomatous vision loss; One-one-one demonstration of eye drop instillation techniques, provision of a mnemonic aid which alerts the participant to missed doses; Review of the participant manual: An illustrated brochure on glaucoma and eye drop instillation, an individualized schedule for dosing of glaucoma medications. Individualized suggestions for improving adherence based on the subject\'s responses to the (SASES). Participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle was opened and a reminder through AdhereTech was activated.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants randomized to receive general eye health educational session, the control information session included review of a PowerPoint presentation on general eye health, including but not specific to glaucoma. All participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle is opened.'}], 'classes': [{'categories': [{'measurements': [{'value': '10947', 'spread': '19341', 'groupId': 'OG000'}, {'value': '12939', 'spread': '25199', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The investigators will investigate the overall budget impacts to the VA healthcare system. The main intervention costs are labor inputs, consisting of the one-time fixed labor cost of training and the variable labor cost of conducting the adherence intervention. The VA healthcare system also incurs costs, such as administration, utilities, and custodial services that cannot be directly attributed to a given health care service but nonetheless should be included in the cost analysis.', 'unitOfMeasure': 'USD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '100 Intervention 100 Control'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Newly Prescribed Glaucoma Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants were randomized educational intervention developed to improve glaucoma medication adherence. This included a discussion of glaucoma and the potential for blindness, facilitated by the glaucoma educator using a 3-dimensional model eye and photographic representation of glaucomatous vision loss; One-one-one demonstration of eye drop instillation techniques, provision of a mnemonic aid which alerts the participant to missed doses; Review of the participant manual: An illustrated brochure on glaucoma and eye drop instillation, an individualized schedule for dosing of glaucoma medications. Individualized suggestions for improving adherence based on the subject\'s responses to the (SASES). Participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle was opened and a reminder through AdhereTech was activated.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants randomized to receive general eye health educational session, the control information session included review of a PowerPoint presentation on general eye health, including but not specific to glaucoma. All participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle is opened.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Months', 'description': 'Will the proportion of Veterans in the intervention arm that are prescribed more intensive glaucoma therapy be less than the proportion of Veterans in the control arm who are prescribed more intensive glaucoma therapy in the 12 months following the intervention? Baseline data collection will include cataloging the current glaucoma medication regimen prescribed to the participant. Chart abstractions will be performed at 12 months following the baseline visit and intensification of glaucoma therapy will be defined as either 1) the addition of another glaucoma medication to the baseline regimen, 2) recommendation for glaucoma laser treatment, or 3) recommendation for glaucoma surgery in the 12 months following the baseline visit .', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '200 randomized Veterans who are patients of the Durham VA Eye Clinic with medically-treated glaucoma.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Total Cost at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants were randomized educational intervention developed to improve glaucoma medication adherence. This included a discussion of glaucoma and the potential for blindness, facilitated by the glaucoma educator using a 3-dimensional model eye and photographic representation of glaucomatous vision loss; One-one-one demonstration of eye drop instillation techniques, provision of a mnemonic aid which alerts the participant to missed doses; Review of the participant manual: An illustrated brochure on glaucoma and eye drop instillation, an individualized schedule for dosing of glaucoma medications. Individualized suggestions for improving adherence based on the subject\'s responses to the (SASES). Participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle was opened and a reminder through AdhereTech was activated.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants randomized to receive general eye health educational session, the control information session included review of a PowerPoint presentation on general eye health, including but not specific to glaucoma. All participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle is opened.'}], 'classes': [{'categories': [{'measurements': [{'value': '1,149,600', 'groupId': 'OG000'}, {'value': '1,298,700', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'The proportion of participants attaining equal or \\>80% adherence as measured by electronic monitor, total intervention and medical resource costs, and incremental cost effectiveness ratios comparing intervention to control at 6 months.', 'unitOfMeasure': 'USD', 'reportingStatus': 'POSTED', 'populationDescription': '100 Intervention (hypothetical cohort) 100 Control (hypothetical cohort)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'VA Healthcare Workflow Effectiveness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants were randomized educational intervention developed to improve glaucoma medication adherence. This included a discussion of glaucoma and the potential for blindness, facilitated by the glaucoma educator using a 3-dimensional model eye and photographic representation of glaucomatous vision loss; One-one-one demonstration of eye drop instillation techniques, provision of a mnemonic aid which alerts the participant to missed doses; Review of the participant manual: An illustrated brochure on glaucoma and eye drop instillation, an individualized schedule for dosing of glaucoma medications. Individualized suggestions for improving adherence based on the subject\'s responses to the (SASES). Participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle was opened and a reminder through AdhereTech was activated.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants randomized to receive general eye health educational session, the control information session included review of a PowerPoint presentation on general eye health, including but not specific to glaucoma. All participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle is opened.'}], 'timeFrame': '12 months', 'description': 'The investigators will investigate the overall workload impacts to the VA healthcare system. Cost estimates and labor time data collected will be combined with glaucoma prevalence rates among Veterans to estimate overall workload impacts to the VA healthcare system.', 'reportingStatus': 'POSTED', 'populationDescription': 'Workflow changed significantly over the course of the study such that this outcome became not feasible to assess. Over the time that participants were enrolled, we had multiple staff and doctor changes, not to mention the pandemic.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cost-effectiveness Compared to Usual Care for Cost Per Blindness Averted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants were randomized educational intervention developed to improve glaucoma medication adherence. This included a discussion of glaucoma and the potential for blindness, facilitated by the glaucoma educator using a 3-dimensional model eye and photographic representation of glaucomatous vision loss; One-one-one demonstration of eye drop instillation techniques, provision of a mnemonic aid which alerts the participant to missed doses; Review of the participant manual: An illustrated brochure on glaucoma and eye drop instillation, an individualized schedule for dosing of glaucoma medications. Individualized suggestions for improving adherence based on the subject\'s responses to the (SASES). Participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle was opened and a reminder through AdhereTech was activated.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants randomized to receive general eye health educational session, the control information session included review of a PowerPoint presentation on general eye health, including but not specific to glaucoma. All participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle is opened.'}], 'timeFrame': '12 months', 'description': 'Will the intervention be cost-effectiveness compared to usual care for cost per blindness averted', 'reportingStatus': 'POSTED', 'populationDescription': 'While the long-term goal of this research program is to reduce glaucoma-related blindness in Veterans; in the course of the study period no participants went blind. We were unable to calculate this hypothesized outcome.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Within-Trial Cost-Effectiveness of Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants will be randomized to receive either a general eye health educational session (control arm) or an educational intervention developed to improve glaucoma medication adherence (intervention arm). All participants will be provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle records the date and time that the bottle is opened.\n\nEducational - glaucoma: Discussion of glaucoma and the potential for blindness, facilitated by the glaucoma educator using a 3-dimensional model eye and photographic representation of glaucomatous vision loss; One-one-one demonstration of eye drop instillation techniques, Provision of a mnemonic aid which alerts the participant to missed doses; Review of the participant manual: An illustrated brochure on glaucoma and eye drop instillation. An individualized schedule for dosing of glaucoma medications. Individualized suggestions for improving adherence based on the subject\'s responses to the (SASES).\n\nDose monitoring and reminder: Participants will be provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle records the date and time that the bottle is opened. For participants in the intervention arm only, a reminder through AdhereTech will be activated.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants will be randomized to receive either a general eye health educational session (control arm) or an educational intervention developed to improve glaucoma medication adherence (intervention arm). All participants will be provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle records the date and time that the bottle is opened.\n\nEducational - general: The control information session will include review of a Powerpoint presentation on general eye health, including but not specific to glaucoma.\n\nDose monitoring: Participants will be provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle records the date and time that the bottle is opened.'}], 'classes': [{'categories': [{'measurements': [{'value': '1,149,600', 'groupId': 'OG000'}, {'value': '1,298,700', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Will the intervention be cost-effectiveness compared to usual care? Total cost was calculated by adding the mean medical resource cost per patient to the cost of the intervention ($549) or the control ($48), then multiplying the total by the number of patients per group (100)', 'unitOfMeasure': 'USD', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'VA Workflow Effectiveness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants were randomized educational intervention developed to improve glaucoma medication adherence. This included a discussion of glaucoma and the potential for blindness, facilitated by the glaucoma educator using a 3-dimensional model eye and photographic representation of glaucomatous vision loss; One-one-one demonstration of eye drop instillation techniques, provision of a mnemonic aid which alerts the participant to missed doses; Review of the participant manual: An illustrated brochure on glaucoma and eye drop instillation, an individualized schedule for dosing of glaucoma medications. Individualized suggestions for improving adherence based on the subject\'s responses to the (SASES). Participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle was opened and a reminder through AdhereTech was activated.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants randomized to receive general eye health educational session, the control information session included review of a PowerPoint presentation on general eye health, including but not specific to glaucoma. All participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle is opened.'}], 'timeFrame': '12 months', 'description': 'The investigators will investigate the overall workload impacts to the VA healthcare system.', 'reportingStatus': 'POSTED', 'populationDescription': 'Workflow changed significantly over the course of the study such that this outcome became not feasible to assess. Over the time that participants were enrolled, we had multiple staff and doctor changes, not to mention the pandemic.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'Participants were randomized educational intervention developed to improve glaucoma medication adherence. This included a discussion of glaucoma and the potential for blindness, facilitated by the glaucoma educator using a 3-dimensional model eye and photographic representation of glaucomatous vision loss; One-one-one demonstration of eye drop instillation techniques, provision of a mnemonic aid which alerts the participant to missed doses; Review of the participant manual: An illustrated brochure on glaucoma and eye drop instillation, an individualized schedule for dosing of glaucoma medications. Individualized suggestions for improving adherence based on the subject\'s responses to the (SASES). Participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle was opened and a reminder through AdhereTech was activated.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Participants randomized to receive general eye health educational session, the control information session included review of a PowerPoint presentation on general eye health, including but not specific to glaucoma. All participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle is opened.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '97'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Participants were randomized educational intervention developed to improve glaucoma medication adherence. This included a discussion of glaucoma and the potential for blindness, facilitated by the glaucoma educator using a 3-dimensional model eye and photographic representation of glaucomatous vision loss; One-one-one demonstration of eye drop instillation techniques, provision of a mnemonic aid which alerts the participant to missed doses; Review of the participant manual: An illustrated brochure on glaucoma and eye drop instillation, an individualized schedule for dosing of glaucoma medications. Individualized suggestions for improving adherence based on the subject\'s responses to the (SASES). Participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle was opened and a reminder through AdhereTech was activated.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Participants randomized to receive general eye health educational session, the control information session included review of a PowerPoint presentation on general eye health, including but not specific to glaucoma. All participants were provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle recorded the date and time that the bottle is opened.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.9', 'spread': '8.6', 'groupId': 'BG000'}, {'value': '67.1', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '67.5', 'spread': '8.33', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Doses Per Day of Monitored Medication', 'classes': [{'categories': [{'title': 'One Dose Per Day', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}, {'title': 'More Than One Dose Per Day', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants will be randomized at the first informational session in a 1:1 allocation to the intervention or to the control arm. Randomization will be stratified according to if a companion is or is not enrolled in the study with the participant and according to whether the glaucoma medication housed by the AdhereTech bottle is prescribed to be take once daily or more than once daily.', 'unitOfMeasure': 'Participants'}, {'title': 'Companion Status', 'classes': [{'categories': [{'title': 'Companion at Randomization', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'No Companion at Randomization', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants will be randomized at the first informational session in a 1:1 allocation to the intervention or to the control arm. Randomization will be stratified according to if a companion is or is not enrolled in the study with the participant and according to whether the glaucoma medication housed by the AdhereTech bottle is prescribed to be take once daily or more than once daily.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-09', 'size': 439861, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-15T11:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-01', 'studyFirstSubmitDate': '2017-01-18', 'resultsFirstSubmitDate': '2020-07-29', 'studyFirstSubmitQcDate': '2017-02-09', 'lastUpdatePostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-26', 'studyFirstPostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Newly Prescribed Glaucoma Therapy', 'timeFrame': '12 Months', 'description': 'Will the proportion of Veterans in the intervention arm that are prescribed more intensive glaucoma therapy be less than the proportion of Veterans in the control arm who are prescribed more intensive glaucoma therapy in the 12 months following the intervention? Baseline data collection will include cataloging the current glaucoma medication regimen prescribed to the participant. Chart abstractions will be performed at 12 months following the baseline visit and intensification of glaucoma therapy will be defined as either 1) the addition of another glaucoma medication to the baseline regimen, 2) recommendation for glaucoma laser treatment, or 3) recommendation for glaucoma surgery in the 12 months following the baseline visit .'}, {'measure': 'Total Cost at 6 Months', 'timeFrame': '6 months', 'description': 'The proportion of participants attaining equal or \\>80% adherence as measured by electronic monitor, total intervention and medical resource costs, and incremental cost effectiveness ratios comparing intervention to control at 6 months.'}, {'measure': 'VA Healthcare Workflow Effectiveness', 'timeFrame': '12 months', 'description': 'The investigators will investigate the overall workload impacts to the VA healthcare system. Cost estimates and labor time data collected will be combined with glaucoma prevalence rates among Veterans to estimate overall workload impacts to the VA healthcare system.'}, {'measure': 'Cost-effectiveness Compared to Usual Care for Cost Per Blindness Averted', 'timeFrame': '12 months', 'description': 'Will the intervention be cost-effectiveness compared to usual care for cost per blindness averted'}, {'measure': 'Within-Trial Cost-Effectiveness of Adherence', 'timeFrame': '6 months', 'description': 'Will the intervention be cost-effectiveness compared to usual care? Total cost was calculated by adding the mean medical resource cost per patient to the cost of the intervention ($549) or the control ($48), then multiplying the total by the number of patients per group (100)'}, {'measure': 'VA Workflow Effectiveness', 'timeFrame': '12 months', 'description': 'The investigators will investigate the overall workload impacts to the VA healthcare system.'}], 'primaryOutcomes': [{'measure': 'Proportion of Prescribed Glaucoma Medication Doses Taken on Schedule', 'timeFrame': 'Randomization to 6 Months', 'description': 'Will veterans randomized to the intervention have a greater proportion of prescribed glaucoma medication doses taken as measured by the electronic medication monitor in the 6 months following the intervention compared to Veterans randomized to the control arm? The electronic bottle records the date and time that the bottle is opened. For participants in the intervention arm only, a reminder through the electronic bottle will be activated. The outcome measure is the proportion of prescribed doses taken with a minimum of Zero and a maximum of One; where higher scores indicate more adherence.'}], 'secondaryOutcomes': [{'measure': 'VA Medical Resource Use and Costs', 'timeFrame': '6 months', 'description': 'The investigators will investigate the overall budget impacts to the VA healthcare system. The main intervention costs are labor inputs, consisting of the one-time fixed labor cost of training and the variable labor cost of conducting the adherence intervention. The VA healthcare system also incurs costs, such as administration, utilities, and custodial services that cannot be directly attributed to a given health care service but nonetheless should be included in the cost analysis.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glaucoma', 'Disease management', 'Smart bottle'], 'conditions': ['Glaucoma']}, 'referencesModule': {'references': [{'pmid': '31157555', 'type': 'RESULT', 'citation': 'Hein AM, Rosdahl JA, Bosworth HB, Woolson SL, Olsen MK, Kirshner MA, Muir KW. The Association of an Upper Extremity Functional Survey and Glaucoma Medication Administration Success. Curr Eye Res. 2019 Oct;44(10):1150-1156. doi: 10.1080/02713683.2019.1625405. Epub 2019 Jun 11.'}, {'pmid': '33487050', 'type': 'RESULT', 'citation': 'Rosdahl JA, Hein AM, Bosworth HB, Woolson S, Olsen M, Kirshner M, Hung A, Muir KW. Randomized controlled trial of an education-based intervention to improve medication adherence: Design considerations in the medication adherence in glaucoma to improve care study. Clin Trials. 2021 Jun;18(3):343-350. doi: 10.1177/1740774520988291. Epub 2021 Jan 25.'}, {'pmid': '33892170', 'type': 'RESULT', 'citation': 'Muir KW, Rosdahl JA, Hein AM, Woolson S, Olsen MK, Kirshner M, Sexton M, Bosworth HB. Improved Glaucoma Medication Adherence in a Randomized Controlled Trial. Ophthalmol Glaucoma. 2022 Jan-Feb;5(1):40-46. doi: 10.1016/j.ogla.2021.04.006. Epub 2021 Apr 20.'}, {'pmid': '36002073', 'type': 'RESULT', 'citation': 'Williams AM, Theophanous C, Muir KW, Rosdahl JA, Woolson S, Olsen M, Bosworth HB, Hung A. Within-Trial Cost-Effectiveness of an Adherence-Enhancing Educational Intervention for Glaucoma. Am J Ophthalmol. 2022 Dec;244:216-227. doi: 10.1016/j.ajo.2022.08.011. Epub 2022 Aug 21.'}, {'pmid': '36603568', 'type': 'RESULT', 'citation': 'Buehne KL, Rosdahl JA, Hein AM, Woolson S, Olsen M, Kirshner M, Sexton M, Bosworth HB, Muir KW. How Medication Adherence Affects Disease Management in Veterans with Glaucoma: Lessons Learned from a Clinical Trial. Ophthalmic Res. 2023;66(1):489-495. doi: 10.1159/000528857. Epub 2023 Jan 5.'}], 'seeAlsoLinks': [{'url': 'http://www.eyecareamerica.org/news/press/', 'label': 'Intervention Arm Content Video testimonial from a glaucoma patient'}]}, 'descriptionModule': {'briefSummary': 'The proposed study is a randomized controlled trial enrolling Veterans with medically treated glaucoma who report less than 100% adherence to the prescribed glaucoma therapy. Participants will be randomized to receive either a one-on-one session with a member of the research team discussing the disease process and strategies for administering eye drops (intervention) or a one-on-one session with a member of the research team discussing general eye health (control). All participants will be provided with a "smart bottle" to house their glaucoma medications. The smart bottle records the date and time that the bottle is opened. For participants in the intervention arm only, a reminder function will be activated. The proportion or prescribed doses taken according to the monitor will be compared for the two groups.', 'detailedDescription': 'The purpose if this study is to improve glaucoma medication adherence in Veterans with medically-treated glaucoma. The study design is a single-site randomized controlled trial. Specific Aim 1. Evaluate the impact of an intervention to improve glaucoma medication adherence among Veterans at 6-month follow up.\n\nHypothesis 1: Veterans randomized to the intervention will have a greater proportion of prescribed glaucoma medication doses taken as measured by the electronic medication monitor in the 6 months following the intervention compared to Veterans randomized to the control arm.\n\nThe primary outcome for hypothesis 1A is the proportion of prescribed doses taken according to the electronic monitor. Participants in both arms will receive the electronic monitor or "smart bottle," which wirelessly transmits the date and time of opening of the smart bottle to the study team. From these medication events, the proportion of prescribed doses will be derived, defined as the ratio of the number of times the smart bottle was opened to the required number of doses prescribed according to the medical record over the period of time that the bottle is in use. For example, if a participant is advised to take his or her glaucoma drop twice a day for the 180 days that the bottle is in use and the smart bottle reveals 135 openings over the same time period, the proportion of prescribed doses taken is 37.5%.\n\nSpecific Aim 2. Evaluate the impact of the intervention on intensification of glaucoma therapy among Veterans at 12-month follow-up.\n\nHypothesis 2: The proportion of Veterans in the intervention arm that are prescribed more intensive glaucoma therapy, defined as addition of adjuvant glaucoma medication or recommendation for laser or glaucoma surgery will be less than the proportion of Veterans in the control arm who are prescribed more intensive glaucoma therapy in the 12 months following the intervention.\n\nBaseline data collection will include cataloging the current glaucoma medication regimen prescribed to the participant. Chart abstractions will be performed at 12 months following the baseline visit and intensification of glaucoma therapy will be defined as either 1) the addition of another glaucoma medication to the baseline regimen, 2) recommendation for glaucoma laser treatment, or 3) recommendation for glaucoma surgery in the 12 months following the baseline visit . The investigators will collect these data at 12 months because the Metrics study suggested that 55% of participants in the control arm will have intensification of therapy within one year.\n\nSpecific Aim 3. Evaluate the incremental cost-effectiveness and budget and workflow impacts of the intervention compared to usual care.\n\nHypothesis 3: The intervention will be cost-effectiveness for the following ratios: 1) cost per percentage improvement in medication adherence; 2) cost per blindness averted; and 3) cost per quality-adjusted-life years saved.\n\nA direct measurement approach will be used to estimate per-patient intervention and control arm costs. Glaucoma-related health care utilization costs will be derived from VA administrative datasets. The cost estimates will be combined with observed improvement in medication adherence and reduction in escalation in therapy to estimate the first two incremental cost effectiveness ratios. Simulation using Markov modeling will be used to estimate the incremental cost per blindness averted and quality-adjusted life years (QALYs) gained. Cost estimates and labor time data collected will be combined with glaucoma prevalence rates among Veterans to estimate overall budget and workload impacts to the VA healthcare system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of open angle glaucoma \\[primary open angle glaucoma, pigment dispersion glaucoma, pseudoexfoliation glaucoma, combined mechanism glaucoma, low tension glaucoma\\] recorded in the medical record\n* Prescribed glaucoma eye drops,\n* Visual field performed within the last 9 months.\n\n * As visual field testing is standard care glaucoma and the investigators wish to establish baseline glaucoma severity, the investigators will require that subjects have a visual field test documented in the chart within 9 months of enrollment.\n\nExclusion Criteria:\n\nExclusion criteria for patients At Screener:\n\n* "How confident are you that you always remember to use your glaucoma medications?"\n\n * not at all confident\n * somewhat confident\n * very confident)\n* And "In the past 4 weeks, did you ever forget to take your medicine?"\n\n * Veterans who respond both "very confident" and "no", respectively, will be excluded\n\nInclusion criteria for companions at screener:\n\n* Willing to participate in assisting the patient with glaucoma drops and\n* Willing to accompany the patient to the intervention visit for participants in the intervention arm or eye health education visit for participants in the control arm.\n\nExclusion criteria for companions: Unable or unwilling to attend baseline visit and intervention or control arm educational session with patient participant.\n\nExclusion criteria for patients or companions:\n\n* Lacks proficiency in English,\n* Lacks either a cell phone or landline phone.\n\nExclusion criteria for patients post randomization:\n\n* Decision by patient and provider to cease glaucoma medication use\n* Change in functional status such that the drops are no longer administered by the patient or the companion (such as nursing home care)'}, 'identificationModule': {'nctId': 'NCT03052257', 'acronym': 'MAGIC', 'briefTitle': 'Improve Glaucoma Medication Adherence', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Improving Glaucoma Medication Adherence', 'orgStudyIdInfo': {'id': 'IIR 15-113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Participants will be randomized to receive either a general eye health educational session (control arm) or an educational intervention developed to improve glaucoma medication adherence (intervention arm). All participants will be provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle records the date and time that the bottle is opened.', 'interventionNames': ['Behavioral: Educational - glaucoma', 'Behavioral: Dose monitoring and reminder']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Participants will be randomized to receive either a general eye health educational session (control arm) or an educational intervention developed to improve glaucoma medication adherence (intervention arm). All participants will be provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle records the date and time that the bottle is opened.', 'interventionNames': ['Behavioral: Educational - general', 'Behavioral: Dose monitoring']}], 'interventions': [{'name': 'Educational - glaucoma', 'type': 'BEHAVIORAL', 'description': "Discussion of glaucoma and the potential for blindness, facilitated by the glaucoma educator using a 3-dimensional model eye and photographic representation of glaucomatous vision loss; One-one-one demonstration of eye drop instillation techniques, Provision of a mnemonic aid which alerts the participant to missed doses; Review of the participant manual: An illustrated brochure on glaucoma and eye drop instillation. An individualized schedule for dosing of glaucoma medications. Individualized suggestions for improving adherence based on the subject's responses to the (SASES).", 'armGroupLabels': ['Intervention']}, {'name': 'Dose monitoring and reminder', 'type': 'BEHAVIORAL', 'otherNames': ['Smart bottle reminder'], 'description': 'Participants will be provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle records the date and time that the bottle is opened. For participants in the intervention arm only, a reminder through AdhereTech will be activated.', 'armGroupLabels': ['Intervention']}, {'name': 'Educational - general', 'type': 'BEHAVIORAL', 'description': 'The control information session will include review of a Powerpoint presentation on general eye health, including but not specific to glaucoma.', 'armGroupLabels': ['Control']}, {'name': 'Dose monitoring', 'type': 'BEHAVIORAL', 'otherNames': ['Smart bottle'], 'description': 'Participants will be provided with a "smart bottle" to house one of their glaucoma medications. The smart bottle records the date and time that the bottle is opened.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Durham VA Medical Center, Durham, NC', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Kelly W. Muir, MD MHSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Durham VA Medical Center, Durham, NC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}