Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-02-21 @ 8:27 AM
Study NCT ID:
NCT01960257
Status:
COMPLETED
Last Update Posted:
2021-05-12
First Post:
2013-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Wirelessly Observed Therapy in Comparison to Directly Observed Therapy for the Treatment of Tuberculosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shbrowne@health.ucsd.edu', 'phone': '619 543 8080', 'title': 'Dr. Sara H. Browne', 'organization': 'University of California, San Diego'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were assessed for 2 weeks in Stage 1 and up to 12 months in Stage 2, Through study completion, an average of 12 months, or similar.', 'eventGroups': [{'id': 'EG000', 'title': 'WOT+ SOC DOT', 'description': 'Digital Health Feedback System (DHFS) Rifamate (combination of isoniazid 150 mg and rifampin 300 mg) over-encapsulated with ingestion sensor - 2 capsules orally daily (QD) administered orally preferably on an empty stomach first thing in the morning for 10-16 weeks, depending on time left to complete TB treatment.\n\nDigital Health Feedback System: This intervention uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new technologies approved by the FDA, to collect information about patients taking their TB medications. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which provides information about when patients have taken their TB medications.', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 1, 'seriousNumAtRisk': 77, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Wirelessly Observed Therapy (WOT)', 'description': 'IS-enabled combination isoniazid 150 mg/rifampin 300 mg (IS-Rifamate) over-encapsulated with ingestion sensor - 2 capsules orally daily (QD) administered orally preferably on an empty stomach first thing in the morning for 10-16 weeks, depending on time left to complete TB treatment.\n\nDigital Health Feedback System: This intervention uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new technologies approved by the FDA, to collect information about patients taking their TB medications. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which provides information about when patients have taken their TB medications.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Directly Observed Therapy (DOT)', 'description': 'Isoniazid 300 mg -1 tablet orally QD plus rifampin 300 mg - 2 capsules orally QD, OR Rifamate (combination of isoniazid 150 mg and rifampin 300 mg) - 2 capsules orally QD preferably on an empty stomach first thing in the morning for 10-16 weeks, depending on time left to complete TB treatment.\n\nSOC DOT', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pruritus at patch site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Step 1: Positive Detection Accuracy (PDA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DHFS With IS-RM Plus SOC DOT', 'description': 'Initially all participants (n=77) received DHFS IS-RM in conjunction with witnessed medication doses (DOT) for 2-3 weeks to allow calculation of DHFS IS-RM PDA, and the 95% confidence interval (CI) was estimated using the bootstrap method with 10,000 samples.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '98.1', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', 'description': 'Determine positive detection accuracy (PDA, direct confirmation of TB medication ingestion) of the DHFS when compared to a healthcare worker witnessing actual TB medication ingestion.', 'unitOfMeasure': 'percentage of DHFS detected doses', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Positive Detection Accuracy (PDA): PDA is defined as DHFS detection of the ingestion of a dose of IS-RM when compared to a witnessed ingestion of the same dose of medication.'}, {'type': 'PRIMARY', 'title': 'Step 2: Percentage of Witnessed Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'units': 'Days', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Wirelessly Observed Therapy (WOT)', 'description': 'IS-Rifamate (combination of isoniazid 150 mg and rifampin 300 mg) co-encapsulated with ingestion sensor - 2 capsules orally daily (QD) administered orally preferably on an empty stomach first thing in the morning for 10-16 weeks, depending on time left to complete TB treatment.\n\nDigital Health Feedback System: This intervention uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new technologies approved by the FDA, to collect information about patients taking their TB medications. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which provides information about when patients have taken their TB medications.'}, {'id': 'OG001', 'title': 'SOC DOT', 'description': 'Isoniazid 300 mg -1 tablet orally QD plus rifampin 300 mg - 2 capsules orally QD, OR Rifamate (combination of isoniazid 150 mg and rifampin 300 mg) - 2 capsules orally QD preferably on an empty stomach first thing in the morning for 10-16 weeks, depending on time left to complete TB treatment.\n\nSOC DOT'}], 'classes': [{'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000', 'lowerLimit': '89', 'upperLimit': '96'}, {'value': '63.1', 'groupId': 'OG001', 'lowerLimit': '58', 'upperLimit': '67'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '16 weeks', 'description': 'Determine the percentage of witnessed doses by DHFS and standard of care (SOC), respectively.', 'unitOfMeasure': 'percentage of witnessed doses', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Days', 'denomUnitsSelected': 'Days', 'populationDescription': 'Observation days'}, {'type': 'SECONDARY', 'title': 'Characterize Subject Responses to Post-study Questionnaires to Collect Information Regarding Their Experience With the DHFS Using Summary Statistics.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: DHFS With IS-RM Plus SOC DOT', 'description': 'Initially all participants (n=77) received DHFS IS-RM in conjunction with witnessed medication doses (DOT) for 2-3 weeks to allow calculation of DHFS IS-RM PDA, and the 95% confidence interval (CI) was estimated using the bootstrap method with 10,000 samples.'}, {'id': 'OG001', 'title': 'Stage 2: DHFS With IS-RM', 'description': 'n=41 participants were randomized to the Intervention Group that used DHFS with IS-RM without concurrent DOT for TB treatment monitoring'}], 'classes': [{'categories': [{'measurements': [{'value': '75.3', 'groupId': 'OG000'}, {'value': '92.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2-3 weeks', 'description': 'Subject responses regarding satisfaction with the DHFS were reported on post study questionnaires regarding their experience with the DHFS and the usability of the system, using summary statistics. Areas evaluated may include ease of use, time needed to use the system, negative impressions, and changes to quality of life. Analyses of individual questions as well as summary metrics across questions were explored.\n\nPercentage of participants who reported being comfortable replacing the patch on their own', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Ease of use of the DHFS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'WOT+ SOC DOT', 'description': 'Digital Health Feedback System (DHFS) Rifamate (combination of isoniazid 150 mg and rifampin 300 mg) co-encapsulated with ingestion sensor - 2 capsules orally daily (QD) administered orally preferably on an empty stomach first thing in the morning for 10-16 weeks, depending on time left to complete TB treatment.\n\nDigital Health Feedback System: This intervention uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new technologies approved by the FDA, to collect information about patients taking their TB medications. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which provides information about when patients have taken their TB medications.'}, {'id': 'FG001', 'title': 'Wirelessly Observed Therapy (WOT)', 'description': 'IS-Rifamate (combination of isoniazid 150 mg and rifampin 300 mg) co-encapsulated with ingestion sensor - 2 capsules orally daily (QD) administered orally preferably on an empty stomach first thing in the morning for 10-16 weeks, depending on time left to complete TB treatment.'}, {'id': 'FG002', 'title': 'Directly Observed Therapy (DOT)', 'description': 'Isoniazid 300 mg -1 tablet orally QD plus rifampin 300 mg - 2 capsules orally QD, OR Rifamate (combination of isoniazid 150 mg and rifampin 300 mg) - 2 capsules orally QD preferably on an empty stomach first thing in the morning for 10-16 weeks, depending on time left to complete TB treatment.\n\nSOC DOT'}], 'periods': [{'title': 'Stage 1 (1-3 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Only participated in PK Substudy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Stage 2(1-4 Months, Not to Exceed 12wks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'In Stage 1, 92 participants screened, 77 were enrolled in WOT+ SOC DOT. Excluded from stage 2, n=16: 12 only participated in PK substudy, 3 withdrew consent and 1 withdrew due to AE.\n\nStage 2, 61 participants enrolled and were divided into 2 arms, 41 in WOT, and 20 in DOT.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ALL PARTICIPANTS', 'description': 'Digital Health Feedback System (DHFS) Rifamate (combination of isoniazid 150 mg and rifampin 300 mg) co-encapsulated with ingestion sensor - 2 capsules orally daily (QD) administered orally preferably on an empty stomach first thing in the morning for 10-16 weeks, depending on time left to complete TB treatment.\n\nIsoniazid 300 mg -1 tablet orally QD plus rifampin 300 mg - 2 capsules orally QD, OR Rifamate (combination of isoniazid 150 mg and rifampin 300 mg) - 2 capsules orally QD preferably on an empty stomach first thing in the morning for 10-16 weeks, depending on time left to complete TB treatment.\n\nSOC DOT\n\nDigital Health Feedback System: This intervention uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new technologies approved by the FDA, to collect information about patients taking their TB medications. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which provides information about when patients have taken their TB medications.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '43', 'spread': '17', 'groupId': 'BG000'}]}]}, {'title': 'Stage 2 WOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '41', 'spread': '16', 'groupId': 'BG000'}]}]}, {'title': 'Stage 2 DOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '45', 'spread': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Each row represents data collected for a particular group based on treatment assignment.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}, {'title': 'Stage 2 WOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'Stage 2 DOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Each row represents data collected for a particular group based on treatment assignment.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Stage 2 WOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Stage 2 DOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Each row represents data collected for a particular group based on treatment assignment.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Stage 2 WOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Stage 2 DOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Each row represents data collected for a particular group based on treatment assignment.'}, {'title': 'Employment status: full-time/part time', 'classes': [{'title': 'Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Full-time', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Part-time', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Unemployed', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Retired', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Unable to work (disabled)', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Stage 2 WOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Full-time', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Part-time', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Unemployed', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Retired', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unable to work (disabled)', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Stage 2 DOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Full-time', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Part-time', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unemployed', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Retired', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unable to work (disabled)', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Each row represents data collected for a particular group based on treatment assignment.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-03-25', 'size': 859980, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-03-23T11:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-10', 'studyFirstSubmitDate': '2013-10-08', 'resultsFirstSubmitDate': '2020-05-12', 'studyFirstSubmitQcDate': '2013-10-08', 'lastUpdatePostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-10', 'studyFirstPostDateStruct': {'date': '2013-10-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Step 1: Positive Detection Accuracy (PDA)', 'timeFrame': '2 weeks', 'description': 'Determine positive detection accuracy (PDA, direct confirmation of TB medication ingestion) of the DHFS when compared to a healthcare worker witnessing actual TB medication ingestion.'}, {'measure': 'Step 2: Percentage of Witnessed Doses', 'timeFrame': '16 weeks', 'description': 'Determine the percentage of witnessed doses by DHFS and standard of care (SOC), respectively.'}], 'secondaryOutcomes': [{'measure': 'Characterize Subject Responses to Post-study Questionnaires to Collect Information Regarding Their Experience With the DHFS Using Summary Statistics.', 'timeFrame': '2-3 weeks', 'description': 'Subject responses regarding satisfaction with the DHFS were reported on post study questionnaires regarding their experience with the DHFS and the usability of the system, using summary statistics. Areas evaluated may include ease of use, time needed to use the system, negative impressions, and changes to quality of life. Analyses of individual questions as well as summary metrics across questions were explored.\n\nPercentage of participants who reported being comfortable replacing the patch on their own'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tuberculosis', 'tuberculosis treatment', 'wirelessly observed therapy', 'proteus digital health', 'digital health feedback system'], 'conditions': ['Tuberculosis']}, 'referencesModule': {'references': [{'pmid': '31584944', 'type': 'DERIVED', 'citation': 'Browne SH, Umlauf A, Tucker AJ, Low J, Moser K, Gonzalez Garcia J, Peloquin CA, Blaschke T, Vaida F, Benson CA. Wirelessly observed therapy compared to directly observed therapy to confirm and support tuberculosis treatment adherence: A randomized controlled trial. PLoS Med. 2019 Oct 4;16(10):e1002891. doi: 10.1371/journal.pmed.1002891. eCollection 2019 Oct.'}]}, 'descriptionModule': {'briefSummary': 'This study uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new Proteus Digital Health (PDH) technologies approved by the FDA, to collect information about patients taking their TB medications. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which gives healthcare providers information about when patients have taken their TB medications. The advantage of the DHFS is that patients can take their medication where and when it is convenient for them, and do not have to wait for a nurse to directly observe them taking their medication.\n\nThe purpose of this study is to find out if using these new technologies works as well as the standard method of observing in person when patients take their TB medications. This study will also look at the costs of using a DHFS for TB medications, what patients and healthcare providers think about using it, and other factors that can determine when one approach works better than another.\n\nThis study has two parts. For the first part of the study (Step I), patients will have an initial screening visit and then, in one two-week period, they will have 4 study visits at the UCSD AntiViral Research Center (AVRC) and routine visits from Public Health Services (PHS) workers. This part of the study is designed to confirm that the DHFS is working correctly and is accurately collecting information about each dose of medication that patients take, and to understand what patients and healthcare providers think about using the DHFS.\n\nIf patients are eligible for the second part of the study (Step II) and want to continue, that will last another 8-14 weeks with an additional 4 study visits at the AVRC. In the second part of the study, patients will be randomized into one of the following two groups.\n\nGroup 1: TB treatment is monitored by continued use of the DHFS\n\nGroup 2: TB treatment is monitored by the standard methods used by PHS (DOT)\n\nThe second part of the study is designed to compare these two methods of observing patients taking their TB medications, what the relative costs of these methods are , and the perception by patients and/or healthcare providers of the ease of use of the novel technology.', 'detailedDescription': 'PHARMACOKINETIC (PK) SUBSTUDY\n\nThe purpose of the PK substudy is to prospectively evaluate the pharmacokinetic parameters of isoniazid (INH) and rifampin (RIF) concentrations derived from dosing with Rifamate when given in native format compared to over encapsulated, ingestion sensor-enabled format.\n\nThe UCSD substudy aims to co-enroll 12 patients with Phase 1- the two-week investigation period of the characteristics of use of DHFS and patient acceptability. These subjects will be randomized to start on either Phase 1 or on two weeks of native Rifamate followed by 24-hour PK sampling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Basic competency in understanding written and verbal information as it applies to DHFS use.\n* Persons undergoing treatment for TB that includes at least isoniazid and rifampin at the time of entry to Phase 1; of note, patients must be sputum smear negative at the time of study entry.\n* Laboratory values obtained by screening laboratories within 30 days of entry:\n\n * Absolute neutrophil count (ANC) \\>= 1,000/mm3.\n * Hemoglobin \\>= 9.0 g/dL.\n * Platelet count \\>= 75,000/mm3.\n * AST (SGOT), ALT (SGPT), and alkaline phosphatase \\<= 3 x ULN.\n * Total bilirubin \\<= 1.5 x ULN and direct bilirubin.\n* Females of childbearing potential must agree to use contraception throughout the study period.\n* Men and women age \\>= 18 years.\n* Eligible for anti-mycobacterial medications and in possession of prescriptions for isoniazid and rifampin, or Rifamate, as appropriate.\n* Willing to follow all protocol requirements.\n* Ability to use mobile device per investigator determination, and to wear PDH wearable sensor (i.e., no skin conditions precluding use).\n* Ability and willingness of subjects to give written informed consent.\n\nExclusion Criteria\n\n* Female who is pregnant or breast-feeding, or of childbearing potential and has a tuberculin positive test at screening and disagrees to use contraception throughout the study period.\n* Use of any of the prohibited medications or other non-informed medications within 30 days of study entry.\n* Known hypersensitivity to any of the study drugs.\n* Known sensitivity to skin adhesives.\n* Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the investigator, for at least 30 days prior to study entry (Day 0).\n* Evidence of any anti-mycobacterial resistance, clinical or genetic, prior to study entry. Resistance testing results must be available for review by the site investigator and study protocol team prior to enrollment to ensure that no exclusionary resistance exists.\n* Active drug or alcohol use, or dependence, or other conditions that, in the opinion of the site investigator, would interfere with adherence to study requirements.'}, 'identificationModule': {'nctId': 'NCT01960257', 'briefTitle': 'Wirelessly Observed Therapy in Comparison to Directly Observed Therapy for the Treatment of Tuberculosis', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'A Pilot Clinical Trial Characterizing Use of Ingestion Sensor Enabled Rifamate in Comparison to Directly Observed Therapy for the Treatment of Tuberculosis', 'orgStudyIdInfo': {'id': 'AHF TB 001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DHFS with IS-RM', 'description': 'Digital Health Feedback System (DHFS) Rifamate (combination of isoniazid 150 mg and rifampin 300 mg) over-encapsulated with ingestion sensor - 2 capsules orally daily (QD) administered orally preferably on an empty stomach first thing in the morning for 10-16 weeks, depending on time left to complete TB treatment.', 'interventionNames': ['Device: Digital Health Feedback System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SOC DOT', 'description': 'Isoniazid 300 mg -1 tablet orally QD plus rifampin 300 mg - 2 capsules orally QD, OR Rifamate (combination of isoniazid 150 mg and rifampin 300 mg) - 2 capsules orally QD preferably on an empty stomach first thing in the morning for 10-16 weeks, depending on time left to complete TB treatment.', 'interventionNames': ['Other: SOC DOT']}], 'interventions': [{'name': 'Digital Health Feedback System', 'type': 'DEVICE', 'otherNames': ['DHFS'], 'description': 'This intervention uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new technologies approved by the FDA, to collect information about patients taking their TB medications. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which provides information about when patients have taken their TB medications.', 'armGroupLabels': ['DHFS with IS-RM']}, {'name': 'SOC DOT', 'type': 'OTHER', 'armGroupLabels': ['SOC DOT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UCSD AntiViral Research Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92110', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego County Public Health Services', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Sara Browne, MD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'University of California, San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'Department of Health and Human Services', 'class': 'FED'}, {'name': 'Proteus Digital Health, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Research Associate', 'investigatorFullName': 'Sara H. Browne, MD, MPH', 'investigatorAffiliation': 'University of California, San Diego'}}}}