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NCT01960257 · ClinicalTrials.gov registry record · Phase 4
Wirelessly Observed Therapy in Comparison to Directly Observed Therapy for the Treatment of Tuberculosis
A Phase 4 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 4
- Development phase
- 92
- Enrollment target
NCT01960257: Completed Phase 4 study, sponsored by University of California, San Diego.
NCT01960257 is a Phase 4 study that has completed, run by University of California, San Diego. The registered enrollment target is 92 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01960257, a Phase 4 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 92 participants
- Enrollment target
Study Summary
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. The 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. This 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. If 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.
Primary Outcome
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.
Interventions
- DEVICE Digital Health Feedback System
- OTHER SOC DOT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2013-10-25 |
| Est. Completion | 2017-01-31 |
| Phase | Phase 4 |
What the finished NCT01960257 record still lists
NCT01960257 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Digital Health Feedback System is the first listed.
NCT01960257 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01960257 about?
NCT01960257 is a clinical study titled "Wirelessly Observed Therapy in Comparison to Directly Observed Therapy for the Treatment of Tuberculosis". 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 wireless...
What is the current status of trial NCT01960257?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 92 participants. The study started on 2013-10-25. Estimated completion is 2017-01-31.
What interventions are being tested in trial NCT01960257?
The interventions under investigation include: Digital Health Feedback System (DEVICE), SOC DOT (OTHER).
Who is sponsoring clinical trial NCT01960257?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01960257's enrollment target sits among peer trials
92 876th of 2000 higher than 1,117 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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