Clinical Trial: Wirelessly Observed Therapy in Comparison to Directly Observed Therapy for the Treatment of Tuberculosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Pilot Clinical Trial Characterizing Use of Ingestion Sensor Enabled Rifamate in Comparison to Directly Observed Therapy for the Treatment of Tuberculosis

Brief 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

Detailed Summary:

PHARMACOKINETIC (PK) SUBSTUDY

The 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.

The 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.


Sponsor: mHealth UCSD

Current Primary Outcome:

  • Step 1: Positive Detection Accuracy (PDA) [ Time Frame: 2 weeks ]
    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.
  • Step 2: Percentage of Witnessed Doses [ Time Frame: 16 weeks ]
    Determine the percentage of witnessed doses by DHFS and standard of care (SOC), respectively.


Original Primary Outcome:

  • Step 1: Positive Detection Accuracy (PDA) [ Time Frame: 2 weeks ]
    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. PDA will be based upon proper DHFS use. PDA will be determined using an intention-to-treat and an adjusted analysis.
  • Step 2: Percentage of Witnessed Doses [ Time Frame: 16 weeks ]
    Determine the percentage of witnessed doses by DHFS and standard of care (SOC), respectively. Witnessed doses by DHFS is defined as the total number of dose ingestions confirmed by DHFS, divided by the total number of prescribed witnessed dose ingestions for TB treatment. Witnessed doses by SOC is defined as the total number of dose ingestions that are actually witnessed by a healthcare worker, divided by the total number of prescribed witnessed dose ingestions for TB treatment.


Current Secondary Outcome: Characterize subject responses to post-study questionnaires to collect information regarding their experience with the DHFS and the usability of the system, using summary statistics. [ Time Frame: 16 weeks ]

Original Secondary Outcome: Characterize subject responses to post-study questionnaires to collect information regarding their experience with the DHFS and the usability of the system, using summary statistics. [ Time Frame: 16 weeks ]

Questionnaire responses by subjects will be examined by study reviewers from the AVRC to develop recommendations regarding the usability of the system. Responses to individual questions and grouped question responses (i.e., summary metrics across questions) will be defined to evaluate subject satisfaction with the DHFS system.


Information By: mHealth UCSD

Dates:
Date Received: October 8, 2013
Date Started: October 2013
Date Completion: December 2017
Last Updated: March 15, 2016
Last Verified: March 2016