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

Phase 4

Completed

• Conditions: Tuberculosis
• Interventions: Device: Digital Health Feedback System; Other: SOC DOT

• Registration Number: NCT01960257
• Lead Sponsor: University of California, San Diego

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 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.

Group 1: TB treatment is monitored by continued use of the DHFS

Group 2: TB treatment is monitored by the standard methods used by PHS (DOT)

The 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-08
• Study First Posted: 2013-10-10
• Study Start: 2013-10-25
• Primary Completion: 2017-01-31
• Study Completion: 2017-01-31
• Results First Submitted: 2020-05-12
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-10
• Last Update Submitted: 2021-05-10
• Results First Posted: 2021-05-12
• Last Update Posted: 2021-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DHFS with IS-RM	Digital Health Feedback System	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.
SOC DOT	SOC DOT	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Characterize Subject Responses to Post-study Questionnaires to Collect Information Regarding Their Experience With the DHFS Using Summary Statistics.	2-3 weeks	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.; Percentage of participants who reported being comfortable replacing the patch on their own

Trial Locations

Locations (2)

San Diego County Public Health Services; 🇺🇸 San Diego, California, United States

UCSD AntiViral Research Center; 🇺🇸 San Diego, California, United States