An Evaluation of Traditional Directly Observed Therapy (DOT) and Electronic DOT for TB Treatment

NCT03266003 | Completed

• 1 other identifier: CDC-6995.0
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 4

Brief Summary

This study is a U.S.-based, 1 site (with 4 clinical settings), randomized controlled trial (with funding from the Centers for Disease Control and Prevention's (CDC) Antibiotic Resistance Solutions Initiative) that will be implemented to evaluate traditional directly observed therapy (DOT) and electronic forms of DOT (eDOT) for tuberculosis (TB) treatment. The trial will assess whether eDOT that employs electronic communication methods, such as video via computer or cellphone, is a non-inferior approach to monitor TB treatment adherence, compared to traditional in-person DOT (ipDOT), in which a trained person is in the physical presence of patients as anti-TB drugs are ingested. ipDOT is the single best intervention proven to be successful when it comes to TB patients' adherence to therapy (which reduces risk of acquired drug resistance). However, ipDOT is resource intensive and many times challenging to facilitate in-person. If eDOT is found to be non-inferior to ipDOT, health departments and other clinicians might be able to provide eDOT to certain populations of TB patients in a more flexible and potentially cost-saving manner.

Conditions

Tuberculosis; Drug-resistant Tuberculosis; Adherence, Medication; Adherence, Patient

Keywords

Tuberculosis; Directly observed therapy; Adherence; Video assisted directly observed therapy; Electronic directly observed therapy; Mobile health

Outcome Measures

Primary Outcomes (1)

• Proportion of medication doses directly observed

  The proportion of medication doses that are directly observed by staff.

  6 months

Secondary Outcomes (2)

• Proportion of medication doses not directly observed

  6 months

• Medication side effects

  Up to 13 weeks

Other Outcomes (4)

• Patients' demographic, social, and medical characteristics associated with treatment adherence

  6 months

• Treatment outcomes

  6 months

• Participants' preferred DOT method at the conclusion of the cross-over period.

  8 -13 weeks

Study Arms (2)

Group 1: ipDOT followed by eDOT

OTHER

Following 20 observable medication doses under an initial DOT study group assignment of in-person DOT (ipDOT), patients will be assigned (crossed-over) to electronic DOT (eDOT) to collect data on another 20 observable medication doses.

Other: Electronic DOT; Other: In-person DOT

Group 2: eDOT followed by ipDOT

OTHER

Following 20 observable medication doses under an initial DOT study group assignment of electronic DOT (eDOT), patients will be assigned (crossed-over) to in-person DOT (ipDOT) to collect data on another 20 observable medication doses.

Other: Electronic DOT; Other: In-person DOT

Interventions

Electronic DOT OTHER

Electronic DOT is the use of electronic communication methods to observe patients swallow anti-TB drugs and monitor for medication side effects. This study will use two variations of electronic communication methods, referred to as "electronic directly observed therapy" or "eDOT". This includes: (1) eDOT conducted "live" in which TB program staff interact with patients via a computer or phone application as they ingest their medication (eDOT-live), and (2) eDOT conducted using "time stamped, recorded" videos in which TB program staff log into an electronic system and review videos recorded by patients in order to verify that patients ingested their medication doses as scheduled (eDOT-recorded).

Also known as: eDOT, Video DOT (VDOT)

Group 1: ipDOT followed by eDOT; Group 2: eDOT followed by ipDOT

In-person DOT OTHER

A trained person is in the physical presence of patients as anti-TB drugs are ingested.

Also known as: ipDOT, Traditional DOT

Group 1: ipDOT followed by eDOT; Group 2: eDOT followed by ipDOT

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All TB patients (both those with a confirmed diagnosis and those with a clinical diagnosis), started on treatment for non-rifamycin resistant TB, and eligible to receive DOT.
• Physician determines the patient may be treated with any treatment regimen for non-rifamycin resistant TB approved by the NYC DOHMH TB program.
• Age \>18 years or older
• Age 12 to 17 years, with the consent of a parent or legal guardian
• An address or residence location that is readily accessible for visiting, and willingness to inform the study team of any change of address during the treatment and follow-up period.
• No plans to move out of the catchment areas of the participating TB program sites within 9 months of enrollment.
• Willingness to comply with study procedures and provide written informed consent prior to study enrollment.

You may not qualify if:

• At the time of enrollment, the patient's Mtb isolate is already known to be resistant to rifamycin or prescribed a non-rifamycin treatment regimen.
• Prescribed any injectable, anti-TB medication as part of an outpatient treatment regimen.
• Adverse reaction to initial doses of anti-TB medication (per NYC protocol) of sufficient severity that in the judgement of the clinician makes study participation not in the individual's best interest.
• A cognitive or physical disability that prevents full participation in eDOT (e.g., vision, hearing, physically challenged, inability to swallow medications). Note: Exceptions will be made for those patients who crush pills in order to swallow the medication, or have a member of their household or a caregiver who can assist them for the duration of the study.
• Less than 12 years of age.
• Patients 12-17 years of age, whose parents or legal guardians refuse to provide consent.
• Incarceration, institutionalization, or other involuntary detention.
• Plans to move out of the catchment areas of the participating TB program sites in less than 9 months from the day of enrollment.
• Previously enrolled in this study.
• Currently enrolled in a clinical trial that prohibits enrollment in another study.
• Other medical conditions that, in the investigator's or the clinic physician's judgment, make study participation not in the individual's best interest.

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• New York City Department of Health and Mental Hygiene: collaborator
• Columbia University: collaborator

Study Sites (4)

Fort Greene Chest Center

Brooklyn, New York, 11201, United States

Location

Corona Chest Center

Jackson Heights, New York, 11372, United States

Location

Washington Heights Chest Center

New York, New York, 10032, United States

Location

Morrisania Chest Center

The Bronx, New York, 10456, United States

Location

Related Publications (2)

• Mangan JM, Burzynski J, deCastro BR, Salerno MM, Lam CK, Macaraig M, Reaves M, Kiskadden-Bechtel S, Bowers S, Sathi C, Dias MP, Goswami ND, Vernon A. Challenges associated with electronic and in-person directly observed therapy during a randomized trial. Int J Tuberc Lung Dis. 2023 Apr 1;27(4):298-307. doi: 10.5588/ijtld.22.0583.

  PMID: 37035970 DERIVED

• Burzynski J, Mangan JM, Lam CK, Macaraig M, Salerno MM, deCastro BR, Goswami ND, Lin CY, Schluger NW, Vernon A; eDOT Study Team. In-Person vs Electronic Directly Observed Therapy for Tuberculosis Treatment Adherence: A Randomized Noninferiority Trial. JAMA Netw Open. 2022 Jan 4;5(1):e2144210. doi: 10.1001/jamanetworkopen.2021.44210.

  PMID: 35050357 DERIVED

MeSH Terms

Conditions

Tuberculosis; Tuberculosis, Multidrug-Resistant; Medication Adherence; Patient Compliance; Directly Observed Therapy

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Joseph Burzynski, MD, MPH

  New York City DOHMH, Bureau of Tuberculosis Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: August 29, 2017
• Study Start: July 19, 2017
• Primary Completion: January 10, 2020
• Study Completion: December 31, 2020
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

US (4)