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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03266003
Recruitment Status : Active, not recruiting
First Posted : August 29, 2017
Last Update Posted : January 28, 2020
Sponsor:
Collaborators:
New York City Department of Health and Mental Hygiene
Columbia University
Information provided by (Responsible Party):
Centers for Disease Control and Prevention

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.

Condition or disease Intervention/treatment Phase
Tuberculosis Drug-resistant Tuberculosis Adherence, Medication Adherence, Patient Other: Electronic DOT Other: In-person DOT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: An Evaluation of Traditional Directly Observed Therapy and Electronic Forms of Directly Observed Therapy for Tuberculosis Treatment
Actual Study Start Date : July 19, 2017
Actual Primary Completion Date : January 10, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
Group 1: ipDOT followed by eDOT
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
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).
Other Names:
  • eDOT
  • Video DOT (VDOT)

Other: In-person DOT
A trained person is in the physical presence of patients as anti-TB drugs are ingested.
Other Names:
  • ipDOT
  • Traditional DOT

Group 2: eDOT followed by ipDOT
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
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).
Other Names:
  • eDOT
  • Video DOT (VDOT)

Other: In-person DOT
A trained person is in the physical presence of patients as anti-TB drugs are ingested.
Other Names:
  • ipDOT
  • Traditional DOT




Primary Outcome Measures :
  1. Proportion of medication doses directly observed [ Time Frame: 6 months ]
    The proportion of medication doses that are directly observed by staff.


Secondary Outcome Measures :
  1. Proportion of medication doses not directly observed [ Time Frame: 6 months ]
    The proportion of medication doses not directly observed due to equipment malfunction or loss, staff unavailability, patient travel/ work/ school, inclement weather, or other reasons.

  2. Medication side effects [ Time Frame: Up to 13 weeks ]
    Time, measured in days, in which participants experience initial symptoms of medication side effects to when they receive medical attention for the medication side effects they are experiencing, either through consultation with a physician, urgent care or emergency room visits, or hospital admission across DOT methods.


Other Outcome Measures:
  1. Patients' demographic, social, and medical characteristics associated with treatment adherence [ Time Frame: 6 months ]
    Number of participants by gender, race, ethnic origin, country of birth, primary language spoken, and employment who adhere to TB treatment. Additionally, the number of patients with a history of contact with persons diagnosed with multi-drug resistant TB, incomplete treatment for latent TB infection, diabetes, renal disease, immunosuppression, hepatitis, a history of homelessness, a history of substance abuse, a history of incarceration, a history of a prior TB diagnosis who adhere to TB treatment.

  2. Treatment outcomes [ Time Frame: 6 months ]
    Compare the proportion of participants completing treatment to those lost to follow-up or refused further treatment, transfer or move, experience treatment failure, or expire (with death attributable to tuberculosis) across DOT methods.

  3. Participants' preferred DOT method at the conclusion of the cross-over period. [ Time Frame: 8 -13 weeks ]
    After participants complete 40 doses of TB medication (20 doses using ipDOT and 20 doses using eDOT) during the cross-over period, they will be asked to report which DOT method they prefer, and the reasons for their preference.

  4. Patient Opinion Questionnaire [ Time Frame: 8-13 weeks ]
    After participants complete 40 doses of TB medication (20 doses using ipDOT and 20 doses using eDOT), participants will be asked to complete the Patient Opinion Questionnaire to assess their perceptions of the quality of care across DOT methods and satisfaction with patient-staff relationships/rapport.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Individuals must meet the following inclusion criteria in order to participate in this study:

  1. 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.
  2. Physician determines the patient may be treated with any treatment regimen for non-rifamycin resistant TB approved by the NYC DOHMH TB program.
  3. Individuals found to have Isoniazid (INH) resistant disease are eligible for inclusion.
  4. Age >18 years or older
  5. Age 12 to 17 years, with the consent of a parent or legal guardian
  6. 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.
  7. No plans to move out of the catchment areas of the participating TB program sites within 9 months of enrollment.
  8. Willingness to comply with study procedures and provide written informed consent prior to study enrollment.
  9. Individuals for whom a diagnosis of TB has been made clinically are eligible for study inclusion. Data may be collected from these patients related to all objectives with the exception of culture conversion.

Exclusion Criteria:

An individual meeting any of the following exclusion criteria at the time of enrollment will be excluded from study participation:

  1. 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.
  2. Prescribed any injectable, anti-TB medication as part of an outpatient treatment regimen.
  3. 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.
  4. 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.
  5. Less than 12 years of age.
  6. Patients 12-17 years of age, whose parents or legal guardians refuse to provide consent.
  7. Incarceration, institutionalization, or other involuntary detention.
  8. Plans to move out of the catchment areas of the participating TB program sites in less than 9 months from the day of enrollment.
  9. Previously enrolled in this study.
  10. Currently enrolled in a clinical trial that prohibits enrollment in another study.
  11. Other medical conditions that, in the investigator's or the clinic physician's judgment, make study participation not in the individual's best interest.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03266003


Locations
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United States, New York
Morrisania Chest Center
Bronx, New York, United States, 10456
Fort Greene Chest Center
Brooklyn, New York, United States, 11201
Corona Chest Center
Jackson Heights, New York, United States, 11372
Washington Heights Chest Center
New York, New York, United States, 10032
Sponsors and Collaborators
Centers for Disease Control and Prevention
New York City Department of Health and Mental Hygiene
Columbia University
Investigators
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Principal Investigator: Joseph Burzynski, MD, MPH New York City DOHMH, Bureau of Tuberculosis Control
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Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT03266003    
Other Study ID Numbers: CDC-6995.0
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Any proposal for additional analysis of study data must be agreed to in advance by the NYC DOHMH BTBC and CDC investigators.

These criteria will not apply to public-use data that have been made available in accordance with CDC's policy on data sharing. Persons who use publicly available data will be asked to acknowledge both the NYC DOHMH BTBC and CDC.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centers for Disease Control and Prevention:
Tuberculosis
Directly observed therapy
Adherence
Video assisted directly observed therapy
Electronic directly observed therapy
Mobile health
Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Multidrug-Resistant
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections