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Could a smartphone replace the nurse? study tests video monitoring for TB treatment

NCT ID NCT03266003

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study compares two ways of making sure people with tuberculosis (TB) take their medicine correctly: traditional in-person observation by a healthcare worker versus electronic observation using live video or recorded videos on a computer or phone. The trial involves 216 TB patients in New York City. If the electronic method works as well as in-person visits, it could give patients and clinics a more convenient and cheaper option for monitoring treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
electronic directly observed therapy (eDOT) via live video or time-stamped recordings
What this could lead to
If eDOT works as well as in-person observation, it could offer a more flexible and cost-saving way to ensure TB patients take their medication correctly.
What could go wrong
This is a single-site study with 216 participants, so results may not apply broadly. eDOT may miss side effects or technical issues could reduce adherence monitoring.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

216 people

The number who actually took part.

Started

Jul 2017

Finished

Dec 2020

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Directly Observed Therapy drug-resistant tuberculosis Medication Adherence multidrug-resistant tuberculosis Patient Compliance tuberculosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Corona Chest Center

    Jackson Heights, New York, 11372, United States

  • Fort Greene Chest Center

    Brooklyn, New York, 11201, United States

  • Morrisania Chest Center

    The Bronx, New York, 10456, United States

  • Washington Heights Chest Center

    New York, New York, 10032, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.