Educational Video for Latent Tuberculosis

Overseen By Katia J Bruxvoort, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Must be taking: Isoniazid, Rifampin

Disqualifiers: Active TB

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a short, 3-minute educational video (LTBI video intervention) can help people complete their treatment for latent tuberculosis (LTBI), a condition where TB bacteria are present in the body but not causing symptoms. The goal is to determine if watching this video increases the likelihood of finishing prescribed medication compared to those who do not watch it. Adults prescribed treatment for LTBI at Kaiser Permanente Southern California may be suitable for this study. Participants will either receive the video link or continue with standard care, and researchers will monitor their treatment progress over a year. As an unphased trial, this study provides an opportunity to contribute to research that could enhance treatment adherence for LTBI patients.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on an educational video to improve treatment completion for latent tuberculosis, so it's best to consult with your healthcare provider for guidance.

What prior data suggests that this educational video intervention is safe for patients with latent tuberculosis?

Research has shown that educational videos can help TB patients adhere to their treatment plans and complete their medication. In this trial, participants face no health risk because they only watch a short video about treating latent TB infection (LTBI). This video aims to motivate patients to take all their prescribed medication by explaining its importance.

Since the intervention involves only an educational video, there are no side effects or safety concerns, unlike with a drug or medical procedure. The goal is to increase the number of people who complete their treatment, which is crucial for controlling TB. Watching the video offers a safe way to potentially improve health outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a fresh approach to improving treatment adherence for latent tuberculosis (LTBI). Unlike the standard of care, which typically involves medication without additional educational components, this trial uses an engaging video intervention. The video is designed to educate patients about the importance of completing LTBI treatment, aiming to boost understanding and motivation. By leveraging a brief, accessible format, this method could potentially enhance patient compliance and ultimately improve health outcomes.

What evidence suggests that this video intervention is effective for improving LTBI treatment completion?

Research has shown that educational videos can help people complete their treatment for latent tuberculosis infection (LTBI). In this trial, participants in the LTBI video intervention arm will watch a brief (~3 minute) video about the importance of taking and completing LTBI treatment. Studies have found that digital tools, like videos and reminders, assist patients in following their treatment plans. Specifically, patients who used video reminders were more likely to complete their medication. One study discovered that video interventions worked just as well as traditional methods in helping people finish their treatment. These findings suggest that a short educational video might help more people complete their LTBI treatment, preventing the disease from worsening. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

Adults who are members of Kaiser Permanente Southern California, diagnosed with latent tuberculosis (LTBI), and have been prescribed treatment. Participants must be at least 18 years old and not have an active TB diagnosis.

Inclusion Criteria

Active KSPC member

LTBI ICD-10 diagnosis code prior to prescription order: R76.11, R76.12, Z22.7

I have been prescribed medication for latent TB infection.

Exclusion Criteria

Active TB ICD-10 diagnosis code prior to prescription order: A15, A17, A18, A19

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are prescribed LTBI treatment and randomized to receive either a brief educational video or standard care

1 year

Follow-up

Participants are monitored for treatment initiation and completion, as well as video accessibility and understanding of treatment importance

1 year

What Are the Treatments Tested in This Trial?

Interventions

• LTBI video intervention

Trial Overview The trial is testing if a short educational video sent to patients via text or email can increase the completion rates of LTBI treatment compared to standard care without the video. Patients will be randomly assigned to either receive the video or continue with standard care.

How Is the Trial Designed?

Group I: LTBI video intervention Experimental Treatment 1 Intervention

Patients randomized to the intervention group will be sent an invitation with a link to watch a brief (\~3 minute video) about the importance of taking and completing LTBI treatment.

Group II: Standard care Active Control 1 Intervention

Patients who are randomized to receive standard of care will not receive any messages or have any contact with the research team.

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11045025/

Asynchronous Video Directly Observed Therapy to Monitor ... Latent tuberculosis infection treatment completion was similar between participants monitored by standard-of-care directly observed therapy and asynchronous ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/12/NCT05412212/Prot_000.pdf

STUDY PROTOCOL A brief educational video for patients ... LTBI treatment can effectively prevent reactivation and development of TB disease.3 However, as treatment courses are very long, many patients ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1386505622000016

Digital health use in latent tuberculosis infection care Voice and/or textual reminders and synchronous video call to improve LTBI treatment adherence were the most commonly examined digital health interventions.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9612707/

The impact, effectiveness and outcomes of targeted screening ... The impact, effectiveness and outcomes of targeted screening ... Screening and treatment for latent tuberculosis infection (LTBI) are key for TB control.

5. pure.johnshopkins.edu pure.johnshopkins.edu/en/publications/asynchronous-video-directly-observed-therapy-to-monitor-short-cou

Asynchronous Video Directly Observed Therapy to Monitor ... VDOT could be a useful tool to monitor short-course latent tuberculosis infection (LTBI) treatment. Methods. We conducted a prospective ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11946329/

Treatment Adherence and Outcomes in Patients with ... Telemedicine interventions have shown improvements in medication adherence, treatment completion, cure rates, and smear conversion among TB patients.

7. youtube.com youtube.com/watch?v=iN0yzM7WECU

Diagnosing Latent TB Infection (LTBI) Latent TB infection is a clinical diagnosis based on a patient's medical history prior exposure to TB disease.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1876034120304147

Advantage in privacy protection by using synchronous ... A comprehensive patient-centered DOT program enables high treatment adherence for the 9-month isoniazid LTBI treatment.

9. cdc.gov cdc.gov/mmwr/volumes/72/wr/mm7244a2.htm

Tuberculosis Testing and Latent Tuberculosis Infection Although recommended short-course LTBI treatment regimens are effective, safe, and associated with higher completion rates than are longer ...