SBIR-STTR Award

The Development and Assessment of Video-Based Directly Observed Treatment for Tuberculosis (TB) is a project to develop a patient-centered, cost-saving alternative strategy to ensure TB treatment completion. TB disproportionately affects vulnerable populations, and there are barriers to TB care. `Directly observed therapy' (DOT) is the recommended standard for all TB patients to enhance adherence. However, DOT is labor-intensive, expensive, and can be burdensome and stigmatizing for patients. An alternative strategy is to view patients taking TB therapy `at a distance' using video recorded at a patient's convenience using mobile devices. Videos are observed by clinicians to verify that medication was taken. The small business, emocha Mobile Health Inc., and Johns Hopkins University have created a prototype called miDOT (mobile internet DOT) to allow video-based DOT and TB monitoring. This proposal will further product development to allow broad TB program implementation and commercialization, with customization to reduce TB related health disparities. Project sites include Public Health TB clinics in Baltimore City, Baltimore County, and Anne Arundel County, Maryland. In Aim 1, we will conduct a baseline comprehensive needs assessment of TB patients and program staff. The objective is to establish a software development plan by assessing technological readiness of TB programs and patients, establish minimum infrastructure requirements and clinical systems integration needs, and analyze logistical, cultural, and financial barriers to TB care that can be reduced using a video-DOT approach. In Aim 2, an optimized product for video-DOT and TB management will be developed. The current prototype will be improved based on Aim 1 data to create a `beta' miDOT version. User-testing of the `beta' application will be conducted among TB patients and staff to gather additional user feedback and guide further product optimization. In Aim 3, the optimized version of miDOT will be implemented in TB clinics to demonstrate effectiveness and to conduct a cost analysis. In a pilot prospective study, the proportion of expected doses of TB therapy that can be verified/observed using miDOT will be compared to a cohort receiving standard DOT services. In addition, a cost analysis will assess the patient and health system costs associated with using miDOT compared to costs associated with standard DOT. Patient and staff satisfaction with miDOT as an alternative to standard DOT services will be assessed. Project success will be enhanced through strong collaborations between emocha, Johns Hopkins University investigators, and Public Health Department TB programs. The investigative team has significant experience in product and business development, TB clinical research, public health, and development and evaluation of mHealth interventions. Completion of grant activities will lead to an optimized product to allow video-based DOT that overcomes current health disparities in TB care.

Public Health Relevance Statement:


Public Health Relevance:
The proposed study will develop and evaluate video-based Directly Observed Treatment (DOT) strategies in Public Health Tuberculosis (TB) Clinics to improve care. Video-DOT offers the benefit of patient convenience, potential for reduced stigma from a disease that disproportionately affects vulnerable populations, and reduced health care staff time and expense. The proposal will optimize a video-based DOT platform and will evaluate the effectiveness and costs of video-DOT as an alternative to conventional DOT.

Project Terms:
Address; Adherence (attribute); Affect; Baltimore; base; Businesses; Caring; Case Management; Centers for Disease Control and Prevention (U.S.); Cities; Clinic; Clinical; Clinical Research; cohort; Collaborations; commercialization; Communication; Computerized Medical Record; Computers; cost; Cost Analysis; cost effectiveness; County; Data; Development; Development Plans; Directly Observed Therapy; Disadvantaged; Disease; disorder prevention; Dose; economic impact; Economics; Effectiveness; Ensure; Evaluation; experience; Face; Feedback; Goals; Grant; handheld mobile device; Health; health disparity; Health system; Healthcare; improved; Individual; Information Systems; Ingestion; innovation; Internet; interoperability; Intervention; Interview; Knowledge; Lead; Maryland; medication compliance; mHealth; Minority; Monitor; Morbidity - disease rate; Mortality Vital Statistics; Needs Assessment; patient oriented; Patients; Persons; Pharmaceutical Preparations; Phase; product development; programs; Prospective Studies; prototype; public health medicine (field); public health relevance; Questionnaires; Readiness; Research Infrastructure; Research Personnel; satisfaction; Schedule; Secure; Services; Site; social stigma; software development; standard of care; Structure; success; System; Systems Integration; Technology; Testing; Texas; Time; transmission process; treatment adherence; treatment strategy; Tuberculosis; tuberculosis treatment; Universities; Update; user-friendly; Video Recording; Vulnerable Populations; web site; Work; World Health Organization

The Development and Assessment of Video-Based Directly Observed Treatment for Tuberculosis (TB) is a project to develop a patient-centered, cost-saving alternative strategy to ensure TB treatment completion. TB disproportionately affects vulnerable populations, and there are barriers to TB care. `Directly observed therapy' (DOT) is the recommended standard for all TB patients to enhance adherence. However, DOT is labor-intensive, expensive, and can be burdensome and stigmatizing for patients. An alternative strategy is to view patients taking TB therapy `at a distance' using video recorded at a patient's convenience using mobile devices. Videos are observed by clinicians to verify that medication was taken. The small business, emocha Mobile Health Inc., and Johns Hopkins University have created a prototype called miDOT (mobile internet DOT) to allow video-based DOT and TB monitoring. This proposal will further product development to allow broad TB program implementation and commercialization, with customization to reduce TB related health disparities. Project sites include Public Health TB clinics in Baltimore City, Baltimore County, and Anne Arundel County, Maryland. In Aim 1, we will conduct a baseline comprehensive needs assessment of TB patients and program staff. The objective is to establish a software development plan by assessing technological readiness of TB programs and patients, establish minimum infrastructure requirements and clinical systems integration needs, and analyze logistical, cultural, and financial barriers to TB care that can be reduced using a video-DOT approach. In Aim 2, an optimized product for video-DOT and TB management will be developed. The current prototype will be improved based on Aim 1 data to create a `beta' miDOT version. User-testing of the `beta' application will be conducted among TB patients and staff to gather additional user feedback and guide further product optimization. In Aim 3, the optimized version of miDOT will be implemented in TB clinics to demonstrate effectiveness and to conduct a cost analysis. In a pilot prospective study, the proportion of expected doses of TB therapy that can be verified/observed using miDOT will be compared to a cohort receiving standard DOT services. In addition, a cost analysis will assess the patient and health system costs associated with using miDOT compared to costs associated with standard DOT. Patient and staff satisfaction with miDOT as an alternative to standard DOT services will be assessed. Project success will be enhanced through strong collaborations between emocha, Johns Hopkins University investigators, and Public Health Department TB programs. The investigative team has significant experience in product and business development, TB clinical research, public health, and development and evaluation of mHealth interventions. Completion of grant activities will lead to an optimized product to allow video-based DOT that overcomes current health disparities in TB care.

Public Health Relevance Statement:


Public Health Relevance:
The proposed study will develop and evaluate video-based Directly Observed Treatment (DOT) strategies in Public Health Tuberculosis (TB) Clinics to improve care. Video-DOT offers the benefit of patient convenience, potential for reduced stigma from a disease that disproportionately affects vulnerable populations, and reduced health care staff time and expense. The proposal will optimize a video-based DOT platform and will evaluate the effectiveness and costs of video-DOT as an alternative to conventional DOT.

NIH Spending Category:
Clinical Research; Infectious Diseases; Networking and Information Technology R&D; Orphan Drug; Rare Diseases; Tuberculosis

Project Terms:
Address; Adherence; Affect; Baltimore; base; Businesses; Caring; Case Management; Centers for Disease Control and Prevention (U.S.); Cities; Clinic; Clinical; Clinical Research; cohort; Collaborations; commercialization; Communication; Computerized Medical Record; Computers; cost; Cost Analysis; cost effectiveness; County; Data; Development; Development Plans; Directly Observed Therapy; Disadvantaged; Disease; disorder prevention; Dose; economic impact; Economics; Effectiveness; Ensure; Evaluation; experience; Face; Feedback; Goals; Grant; handheld mobile device; Health; health disparity; Health system; Healthcare; improved; Individual; Information Systems; Ingestion; innovation; Internet; interoperability; Intervention; Interview; Knowledge; Lead; Maryland; medication compliance; mHealth; Monitor; Morbidity - disease rate; mortality; Needs Assessment; patient oriented; Patients; Persons; Pharmaceutical Preparations; Phase; product development; programs; Prospective Studies; prototype; Public Health; Questionnaires; racial minority; Readiness; Research Infrastructure; Research Personnel; satisfaction; Schedule; Secure; Services; Site; social stigma; software development; standard of care; Structure; success; System; Systems Integration; Technology; Testing; Texas; Time; transmission process; treatment adherence; treatment strategy; Tuberculosis; tuberculosis treatment; Universities; Update; user-friendly; Video Recording; Vulnerable Populations; web site; Work; World Health Organization