Mobile video directly observed therapy

emocha Mobile Health Inc. has developed a mobile video directly observed therapy application enabling users to track dose-by-dose medication adherence asynchronously. In mobile video directly observed therapy, patients record videos of themselves taking their medication on a mobile device and submit the videos for review. Nurses monitor the videos and may either “accept” or “reject” each video based on patients taking the correct medication and dosage. During submission of videos, patients can see their progress, report any symptoms and side effects of the medication, message the reviewing nurse, or communicate with a transplant team member.

The nurse monitoring patient behaviours may escalate concerns to the patient’s transplant care provider. Importantly, emocha’s application allows for greater patient engagement, interaction, and encouragement than other mHealth interventions. Nurses reviewing videos may message patients to build rapport, offer encouragement, and interact with patients. Nurses are trained to assess submitted videos for potential concerns, each with an associated method of detection during video review, a response to the patient, communication with transplant team, and communication to study staff. The application allows evaluation of adherence, medication side effects, administration or drug problems, and patient health and safety issues. Based on the identified issue, the mode and frequency of communication with the patient and care team can be customised (email, phone call, or chat message).

Current study and procedures

We developed a pilot study to examine this 12-week asynchronous, mobile video directly observed therapy intervention with 10 adolescent heart transplant recipients who are at least 6 months post-transplant and experiencing difficulties with medication adherence. Adolescents aged 11–21, demonstrating difficulties with medication adherence (medication level variability index ^{Reference Shemesh, Bucuvalas and Anand3} > 2.0, recommendation of transplant team), and who are otherwise medically stable are eligible to participate. Medical stability will be determined by mutual agreement between the transplant social workers, attending physicians, transplant nurse practitioners, and other members of the transplant teams.

The consenting of patients will be done entirely virtually over the phone and documented using eConsent via RedCap. No research-specific clinic visits are required which contributes to patient safety, especially during the COVID-19 pandemic. Once consented, patients and parents will complete a pre-intervention survey to assess baseline health-related quality of life and adherence barriers. Patients will be given materials supporting their initial setup with the emocha app and walked through the process by a study team member. Study personnel will assist with downloading the mobile video directly observed therapy application and explain its functionalities. A transplant provider/coordinator on the study team will enter the participant’s prescribed medications and times in which they are scheduled to take the medications. A phone interview at 3 weeks will be performed by the study team to assess feasibility. At 12 weeks, patients will complete a post-intervention survey and exit interview. A flow chart explaining the training procedure, measurement points, study staff response to patient events, and emocha’s involvement over the course of the intervention are detailed in Figure 1.

Figure 1. Participant flow diagram.

Measurement

Data used to evaluate the intervention will be collected from several sources. Basic adolescent and family demographic and medical information will be collected from the electronic health record and parent questionnaire. We will collect data on post-intervention rejection episodes and hospitalisations, thus examining potential longitudinal impacts of the therapy. Medication adherence will be measured as a percentage of videos submitted by the participant and accepted by the study nurse. A medication level variability index score is a standard deviation value for the medication concentration level calculated from each patient’s immunosuppressant medication tacrolimus (i.e., Prograf or FK506) blood levels. Higher SD scores across multiple blood tests indicate greater variability in these values and decreased consistency with medication taking. ^{Reference Shemesh, Bucuvalas and Anand3} Medication level variability index scores both 6 months before and 6 months after the intervention will be calculated to examine long-term medication adherence.

Adolescent patient and parental questionnaires will be completed with study staff at baseline and at the completion of the intervention. These measures include general and disease-specific measures of health-related quality of life (PedsQL 4.0 Generic Core Scales and PedsQL 3.0 Transplant Module) ^{Reference Varni, Burwinkle, Seid and Skarr7,Reference Weissberg-Benchell, Zielinski and Rodgers8} as well as the Adolescent Medication Barriers Scale and Parent Medication Barriers Scale to assess perceived barriers to medication adherence. ^{Reference Simons and Blount9} The 3-week feasibility and 12-week post-intervention participant interviews include the Post Study System Usability Questionnaire, ^{Reference Lewis10} a validated measure used in the development of technological applications, to assess the usability of and experience with the emocha application.

Metrics of intervention feasibility will include consent rate and use of the mobile video directly observed therapy emocha application by patients during the first 3 weeks, ease of implementation into clinical workflow, and time spent by nurse coordinators each week.