TGH Transplant Institute researching how mobile technology can help patients

These days mobile apps help people do everything from get food delivered to manage their finances. So could a mobile health app help transplant patients maintain their health after a transplant?

That’s a question that Tampa General Hospital is helping to answer as one of 100 transplant centers nationwide participating in the TEAMMATE (Technology Enabled and Molecular Monitoring of the Allograft and Transplant rEcipient) study. It will be the largest ever digital study measuring the impact of AlloCare™, a tech-enabled mobile health app, on organ transplant patient outcomes.

The study will enroll 4,000 patients from more than 100 transplant centers nationwide as part of a prospective, randomized, controlled, multi-center study spanning kidney, heart, lung, and liver transplantation. Half of the participants will be enrolled in the study arm and half in the control arm. The study arm will have patients trained for regular use of the AlloCare mobile health app. The control arm will maintain the center’s standard of care. The primary endpoint will be 90-day readmission rates. The secondary endpoints will include medication adherence, blood pressure management, organ rejection at 3, 6, and 12 months, and patient satisfaction levels.

AlloCare is a patient management app that helps transplant recipients precisely manage their medications, schedule their lab work, track their blood pressure and other vital metrics, view test results measuring the function of their new organ, and connect with other transplant recipients. 

The TEAMMATE study is one of four that TGH is participating in involving CareDx, the company that created AlloCare. The others, designed to evaluate the effectiveness of using similar technology for smaller populations of patients, include:

• Kidney Allograft Outcomes AlloSure Registry (KOAR) – An observational study to evaluate safety and efficacy outcomes in kidney transplant recipients in whom post-transplant care is managed using AlloSure®, a test designed to help determine whether assess the probability of rejection. Early results show that patients using this monitoring tool have higher survival rates.
• KidneyCare Immuno-optimization for Renal Allografts (KIRA) – Study designed to assess the feasibility and safety of the KidneyCare platform in reducing immunosuppressant exposure without increasing the risk of clinical rejection or graft injury or loss.
• Molecular Assessment and Profiling of Liver Transplant Recipients (MAPLE) – This multi-center study will assess whether the LiverCare platform, which tracks various measures of organ health for transplant recipients, helps to improve their overall health outcomes. 

The TGH Transplant Institute also is conducting other research to help improve the health of transplant patients. Studies recently published by USF Health and TGH Transplant Institute physicians include: 

Successful Treatment of a Severe COVID-19 Patient Using an Integrated Approach Addressing Mast Cells and Their Mediators

ABSTRACT

SARS-CoV-2 infects cells leading to a complex immune response that involves the release of mediators, most of which are released from mast cells, leading to lung edema, fibrosis, inflammation, and micro thromboses, hallmarks of COVID-19. Here we report on a patient who was initially hospitalized with severe COVID-19 pneumonia, as well as physical and mental fatigue. In spite of her having been treated with albuterol, azithromycin, ceftriaxone, convalescent plasma and dexamethasone, she continued to worsen to the extent that she was considered for double lung transplant. Four months after a novel integrative treatment approach primarily aiming at inhibiting mast cells and their mediators, using rupatadine, famotidine, misoprostol, vitamin D3 luteolin, quercetin, and erythropoietin, the patient recovered fully.

Optimal Timing of Administration of Direct-acting Antivirals for Patients With Hepatitis C-associated Hepatocellular Carcinoma Undergoing Liver Transplantation

ABSTRACT

Objective: To investigate the optimal timing of direct acting antiviral (DAA) administration in patients with hepatitis C-associated hepatocellular carcinoma (HCC) undergoing liver transplantation (LT).
Summary of background data: In patients with hepatitis C (HCV) associated HCC undergoing LT, the optimal timing of direct-acting antivirals (DAA) administration to achieve sustained virologic response (SVR) and improved oncologic outcomes remains a topic of much debate.

Methods: The United States HCC LT Consortium (2015-2019) was reviewed for patients with primary HCV-associated HCC who underwent LT and received DAA therapy at 20 institutions. Primary outcomes were SVR and HCC recurrence-free survival (RFS).

Results: Of 857 patients, 725 were within Milan criteria. SVR was associated with improved 5-year RFS (92% vs 77%, P < 0.01). Patients who received DAAs pre-LT, 0-3 months post-LT, and ≥3 months post-LT had SVR rates of 91%, 92%, and 82%, and 5-year RFS of 93%, 94%, and 87%, respectively. Among 427 HCV treatment-naïve patients (no previous interferon therapy), patients who achieved SVR with DAAs had improved 5-year RFS (93% vs 76%, P < 0.01). Patients who received DAAs pre-LT, 0-3 months post-LT, and ≥3 months post-LT had SVR rates of 91%, 93%, and 78% (P < 0.01) and 5-year RFS of 93%, 100%, and 83% (P = 0.01).

Conclusions: The optimal timing of DAA therapy appears to be 0 to 3 months after LT for HCV-associated HCC, given increased rates of SVR and improved RFS. Delayed administration after transplant should be avoided. A prospective randomized controlled trial is warranted to validate these results.

For more information about research being conducted via the Tampa General Hospital – USF Health Office of Clinical Research, click here. For a complete list of clinical trials taking place at Tampa General Hospital, click here.