SBIR-STTR Award

Outcomes following solid organ transplantation (SOT) are generally excellent with 5-year survival exceeding 85% for most graft types and age groups. Immunosuppression nonadherence is an important factor leading to graft failure and patient mortality in SOT recipients since individuals are required to make a lifelong commitment to a strict medication schedule. Nonadherence has been reported to range from 15 to 40% among liver patients and more than 30% among kidney patients. Mobile applications (“apps”) provide a low-cost and scalable opportunity to improve medication adherence through more consistent monitoring, earlier detection of nonadherence, and frequent patient-provider communication with nonadherent patients. We have developed a patient-facing mHealth app, mDOT for Transplantation, that enables patients to view their immunosuppression regimen, record themselves taking doses of their medication, track and visualize progress on their own and with their transplant coordinator, document symptoms and side effects, and access educational content. There is a transplant provider web- based platform where they can review patient submitted videos, provide feedback about accepting the video as evidence of adherence, and receive notifications when patients report symptoms. The proposed project seeks to optimize this tool to increase medication adherence in transplant recipients. The aims of the project are: 1) to enhance mDOT for Transplantation with 2-way patient-provider communication/messaging capabilities and standardized text messages to promote behavior change and 2) to perform a pilot randomized controlled trial of mDOT for Transplantation compared to standard-of-care in SOT patients.

Public Health Relevance Statement:
Project Narrative Immunosuppression nonadherence is a leading cause of rejection, de novo DSA, graft loss, and death among kidney and liver transplant recipients. 30-80% of kidney and liver transplant recipients are nonadherent to their immunosuppression medications. We have developed a patient-facing mHealth app that enables patients to view their immunosuppression regimen, record themselves taking doses of their medication, track and visualize progress on their own and with their transplant coordinator, document symptoms and side effects, and access educational content. The goal of this project is to 1) optimize this system with two-way communication capacity in order to foster greater patient-provider engagement and 2) conduct a randomized controlled trial to compare medication adherence between app users and standard-of-care patients.

NIH Spending Category:
Behavioral and Social Science; Clinical Research; Clinical Trials and Supportive Activities; Digestive Diseases; Health Disparities; Health Services; Immunotherapy; Kidney Disease; Liver Disease; Minority Health; Networking and Information Technology R&D (NITRD); Organ Transplantation; Patient Safety; Transplantation

Project Terms:
Acute; Address; Adherence; adherence rate; age group; American; behavior change; Behavioral; Birds; Car Phone; Caregivers; Case Management; Cessation of life; Chronic Disease; Clinical; Communication; Communities; Consensus; cost; Custom; Data; design; Development; Directly Observed Therapy; Dose; Early Diagnosis; Effectiveness; efficacy study; Ensure; Evaluation; Feedback; Fostering; Funding; Goals; graft failure; Guidelines; Health Personnel; Health Technology; Hepatitis C virus; Hospitalization; Immunosuppression; Immunosuppressive Agents; improved; Incentives; indexing; Individual; infectious disease treatment; Infrastructure; innovation; Intervention; Interview; Kidney; Kidney Transplantation; Liver; liver transplantation; medication compliance; medication nonadherence; mHealth; mobile application; Mobile Health Application; Monitor; mortality; Motivation; National Institute of Diabetes and Digestive and Kidney Diseases; Notification; Online Systems; Organ Transplantation; Outcome; Participant; Patient Care; Patient Noncompliance; patient oriented; Patient Self-Report; patient-clinician communication; Patients; Persuasive Communication; Pharmaceutical Preparations; Phase; phase III trial; Pilot Projects; Positioning Attribute; programs; Provider; Quality of life; Randomized Controlled Trials; real time monitoring; Recommendation; Regimen; Reporting; Schedule; Self Efficacy; side effect; Site; smartphone Application; Societies; Solid; standard of care; Standardization; Structure; Surveys; symposium; Symptoms; System; Technology; Text Messaging; Time; tool; Transplant Recipients; Transplantation; Tuberculosis; Universities; usability

Outcomes following solid organ transplantation (SOT) are generally excellent with 5-year survival exceeding 85% for most graft types and age groups. Immunosuppression nonadherence is an important factor leading to graft failure and patient mortality in SOT recipients since individuals are required to make a lifelong commitment to a strict medication schedule. Nonadherence has been reported to range from 15 to 40% among liver patients and more than 30% among kidney patients. Mobile applications (“apps”) provide a low-cost and scalable opportunity to improve medication adherence through more consistent monitoring, earlier detection of nonadherence, and frequent patient-provider communication with nonadherent patients. We have developed a patient-facing mHealth app, mDOT for Transplantation, that enables patients to view their immunosuppression regimen, record themselves taking doses of their medication, track and visualize progress on their own and with their transplant coordinator, document symptoms and side effects, and access educational content. There is a transplant provider web- based platform where they can review patient submitted videos, provide feedback about accepting the video as evidence of adherence, and receive notifications when patients report symptoms. The proposed project seeks to optimize this tool to increase medication adherence in transplant recipients. The aims of the project are: 1) to enhance mDOT for Transplantation with 2-way patient-provider communication/messaging capabilities and standardized text messages to promote behavior change and 2) to perform a pilot randomized controlled trial of mDOT for Transplantation compared to standard-of-care in SOT patients.

Public Health Relevance Statement:
Project Narrative Immunosuppression nonadherence is a leading cause of rejection, de novo DSA, graft loss, and death among kidney and liver transplant recipients. 30-80% of kidney and liver transplant recipients are nonadherent to their immunosuppression medications. We have developed a patient-facing mHealth app that enables patients to view their immunosuppression regimen, record themselves taking doses of their medication, track and visualize progress on their own and with their transplant coordinator, document symptoms and side effects, and access educational content. The goal of this project is to 1) optimize this system with two-way communication capacity in order to foster greater patient-provider engagement and 2) conduct a randomized controlled trial to compare medication adherence between app users and standard-of-care patients.

Project Terms:
Acute; Address; Adherence; adherence rate; age group; American; behavior change; Behavioral; Birds; Car Phone; Caregivers; Case Management; Cessation of life; Chronic Disease; Clinical; Communication; Communities; Consensus; cost; Custom; Data; design; Development; Directly Observed Therapy; Dose; Early Diagnosis; effectiveness implementation study; efficacy study; Ensure; Evaluation; Feedback; Fostering; Funding; Goals; graft failure; Guidelines; Health Personnel; Health Technology; Hepatitis C virus; Hospitalization; Immunosuppression; Immunosuppressive Agents; improved; Incentives; indexing; Individual; infectious disease treatment; Infrastructure; innovation; Intervention; Interview; Kidney; Kidney Transplantation; Liver; liver transplantation; medication compliance; medication nonadherence; mHealth; mobile application; Mobile Health Application; Monitor; mortality; Motivation; National Institute of Diabetes and Digestive and Kidney Diseases; Notification; Online Systems; Organ Transplantation; Outcome; Participant; Patient Care; Patient Noncompliance; patient oriented; Patient Self-Report; patient-clinician communication; Patients; Persuasive Communication; Pharmaceutical Preparations; Phase; phase III trial; Pilot Projects; Positioning Attribute; programs; Provider; Quality of life; Randomized Controlled Trials; real time monitoring; Recommendation; Regimen; Reporting; Schedule; Self Efficacy; side effect; Site; smartphone Application; Societies; Solid; standard of care; Standardization; Structure; Surveys; symposium; Symptoms; System; Technology; Text Messaging; Time; tool; Transplant Recipients; Transplantation; Tuberculosis; Universities; usability