mHealth Medication Safety Intervention

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Medication Compliance

Treatments: Other: Pharmacist-led medication therapy using mHealth application

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03247322

Pro00068746

Details and patient eligibility

About

TRANSAFE Rx is a 12-month, parallel two-arm, 1:1 randomized controlled clinical trial, involving 136 participants (68 in each arm) measuring the clinical and economic effectiveness of a pharmacist-led intervention, which utilizes an innovative mHealth application to improve medication safety and health outcomes, as compared to usual post-transplant care. The primary goal of the TRANSAFE Rx study is to demonstrate significant reductions in med safety issues leading to reduced healthcare resource utilization in kidney transplantation through a pharmacist-led, mHealth-enabled, intervention. This study will provide detailed and novel information on the incidence, etiologies and outcomes of med errors and adverse drug events in this high-risk population; while also demonstrating the effectiveness of this intervention on reducing the incidence and impact of med safety issues in kidney transplantation.

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Kidney transplant recipient between 6 and 36 months post-transplant
• At least 18 years of age
• Transplant MD agrees that patient is eligible to participate

Exclusion criteria

• Multi-organ recipient
• Patient is incapable of:
• Measuring their own blood pressure and glucose (if applicable)
• Self-administering medications
• Speaking, hearing and reading English
• Utilizing the mHealth application, after training

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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136 participants in 2 patient groups

mHealth Group

Experimental group

Description:

Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).

Treatment:

Other: Pharmacist-led medication therapy using mHealth application

Usual Care Group

No Intervention group

Description:

Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.