The Integration of a Mobile App Platform With Biomarkers in Kidney Transplantation

Duke University

Status: Completed

Conditions: Medication Compliance

Treatments: Other: Smartphone App; Behavioral: Tailored education

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04382248

Pro00104469

Details and patient eligibility

About

The purpose of this study is to examine the feasibility and acceptability of a mobile app to improve self-management skills and medication adherence in kidney transplantation, to assess the clinical benefit of mobile app in combination with tailored coaching using text messaging to enhance patient activation, self-management and medication adherence and to determine whether immunological biomarkers such as cell-free DNA and donor specific antibodies are associated with self-management and medication adherence.

Enrollment: 22 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. age 12-40 kidney transplant recipients with stable kidney function at least one month from the time of transplantation
• 2. have and use a smartphone
• 3. patients without pre-formed antibodies

Exclusion criteria

• 1. Patients <12 or >40
• 2. patient with pre-existing antibodies
• 3. patients with rejection at the time of enrollment
• 4. patients without a smartphone
• 5. patients with developmental delay or psychological impairment and unable to use an app

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

Interventional Group

Experimental group

Description:

An app for tracking medications, receiving personal coaching and educational material

Treatment:

Behavioral: Tailored education

Other: Smartphone App

Control Group

Active Comparator group

Description:

An app for tracking medications

Treatment:

Other: Smartphone App