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

Duke University22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Medication Compliance

Interventions

Smartphone AppOTHER

An app for monitoring medications, blood pressure, exercise, healthy eating

Tailored educationBEHAVIORAL

in-person coaching

Eligibility

Sex: ALLMin age: 12 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Duke University

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Change in patient activation scores as measured by Patient Activation Measure

0-100 scale that segments patients into one of four activation levels

Time frame: baseline, 3 months, 6 months

Change in self-management as measured by Partners In Health survey

Time frame: baseline, 3 months, 6 months

Secondary Outcomes

Medication adherence as measured by self-tracking

Time frame: up to 6 months

Medication adherence as measured by blood levels

Time frame: up to 6 months

Presence of cell-free DNA

Time frame: up to 6 months

Presence of donor-specific antibodies

Time frame: up to 6 months

Allograft function as measured by urine protein/creatinine ratio

Time frame: up to 6 months

Allograft function as measured by serum creatinine

Time frame: up to 6 months

Data from ClinicalTrials.gov

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