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

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Duke University

Status

Completed

Conditions

Medication Compliance

Treatments

Behavioral: Tailored education
Other: Smartphone App

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

22 participants in 2 patient groups

Interventional Group
Experimental group
Description:
An app for tracking medications, receiving personal coaching and educational material
Treatment:
Other: Smartphone App
Behavioral: Tailored education
Control Group
Active Comparator group
Description:
An app for tracking medications
Treatment:
Other: Smartphone App

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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