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

February 15, 2022 updated by: Duke University

Next Generation Self Management: The Integration of a Mobile App Platform With Biomarkers in Kidney Transplantation

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional Group
An app for tracking medications, receiving personal coaching and educational material
Other: Smartphone App
An app for monitoring medications, blood pressure, exercise, healthy eating
Behavioral: Tailored education
in-person coaching
Active Comparator: Control Group
An app for tracking medications
Other: Smartphone App
An app for monitoring medications, blood pressure, exercise, healthy eating

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient activation scores as measured by Patient Activation Measure
Time Frame: baseline, 3 months, 6 months
0-100 scale that segments patients into one of four activation levels
baseline, 3 months, 6 months
Change in self-management as measured by Partners In Health survey
Time Frame: baseline, 3 months, 6 months
baseline, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Medication adherence as measured by self-tracking
Time Frame: up to 6 months
up to 6 months
Medication adherence as measured by blood levels
Time Frame: up to 6 months
up to 6 months
Presence of cell-free DNA
Time Frame: up to 6 months
up to 6 months
Presence of donor-specific antibodies
Time Frame: up to 6 months
up to 6 months
Allograft function as measured by urine protein/creatinine ratio
Time Frame: up to 6 months
up to 6 months
Allograft function as measured by serum creatinine
Time Frame: up to 6 months
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

CareDx

Investigators

  • Principal Investigator: Eileen Chambers, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2020

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

May 5, 2020

First Submitted That Met QC Criteria

May 7, 2020

First Posted (Actual)

May 11, 2020

Study Record Updates

Last Update Posted (Actual)

February 17, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00104469

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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