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OpenTrials
Completed

NCT Number: NCT04382248

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.

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Key information

Conditions

Medication Compliance Behavior Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

12 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smartphone app

Other

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

Tailored education

Behavioral

in-person coaching

Primary outcomes

  1. 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

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

    Time frame: baseline, 3 months, 6 months

Secondary outcomes

  1. Medication adherence as measured by self-tracking

    Time frame: up to 6 months

  2. Medication adherence as measured by blood levels

    Time frame: up to 6 months

  3. Presence of cell-free DNA

    Time frame: up to 6 months

  4. Presence of donor-specific antibodies

    Time frame: up to 6 months

  5. Allograft function as measured by urine protein/creatinine ratio

    Time frame: up to 6 months

  6. Allograft function as measured by serum creatinine

    Time frame: up to 6 months

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • CareDx

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 11, 2020
Registry last updated
Feb 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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