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

NCT ID: NCT04382248

Last Updated: 2022-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2021-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Medication Compliance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Interventional Group

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

Group Type EXPERIMENTAL

Smartphone App

Intervention Type OTHER

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

Tailored education

Intervention Type BEHAVIORAL

in-person coaching

Control Group

An app for tracking medications

Group Type ACTIVE_COMPARATOR

Smartphone App

Intervention Type OTHER

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

Interventions

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Smartphone App

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

Intervention Type OTHER

Tailored education

in-person coaching

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CareDx

INDUSTRY

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eileen Chambers, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00104469

Identifier Type: -

Identifier Source: org_study_id

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