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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04382248
Other study ID # Pro00104469
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2020
Est. completion date November 30, 2021

Study information

Verified date February 2022
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date November 30, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers No
Gender All
Age group 12 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Smartphone App
An app for monitoring medications, blood pressure, exercise, healthy eating
Behavioral:
Tailored education
in-person coaching

Locations

Country Name City State
United States Duke University Durham North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Duke University CareDx

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in patient activation scores as measured by Patient Activation Measure 0-100 scale that segments patients into one of four activation levels baseline, 3 months, 6 months
Primary Change in self-management as measured by Partners In Health survey baseline, 3 months, 6 months
Secondary Medication adherence as measured by self-tracking up to 6 months
Secondary Medication adherence as measured by blood levels up to 6 months
Secondary Presence of cell-free DNA up to 6 months
Secondary Presence of donor-specific antibodies up to 6 months
Secondary Allograft function as measured by urine protein/creatinine ratio up to 6 months
Secondary Allograft function as measured by serum creatinine up to 6 months
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