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

Medication Compliance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04382248
• Other study ID #: Pro00104469
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Medication Compliance

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