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

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT04382248
Collaborator
CareDx (Industry)
22
Enrollment
1
Location
2
Arms
13.5
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Smartphone App
  • Behavioral: Tailored education
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Next Generation Self Management: The Integration of a Mobile App Platform With Biomarkers in Kidney Transplantation
Actual Study Start Date :
Oct 15, 2020
Actual Primary Completion Date :
Aug 31, 2021
Actual Study Completion Date :
Nov 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in patient activation scores as measured by Patient Activation Measure [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 [baseline, 3 months, 6 months]

Secondary Outcome Measures

  1. Medication adherence as measured by self-tracking [up to 6 months]

  2. Medication adherence as measured by blood levels [up to 6 months]

  3. Presence of cell-free DNA [up to 6 months]

  4. Presence of donor-specific antibodies [up to 6 months]

  5. Allograft function as measured by urine protein/creatinine ratio [up to 6 months]

  6. Allograft function as measured by serum creatinine [up to 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. age 12-40 kidney transplant recipients with stable kidney function at least one month from the time of transplantation
    1. have and use a smartphone
    1. patients without pre-formed antibodies
Exclusion Criteria:
    1. Patients <12 or >40
    1. patient with pre-existing antibodies
    1. patients with rejection at the time of enrollment
    1. patients without a smartphone
    1. patients with developmental delay or psychological impairment and unable to use an app

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Durham North Carolina United States 27710

Sponsors and Collaborators

  • Duke University
  • CareDx

Investigators

  • Principal Investigator: Eileen Chambers, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT04382248
Other Study ID Numbers:
  • Pro00104469
First Posted:
May 11, 2020
Last Update Posted:
Feb 17, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Duke University
kidney transplant
teens
mobile app

Study Results

No Results Posted as of Feb 17, 2022