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

Not Applicable

Completed

• Conditions: Medication Compliance

• Registration Number: NCT04382248
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-07
• Study First Posted: 2020-05-11
• Study Start: 2020-10-15
• Primary Completion: 2021-08-31
• Study Completion: 2021-11-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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
Change in self-management as measured by Partners In Health survey	baseline, 3 months, 6 months

Secondary Outcome Measures

Name	Time	Method
Medication adherence as measured by self-tracking	up to 6 months
Medication adherence as measured by blood levels	up to 6 months
Presence of cell-free DNA	up to 6 months
Presence of donor-specific antibodies	up to 6 months
Allograft function as measured by urine protein/creatinine ratio	up to 6 months
Allograft function as measured by serum creatinine	up to 6 months

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States