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

Not Applicable

Completed

• Conditions: Medication Compliance
• Interventions: Other: Smartphone App; Behavioral: Tailored education

• 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Smartphone App	An app for tracking medications
Interventional Group	Smartphone App	An app for tracking medications, receiving personal coaching and educational material
Interventional Group	Tailored education	An app for tracking medications, receiving personal coaching and educational material

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