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

Study Overview
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Brief Summary
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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.

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

Conditions
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Medication Compliance

Intervention / Treatment
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* Other: Smartphone App
* Behavioral: Tailored education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional Group<br>An app for tracking medications, receiving personal coaching and educational material | Other: Smartphone App<br>* An app for monitoring medications, blood pressure, exercise, healthy eating<br>Behavioral: Tailored education<br>* in-person coaching<br>|
| Active Comparator: Control Group<br>An app for tracking medications | Other: Smartphone App<br>* An app for monitoring medications, blood pressure, exercise, healthy eating<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change in self-management as measured by Partners In Health survey |  | baseline, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney transplant, teens, mobile app