The Integration of a Mobile App Platform With Biomarkers in Kidney Transplantation
Next Generation Self Management: The Integration of a Mobile App Platform With Biomarkers in Kidney Transplantation
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2020
CompletedFirst Posted
Study publicly available on registry
May 11, 2020
CompletedStudy Start
First participant enrolled
October 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2021
CompletedFebruary 17, 2022
February 1, 2022
11 months
May 5, 2020
February 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
Interventional Group
EXPERIMENTALAn app for tracking medications, receiving personal coaching and educational material
Control Group
ACTIVE COMPARATORAn app for tracking medications
Interventions
An app for monitoring medications, blood pressure, exercise, healthy eating
Eligibility Criteria
You may qualify if:
- \) age 12-40 kidney transplant recipients with stable kidney function at least one month from the time of transplantation
- \) have and use a smartphone
- \) patients without pre-formed antibodies
You may not qualify if:
- \) Patients \<12 or \>40
- \) patient with pre-existing antibodies
- \) patients with rejection at the time of enrollment
- \) patients without a smartphone
- \) patients with developmental delay or psychological impairment and unable to use an app
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- CareDxcollaborator
Study Sites (1)
Duke University
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eileen Chambers, MD
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2020
First Posted
May 11, 2020
Study Start
October 15, 2020
Primary Completion
August 31, 2021
Study Completion
November 30, 2021
Last Updated
February 17, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share