Medication Compliance
Conditions
Keywords
kidney transplant, teens, mobile app
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.
Interventions
OTHERSmartphone App
An app for monitoring medications, blood pressure, exercise, healthy eating
BEHAVIORALTailored education
in-person coaching
Sponsors
CareDx
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
12 Years to 40 Years
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Presence of cell-free DNA | up to 6 months |
| Presence of donor-specific antibodies | up to 6 months |
| Medication adherence as measured by self-tracking | up to 6 months |
| Allograft function as measured by serum creatinine | up to 6 months |
| Allograft function as measured by urine protein/creatinine ratio | up to 6 months |
| Medication adherence as measured by blood levels | up to 6 months |
Countries
United States
Outcome results
None listed