Health Behavior, Heart Transplant Rejection, Immune Suppression, Medication Nonadherence, Patient Engagement, Pediatric Heart Transplant, Remote Monitoring
Conditions
Brief summary
We will conduct a two-group randomized controlled trial to examine the eMocha DOT intervention with pediatric HT recipients.In this population, medication nonadherence remains a primary cause of late acute rejection (LAR) episodes, increased number of hospitalizations, graft failure, and patient mortality. Herein, we propose an innovative approach to promote medication adherence and improve patient and graft outcomes.
Detailed description
Few interventions have proven to be successful in promoting medication adherence and impacting short- and long-term post-transplant outcomes in adolescent heart transplant (HT) recipients. Improving adherence is a persistent challenge with youth experiencing chronic health conditions, especially among adolescent transplant recipients. Adolescent organ transplant recipients experience unique challenges remaining adherent to the complex post-transplant regimen, with rates of non-adherence as high as 40% to 60%. In this population, medication non-adherence remains a primary cause of late acute rejection (LAR) episodes, increased number of hospitalizations, graft failure, and patient mortality. Herein, we propose an innovative approach to promote medication adherence and improve patient and graft outcomes.
Interventions
OTHERDOT intervention
A mobile health application developed by eMocha Health Inc. facilitates asynchronous mobile video directly observed therapy (DOT) intervention, empowering users to track dose-by-dose medication adherence
Sponsors
University of Florida
emocha Mobile Health, Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Eligible participants are 10-21 years of age * Have received a heart transplant and are followed participating pediatric heart transplant centers * English-speaking or Spanish-speaking * Own a smart-phone or have access to the mobile app through other devices * Are willing to receive information through it * Have a MLVI score of greater than 2.0 over the last year
Exclusion criteria
• Those with cognitive impairments will not be eligible for enrollment due to inability to provide informed assent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication adherence based on medication level variability index | 12 weeks | medication level variability index (MLVI). MLVI is calculated as the Standard Deviation of a set of at least 3 tacrolimus trough blood levels for each participant. |
| Directly observed medication adherence | 1 weeks | Number of doses observed and reviewed by nursing staff compare to number of prescribed doses per day |
| Late Acute Rejection | 6 months post-intervention | Number of biopsy-proven rejection, clinician-assigned rejection |
| Hospitalization | 6 months post-intervention | Number of hospitalizations |
| Patient Activation Measure | Pretest at enrollment and posttest at 12 weeks | A 13-item scale designed to measure a patient's perception of their knowledge, skill and confidence in managing their chronic health condition |
| Patient Assessment of Chronic Illness Care (PACIC) | Pretest at enrollment and posttest at 12 weeks | A 20-item scale with five subscales (scale of 1 (none) to 5 (always), total score 20 to 200, higher score being better outcome) that assess patient activation, delivery system design, goal setting, problem-solving and contextual counseling, and follow-up and coordination. |
| Self-reported user satisfaction with the DOT app | Pretest at enrollment and posttest at 12 weeks | Collected using a modified version of the engagement index questionnaire used |
| Engagement metrics | Pretest at enrollment and posttest at 12 weeks | Standard engagement metrics or paradata (e.g., amount, frequency, duration, and depth of use) |
| PedsQL 3.0 Transplant Module (PedsQL-TM) | Pretest at enrollment and posttest at 12 weeks | HRQOL |
| Adolescent Medication Barriers Scale (AMBS) | Pretest, posttest | To assess adolescent perceived barriers to medication adherence |
| Parent Medication Barriers Scale (PMBS) | Pretest at enrollment and posttest at 12 weeks | To assess parental perceived barriers to their child taking their medication |
Countries
United States
Contacts
CONTACTDipankar Gupta, MD
CONTACTDalia Lopez-Colon, PhD
PRINCIPAL_INVESTIGATORDipankar Gupta, MD
University of Florida
Outcome results
None listed