Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R44HL167591-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| emocha Mobile Health, Inc. | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eMocha intervention | Experimental | Adolescent patients randomized to the use of asynchronous mobile video directly observed therapy (DOT) intervention (eMocha DOT app) |
|
| Standard of care | No Intervention | Adolescent patients who continue enhanced goal-setting standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DOT intervention | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Medication adherence based on medication level variability index | 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. | 12 weeks |
| Directly observed medication adherence | Number of doses observed and reviewed by nursing staff compare to number of prescribed doses per day | 1 weeks |
| Late Acute Rejection | Number of biopsy-proven rejection, clinician-assigned rejection | 6 months post-intervention |
| Hospitalization | Number of hospitalizations | 6 months post-intervention |
| Patient Activation Measure | A 13-item scale designed to measure a patient's perception of their knowledge, skill and confidence in managing their chronic health condition | Pretest at enrollment and posttest at 12 weeks |
| Patient Assessment of Chronic Illness Care (PACIC) | 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. | Pretest at enrollment and posttest at 12 weeks |
| Self-reported user satisfaction with the DOT app |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
• Those with cognitive impairments will not be eligible for enrollment due to inability to provide informed assent
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dipankar Gupta, MD | Contact | 352-273-5422 | dgupta@ufl.edu | |
| Dalia Lopez-Colon, PhD | Contact | 352-281-6723 | dalylc@ufl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Dipankar Gupta, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami, Miller School of Medicine | Recruiting | Coral Gables | Florida | 33146 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Collected using a modified version of the engagement index questionnaire used
| Pretest at enrollment and posttest at 12 weeks |
| Engagement metrics | Standard engagement metrics or paradata (e.g., amount, frequency, duration, and depth of use) | Pretest at enrollment and posttest at 12 weeks |
| PedsQL 3.0 Transplant Module (PedsQL-TM) | HRQOL | Pretest at enrollment and posttest at 12 weeks |
| Adolescent Medication Barriers Scale (AMBS) | To assess adolescent perceived barriers to medication adherence | Pretest, posttest |
| Parent Medication Barriers Scale (PMBS) | To assess parental perceived barriers to their child taking their medication | Pretest at enrollment and posttest at 12 weeks |
| University of Florida | Recruiting | Gainesville | Florida | 32610 | United States |
|
| Joe DiMaggio Children's Hospital | Recruiting | Hollywood | Florida | 33021 | United States |
|
| FSU College of Medicine | Not yet recruiting | Tallahassee | Florida | 32306 | United States |
|
| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| D015438 | Health Behavior |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D001519 | Behavior |
Not provided
Not provided