Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients: Enhancing Technological Innovation and Strengthening the Role of Small Businesses in Meeting Needs of Adolescent Organ Transplant
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Florida
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- Medication adherence based on medication level variability index
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
eMocha intervention
Adolescent patients randomized to the use of asynchronous mobile video directly observed therapy (DOT) intervention (eMocha DOT app)
Intervention: DOT intervention (Other)
Standard of care
Adolescent patients who continue enhanced goal-setting standard of care
Outcomes
Primary Outcomes
Medication adherence based on medication level variability index
Time Frame: 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
Time Frame: 1 weeks
Number of doses observed and reviewed by nursing staff compare to number of prescribed doses per day
Hospitalization
Time Frame: 6 months post-intervention
Number of hospitalizations
Patient Activation Measure
Time Frame: 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
Engagement metrics
Time Frame: 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)
Time Frame: Pretest at enrollment and posttest at 12 weeks
HRQOL
Adolescent Medication Barriers Scale (AMBS)
Time Frame: Pretest, posttest
To assess adolescent perceived barriers to medication adherence
Parent Medication Barriers Scale (PMBS)
Time Frame: Pretest at enrollment and posttest at 12 weeks
To assess parental perceived barriers to their child taking their medication
Late Acute Rejection
Time Frame: 6 months post-intervention
Number of biopsy-proven rejection, clinician-assigned rejection
Patient Assessment of Chronic Illness Care (PACIC)
Time Frame: 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
Time Frame: Pretest at enrollment and posttest at 12 weeks
Collected using a modified version of the engagement index questionnaire used
Secondary Outcomes
No secondary outcomes reported