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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
| University of Pittsburgh | OTHER |
| The Emmes Company, LLC |
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The specific aim is to pilot-test our developed intervention manual's ability to improve patients' adherence to medications and medical outcomes (rejection rate, liver enzyme levels) in participating centers.
Nonadherence (not taking the medications as prescribed) is the most common cause of late acute rejection in children who have had a liver transplant, and thus is associated with graft loss, increased expenditures on care, and ultimately death. Researchers in this application developed a biomarker to identify nonadherence, calculating the standard deviation (SD) of consecutive immunosuppressant blood levels for each patient to capture the degree of variability between individual levels (higher SD = less consistent levels). By applying a threshold, this marker identifies nonadherent patients. A consortium of transplant centers is currently testing this marker through the MALT (Medication Adherence in children who had a Liver Transplant) study. MALT investigators now propose to take advantage of this existing collaboration to pilot-test an intervention to improve adherence in patients who are identified by this marker.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemetric | Experimental | Enrolled patients will be followed for 12 months during which they will receive the study telemetry intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemetric | Behavioral | A manualized behavioral management approach focusing on avoidance and addressing barriers to adherence, delivered via telephone or internet chat applications. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Adherence | Change in Adherence at one year compared to at baseline measured via the Standard Deviation of Tacrolimus levels obtained | at baseline and one year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Incidence of rejection | Change in Incidence of rejection compared at one year to baseline | at baseline and at one year |
| Liver Enzyme Levels | at baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eyal Shemesh, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Mattell Children's Hospital | Los Angeles | California | 90095 | United States | ||
| Cincinnati Children's Hospital Medical Center |
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| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| INDUSTRY |
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| Liver Enzyme Levels | at one year |
| Feasibility | Participation in the intervention (receive all of the remote interactions called for in the manual, presented as a percentage of received / offered during the intervention active phase, 1 year) | at one year |
| Cincinnati |
| Ohio |
| 45229 |
| United States |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |