Poprawa przestrzegania zaleceń lekarskich u młodzieży po przeszczepie wątroby (iMALT)
The study's aim is to test a tailored telemetric intervention to reduce rejection incidence by improving medication adherence in a group of adolescent liver transplant recipients identified as nonadherent by a marker (the Medication Level Variability Index, MLVI).
Przegląd badań
Szczegółowy opis
This is a prospective, multi-center, randomized controlled trial. The study will be conducted in transplant centers in the United States and Canada. Estimated final sample size of 140 after attrition. Pediatric adolescent and young adult (age at enrollment ≥12 and < 20) transplant recipients will be eligible for participation in the study. Eligible participants will be randomly assigned to intervention or control group. An interim analysis to evaluate efficacy will be performed. Missing data will not be imputed for secondary analyses.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Ontario
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Toronto, Ontario, Kanada, M5G1X8
- The Hospital For Sick Children Toronto
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California
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Los Angeles, California, Stany Zjednoczone, 90027
- Children's Hospital Los Angeles
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Los Angeles, California, Stany Zjednoczone, 90095
- Mattel Children's Hospital UCLA
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San Francisco, California, Stany Zjednoczone, 94107
- Benioff Children's Hospital UCSF
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Florida
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Miami, Florida, Stany Zjednoczone, 33136
- Miami Transplant Institute
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Georgia
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Atlanta, Georgia, Stany Zjednoczone, 30322
- Children's Healthcare of Atlanta/Emory
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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60611
- Lurie Children's Hospital
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Michigan
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Ann Arbor, Michigan, Stany Zjednoczone, 48109
- C.S.Mott Children's Hospital
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New York
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New York, New York, Stany Zjednoczone, 10032
- Columbia University Medical Center
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New York, New York, Stany Zjednoczone, 10029
- Icahn School of Medicine at Mount Sinai
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Pennsylvania
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15224
- Children's Hospital of Pittsburgh
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Texas
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Houston, Texas, Stany Zjednoczone, 77030
- Texas Children's Hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- The patient is ≥ 12 and < 20 years of age at enrollment.
- ≥2.5 years after last liver transplantation.
- Guardian's consent, adolescent assent at enrollment.
- The patient is prescribed tacrolimus.
- The patient's MLVI (SD of tacrolimus) was > 2 when calculated by the site for a period of 2 years prior to the review date
Exclusion Criteria:
- The patient has had transplant of an organ other than liver.
- The patient is currently listed for any organ transplantation.
- The patient is expected to transition to another service (e.g., adult clinic, another
- hospital) during the two years of the study.
- Pregnant patients.
- A temporary exclusion: the patient is not medically stable or was hospitalized for >48 consecutive hours in the past three months.
- Site PI, study PI, or Medical Monitor determines that the patient should not be a candidate for the intervention due to factors that are not covered in the above criteria.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Telemetric Intervention Arm
Adolescent with MLVI>2 to receive the telemetric intervention. |
Calls, scripted by a manual; the frequency of the calls varies with patient's MLVI status and preferences. |
|
Brak interwencji: Standard of Care Arm
Adolescent with MLVI>2 to receive standard of care. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of Participants Experiencing at Least One Episode of Rejection
Ramy czasowe: 2 Years
|
The incidence of biopsy-proven acute cellular rejection (number of patients experiencing at least one episode of rejection) at any time during the 2 years of follow up. Biopsy-confirmed late acute rejection, as determined by the majority of 3 masked readings of liver biopsy images by 3 pathologists that are not from the clinical site at which the patient is treated. Patients with incomplete follow-up (for example due to death, re-transplant, listing for re-transplantation), was assumed to have experienced a rejection for the purpose of the primary analysis. |
2 Years
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
The Standard Deviation of A Series Of Tacrolimus Levels (MLVI)
Ramy czasowe: 2 Years
|
Medication level variability index (MLVI) score is defined as the Standard Deviation (SD) Of Tacrolimus Blood Levels over time during follow-up. MLVI identifies medication-taking behavior. A higher SD indicates less consistent adherence. |
2 Years
|
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Number of Participants With Locally and Centrally Determined Rejection by Biopsy
Ramy czasowe: 2 Years
|
Number of Participants with Locally and Centrally Determined Rejection Biopsy Proven Rejection |
2 Years
|
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Number of Locally Determined Rejections by Biopsy Per Patient During Follow-up
Ramy czasowe: 2 Years
|
Rate Of Locally Determined Biopsy Proven Rejection determined by Number of locally determined rejections by biopsy per patient during follow-up |
2 Years
|
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Time to First Locally Rejection From Enrollment
Ramy czasowe: about 12 months
|
Time to first locally determined rejection by biopsy from enrollment |
about 12 months
|
|
Time to First Centrally Determined Rejection
Ramy czasowe: up to 12 months
|
Time, in months, to first centrally determined rejection by biopsy from enrollment |
up to 12 months
|
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Occurrence of Death
Ramy czasowe: 2 Years
|
Number of deaths |
2 Years
|
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Occurrence of Re-Listing For Transplantation
Ramy czasowe: 2 Years
|
Number of participants listing for retransplantation |
2 Years
|
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Number of Participants With ALT >150 U/L
Ramy czasowe: 2 Years
|
Number of Participants achieving above the predetermined threshold alanine trans aminase (ALT) > 150 |
2 Years
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Mean and Maximal ALT Level
Ramy czasowe: 2 Years
|
mean and maximal ALT (defined as in MALT as the mean of all levels recorded during the study period and the maximal level recorded during the study period) |
2 Years
|
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Number of Participants Achieving Mean GGT > 150
Ramy czasowe: 2 Years
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Number of participants achieving mean number above threshold GGT > 150 Gamma Glutamyl Transferase (gGT) |
2 Years
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Mean and Maximal gGT
Ramy czasowe: 2 Years
|
mean and maximal gGT (defined as in MALT as the mean of all levels recorded during the study period and the maximal level recorded during the study period) |
2 Years
|
Współpracownicy i badacze
Współpracownicy
Śledczy
- Główny śledczy: Eyal Shemesh, MD, Icahn School of Medicine at Mount Sinai
Publikacje i pomocne linki
Publikacje ogólne
- Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
- Shemesh E, Anand R, Annunziato RA, Fredericks EM, Garcia J, Gupta NA, Kleinman LC, Kriegermeier A, Mysore KR, Ng VL, Lobritto SJ, Patel S, Perito ER, Rand EB, Romero R, Venick RS, Duncan-Park S, Mitchell J, Anderson SG, Stuber ML, Reyes-Mugica M, Mazariegos GV, Shneider BL. A remote intervention to improve medication nonadherence guided by a marker of risk derived from the electronic health records of adolescent transplant recipients. Am J Transplant. 2026 Sep;26(9):2099-2110. doi: 10.1016/j.ajt.2026.04.030. Epub 2026 May 27.
- Tutino R, Annunziato R, Dunphy C, Anand R, Mitchell J, Stuber M, Shemesh E, Duncan-Park S; for iMALT. Development of a Targeted, Telehealth Intervention: Experiences From the Improving Medication Adherence in Adolescents and Young Adults Following a Liver Transplantation (iMALT) Multisite Trial. Pediatr Transplant. 2025 Aug;29(5):e70109. doi: 10.1111/petr.70109.
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- GCO 18-0061
- U01DK119200 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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