간 이식을 받은 청소년의 약물 순응도 개선 (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).
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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Los Angeles, California, 미국, 90027
- Children's Hospital Los Angeles
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Los Angeles, California, 미국, 90095
- Mattel Children's Hospital UCLA
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San Francisco, California, 미국, 94107
- Benioff Children's Hospital UCSF
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Florida
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Miami, Florida, 미국, 33136
- Miami Transplant Institute
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Georgia
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Atlanta, Georgia, 미국, 30322
- Children's Healthcare of Atlanta/Emory
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Illinois
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Chicago, Illinois, 미국, 60611
- Lurie Children's Hospital
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- C.S.Mott Children's Hospital
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New York
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New York, New York, 미국, 10032
- Columbia University Medical Center
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New York, New York, 미국, 10029
- Icahn School of Medicine at Mount Sinai
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, 미국, 15224
- Children's Hospital of Pittsburgh
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Texas
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Houston, Texas, 미국, 77030
- Texas Children's Hospital
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Ontario
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Toronto, Ontario, 캐나다, M5G1X8
- The Hospital For Sick Children Toronto
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
|
간섭 없음: Standard of Care Arm
Adolescent with MLVI>2 to receive standard of care. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants Experiencing at Least One Episode of Rejection
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The Standard Deviation of A Series Of Tacrolimus Levels (MLVI)
기간: 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
기간: 2 Years
|
Number of Participants with Locally and Centrally Determined Rejection Biopsy Proven Rejection |
2 Years
|
|
Number of Locally Determined Rejections by Biopsy Per Patient During Follow-up
기간: 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
|
|
Time to First Locally Rejection From Enrollment
기간: about 12 months
|
Time to first locally determined rejection by biopsy from enrollment |
about 12 months
|
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Time to First Centrally Determined Rejection
기간: 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
기간: 2 Years
|
Number of deaths |
2 Years
|
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Occurrence of Re-Listing For Transplantation
기간: 2 Years
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Number of participants listing for retransplantation |
2 Years
|
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Number of Participants With ALT >150 U/L
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Eyal Shemesh, MD, Icahn School of Medicine at Mount Sinai
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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