Technology Enabled And Molecular Monitoring of the Allograft and Transplant rEcipient

Stopped early

Conditions studied: Transplant

In brief

The primary objective of the study is to assess the impact of AlloCare mHealth remote monitoring on the early post-transplant period in solid organ transplantation.The outcome measure for primary objective is overall reduction in Readmission Rate to hospital in 90 days for all causes. Patients will be assessed across 4 different organ groups (Kidney, Liver, Lung and Heart Transplantation). The secondary objective is to consider the impact of mHealth and app-based monitoring on variables known to impact long term outcomes over the first 12 months post transplantation, as well as impact on quality of life. The outcome measures for secondary objective are: 1. Tacrolimus Variability (Time in Therapeutic Range,) as a surrogate to adherence and compliance 2. BPAR within 3,6, and 12 months 3. Patient satisfaction at 90 days 4. SF-36 change at 90 days 5. HbA1c monitoring (diabetic patients only)

Key facts

Study ID

NCT05033548

Run by

CareDx

People needed

246

Starts

2021-10-26

Expected to finish

2023-07-31

Last updated by the study team

2023-08-30

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 12 years or above. (Gillick Competent)

You may not qualify if…

• The participant may not enter the trial if ANY of the following apply:
• Participant who is pregnant, lactating or planning pregnancy during the trial.
• Significant hepatic impairment (determined by the PI)
• Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
• Participant with life expectancy of less than 6 months, or inappropriate for diagnostic monitoring through regular blood sampling.
• >3 months post-transplant
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
• Participants who have participated in another research trial involving an investigational pharmaceutical product in the past 12 weeks.
• Multi-organ transplant (e.g., Kidney-Pancreas).
• Recipients of a transplant from a monozygotic (identical) twin
• Recipient of non-autologous bone marrow transplant
• Patients with a history of needle phobia.
• Patients who are not English or Spanish speaking

Where it is running

• University of Alabama Birmingham — Birmingham, Alabama, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Kentucky — Lexington, Kentucky, United States
• ECMC State University of NY/University of Buffalo — Buffalo, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Tennessee — Memphis, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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