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Technology Enabled And Molecular Monitoring of the Allograft and Transplant rEcipient

NCT05033548 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 246

Last updated 2023-08-30

No results posted yet for this study

Summary

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)

Conditions

  • Transplant

Sponsors & Collaborators

  • CareDx

    lead INDUSTRY

Principal Investigators

  • Shimul Shah, M.D. · University of Cincinnati

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-26
Primary Completion
2023-02-02
Completion
2023-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05033548 on ClinicalTrials.gov