Technology Enabled And Molecular Monitoring of the Allograft and Transplant rEcipient

NCT05033548 | Terminated

• 1 other identifier: SN-C-00018
• Study Type: observational
• Target: 246
• Locations: 1 country
• Sites: 10

Brief 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

Outcome Measures

Primary Outcomes (1)

• Overall reduction in Readmission Rate to hospital within 90 days (all causes)

  The aim of this study is to evaluate AlloCare and remote patient monitoring developed as an integrated mHealth service, assessing whether the combination of app and monitoring deployed within the solid organ transplant population can help support durable behavioral changes in patients that improve self-care and shared decision-making within the patient-provider relationship.

  90 days

Secondary Outcomes (5)

• Tacrolimus Variability (Time in Therapeutic Range,) at 3,6, and 12 months as a surrogate to adherence and compliance

  3, 6, and 12 months

• BPAR at 3, 6, and 12 months

  3, 6, and 12 months

• Patient satisfaction at 90 days

  90 days

• SF-36 change at 90 days

  90 days

• HbA1c monitoring (diabetic patients only) at 3,6, and 12 months

  3, 6, and 12 months

Study Arms (2)

Managed with AlloCare Monitoring

Managed with Standard of Care

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with a single solid organ transplant of either Lung, Liver, Kidney or Heart, will be invited to participate.

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

Sponsors & Collaborators

• CareDx: lead

Study Sites (10)

University of Alabama Birmingham

Birmingham, Alabama, 35233, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

ECMC State University of NY/University of Buffalo

Buffalo, New York, 14215, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Tennessee

Memphis, Tennessee, 38104, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Study Officials

• Shimul Shah, M.D.

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 5, 2021
• Study Start: October 26, 2021
• Primary Completion: February 2, 2023
• Study Completion: July 31, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-06

Locations

US (10)