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Technology Enabled And Molecular Monitoring of the Allograft and Transplant rEcipient (TEAMMATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05033548
Recruitment Status : Recruiting
First Posted : September 5, 2021
Last Update Posted : July 19, 2022
Sponsor:
Information provided by (Responsible Party):
CareDx

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)

Condition or disease
Transplant

Detailed Description:

If a patient is randomized to the AlloCare App arm and does not have access to a smartphone to utilize AlloCare App, a device will be provided for the duration of the study for use, with the AlloCare app installed. Otherwise, patients will be allowed to use their own device . The device and data plan will be covered by the sponsor for the duration of the study. Enrollment on the Allocare app with weekly transmission of patient data to the transplant programs is expected. In addition, all patients will have AlloSure dd-cfDNA surveillance per their institutional schedule. These patients will be compared to the current standard: Paper binder, with written diary, also including AlloSure with weekly visits as needed per center protocol.

Patients will follow an AlloSure cfDNA testing schedule based on medical necessity and outlined as the standard of care by the institution. The mHealth remote monitoring is weekly for the first 90 days and then monthly until 12 months post-transplant. The remainder of the schedule will follow the current standard of care.

If study sites are unable to follow this recommend schedule, please create an amended schedule of events for review by the sponsor. DSA (optional) is aimed to be collected as part of their post-transplant surveillance. The EMR will be examined at 3,6, and 12 months post transplantation.

The AlloCare App is a smart phone-based app that empowers transplant patients to manage their health by enabling them to adhere to and track their health activities and transmit data on their compliance to their care team & community providers. Primary functionality of the application involves medication management, which includes up to date medication lists derived directly from the EHR, scheduling of medication and medication reminders and adherence tracking. In addition, the user can record and monitor other wellness activities such as water intake, steps, mood, sleep etc. Support for testing adherence is provided by allowing the user to connect to patient care managers directly through the app, schedule both in-center and mobile blood-draws and providing lab visit reminders. Lastly, the app provides the user with support through multi-modality educational materials and a virtual connection to a community of other post-transplant patients, as well as to their own care givers.

Patients will also be offered mobile phlebotomy if they are unable to visit a local lab. This is a service provided by CareDx for all patients needing Allosure test for clinical decision making. The mobile blood draw will be ordered by your providers as clinically necessary and coordinated by CareDx, which will draw all regular tests, urine sample as well as the AlloSure. Results are couriered to your lab of choice for analysis. This can be your own hospital lab so you can directly see the results in your hospital EMR. AlloSure results will be sent to the center in the same format as you are currently receiving them. Patients utilizing AlloCare App for post-transplant monitoring will be able to review their Allosure results on the App.

For investigators who do not have an electronic medical record (EMR) with transplant functionality and/or a fully functional transplant management database, the OTTR SaaS platform is an option that can be provided for the duration of the investigation, to allow capture of all critical data fields. OTTR SaaS is a fully HIPAA compliant Transplant patient management application with pre- and post-transplant longitudinal workflow management and data capture capabilities.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 4000 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 12 Months
Official Title: Technology Enabled And Molecular Monitoring of the Allograft and Transplant rEcipient
Actual Study Start Date : October 26, 2021
Estimated Primary Completion Date : October 10, 2024
Estimated Study Completion Date : October 10, 2024

Group/Cohort
Managed with AlloCare Monitoring
Managed with Standard of Care



Primary Outcome Measures :
  1. Overall reduction in Readmission Rate to hospital within 90 days (all causes) [ Time Frame: 90 days ]
    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.


Secondary Outcome Measures :
  1. Tacrolimus Variability (Time in Therapeutic Range,) at 3,6, and 12 months as a surrogate to adherence and compliance [ Time Frame: 3, 6, and 12 months ]
    Use of Allocare is hoped to empower patient self-care with improved monitoring with result in fewer readmissions after transplant and reduced clinic visits, better medication adherence, and fewer immunosuppression related complications when compared to standard of care.

  2. BPAR at 3, 6, and 12 months [ Time Frame: 3, 6, and 12 months ]
    Use of Allocare is hoped to empower patient self-care with improved monitoring with result in fewer readmissions after transplant and reduced clinic visits, better medication adherence, and fewer immunosuppression related complications when compared to standard of care.

  3. Patient satisfaction at 90 days [ Time Frame: 90 days ]
    Use of Allocare is hoped to empower patient self-care with improved monitoring with result in fewer readmissions after transplant and reduced clinic visits, better medication adherence, and fewer immunosuppression related complications when compared to standard of care. In addition, use of the app will lead to improved patient and provider satisfaction at 90 days.

  4. SF-36 change at 90 days [ Time Frame: 90 days ]
    Use of Allocare is hoped to empower patient self-care with improved monitoring with result in fewer readmissions after transplant and reduced clinic visits, better medication adherence, and fewer immunosuppression related complications when compared to standard of care.

  5. HbA1c monitoring (diabetic patients only) at 3,6, and 12 months [ Time Frame: 3, 6, and 12 months ]
    Use of Allocare is hoped to empower patient self-care with improved monitoring with result in fewer readmissions after transplant and reduced clinic visits, better medication adherence, and fewer immunosuppression related complications when compared to standard of care.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05033548


Contacts
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Contact: Shimul Shah, M.D. 5135589965 shahsu@ucmail.uc.edu

Locations
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United States, Alabama
University of Alabama Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Shamika Harris    203-934-6683    shamikawharris@uabmc.edu   
Principal Investigator: Thomas Kaleekal, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: David Estelle    317-962-1596    destelle1@iuhealth.org   
Principal Investigator: Chadi Hage, MD         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Sean O'Brien    913-574-0895    sobrien5@kumc.edu   
Principal Investigator: Aditi Gupta, MD         
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Stephanie Greer    913-574-0187    sgreer3@kumc.edu   
Principal Investigator: Andrija Vidic, MD         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Deepa Valvi    859-257-9443    deepa.valvi@uky.edu   
Principal Investigator: Malay Shah, MD         
United States, New York
ECMC State University of NY/University of Buffalo Recruiting
Buffalo, New York, United States, 14215
Contact: Anne Solbu    713-898-5280    asolbu@ecmc.edu   
Principal Investigator: Liise Kayler, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Rachel Rice       rachel.s.rice@duke.edu   
Principal Investigator: Matthew Hartwig, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Shavon Capers    843-792-8896    caperssh@musc.edu   
Principal Investigator: Derek Dubay, MD         
United States, Tennessee
University of Tennessee Recruiting
Memphis, Tennessee, United States, 38104
Contact: Gayle Gower    901-478-0614    egower@uthsc.edu   
Principal Investigator: Jason Vanatta, MD         
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Amy Mullican       amy.mullican@vumc.org   
Principal Investigator: Anil Julius Trindade, MD         
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Joel Sincaban-Angeles    608-262-7115    jsincaban@clinicaltrials.wisc.edu   
Principal Investigator: Ravi Dhingra, MD         
Principal Investigator: Neetika Garg, MD         
Sponsors and Collaborators
CareDx
Investigators
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Principal Investigator: Shimul Shah, M.D. University of Cincinnati
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Responsible Party: CareDx
ClinicalTrials.gov Identifier: NCT05033548    
Other Study ID Numbers: SN-C-00018
First Posted: September 5, 2021    Key Record Dates
Last Update Posted: July 19, 2022
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No