TransplantTEAMMATENCT05033548
Technology Enabled And Molecular Monitoring of the Allograft and Transplant rEcipient
An observational study of Transplant, run by CareDx at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transplant
- How many people
- 246 participants
- Where
- 10 sitesUnited States
- Study dates
- 26 Oct 2021to 31 Jul 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants with a single solid organ transplant of either Lung, Liver, Kidney or Heart, will be invited to participate.
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 12 years or above. (Gillick Competent)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Alabama Birmingham
Birmingham, Alabama, 35233
ECMC State University of NY/University of Buffalo
Buffalo, New York, 14215
Medical University of South Carolina
Charleston, South Carolina, 29425
Duke University Medical Center
Durham, North Carolina, 27710
Indiana University
Indianapolis, Indiana, 46202
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Kentucky
Lexington, Kentucky, 40536
University of Wisconsin
Madison, Wisconsin, 53792
University of Tennessee
Memphis, Tennessee, 38104
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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)
Read the 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.
- Conditions
- Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Managed with AlloCare Monitoring | Not described | |
| Managed with Standard of Care | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (5)
Tacrolimus Variability (Time in Therapeutic Range,) at 3,6, and 12 months as a surrogate to adherence and compliance
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.
Measured: 3, 6, and 12 months
BPAR at 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.
Measured: 3, 6, and 12 months
Patient satisfaction at 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.
Measured: 90 days
SF-36 change at 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.
Measured: 90 days
HbA1c monitoring (diabetic patients only) at 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.
Measured: 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start26 Oct 2021
- Primary completion2 Feb 2023
- Study completion31 Jul 2023
Why it stopped: Decision by Sponsor after careful review of study data available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 246 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- CareDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shimul Shah, M.D., Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033548
- Sponsor's protocol ID
- SN-C-00018
- Acronym
- TEAMMATE
- Status last verified
- Jun 2023
- First submitted
- 26 Aug 2021
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Enabled And Molecular Monitoring of the Allograft and Transplant rEcipient
- ClinicalTrials.gov ID
- NCT05033548
- Acronym / sponsor ID
- TEAMMATE / SN-C-00018
- Conditions
- Transplant
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Decision by Sponsor after careful review of study data available.
- Enrolment
- 246 participants (actual)
- Lead sponsor
- CareDxIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Managed with AlloCare Monitoring | – | – |
| Managed with Standard of Care | – | – |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with a single solid organ transplant of either Lung, Liver, Kidney or Heart, will be invited to participate.
Key inclusion criteria (2 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 12 years or above. (Gillick Competent)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
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
BPAR at 3, 6, and 12 months
Time frame: 3, 6, and 12 months
Patient satisfaction at 90 days
Time frame: 90 days
SF-36 change at 90 days
Time frame: 90 days
HbA1c monitoring (diabetic patients only) at 3,6, and 12 months
Time frame: 3, 6, and 12 months
Results and safety
The study was stopped early (reason given: Decision by Sponsor after careful review of study data available.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shimul Shah, M.D. principal investigator
University of Cincinnati
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplant, run by CareDx at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Decision by Sponsor after careful review of study data available.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall reduction in Readmission Rate to hospital within 90 days (all causes) (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.