Solid Organ TransplantRebootNCT04721288
REmote moBile Outpatient mOnitoring in Transplant 2.0
A study testing Active communication through Reboot application and Generic communication through Reboot application in people with Solid Organ Transplant and Heart Transplant, run by University Health Network, Toronto.
Trial summary
This study is designed to determine if an innovative mobile health intervention designed to improve patient-provider communication can reduce unscheduled hospitalizations, and visits to the emergency department and ambulatory clinic in adult heart, liver, and kidney transplant patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Solid Organ Transplant, Heart Transplant, Liver Transplant
- What is being tested?
- Active communication through Reboot application and Generic communication through Reboot application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Jan 2026
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Solid organ (heart, liver, or kidney) transplant patients
- The ability to use a smartphone
- English speaking
Who cannot join
- Poor health literacy (reading level less than grade 5)
- Inability to follow instructions from the Reboot application
- Transfer to a non-University Health Network Hospital for follow-up and management
Trial locations and contacts
No sites are listed yet.
About this study
Official title: REmote moBile Outpatient mOnitoring in Transplant (Reboot) 2.0
This study is designed to determine if an innovative mobile health intervention designed to improve patient-provider communication can reduce unscheduled hospitalizations, and visits to the emergency department and ambulatory clinic in adult heart, liver, and kidney transplant patients.
Read the detailed description
Mobile health technologies such as smartphones and wearable devices can remotely monitor health. These technologies hold promise to improve health outcomes in a spectrum of patients by providing health care teams with better connectivity which may prompt more timely responses to questions and improvements to care.
The purpose of this study is to evaluate if solid organ transplant (SOT) recipients benefit from improved monitoring and removal of communication barriers as the most common reasons for readmission and mortality may be mitigated by clinical intervention. Additionally, medication adherence is critical in transplant patients to prevent graft rejection. We anticipate that remote monitoring will improve medication adherence/adjustments, and will allow for identification of early health issues, reducing preventable hospital readmissions. Thus, this study will determine if an innovative mobile health intervention, designed to improve patient-clinician communication, reduces unnecessary hospital readmission and visits to the emergency department and transplant clinic when utilized in addition to the standard of care telephone communication system. We will also incorporate clinical and continuous ambulatory physiologic data collected as part of the mobile health intervention to develop machine learning algorithms capable of identifying early indicators of adverse outcomes in adult heart, kidney, and liver transplant patients.
We hypothesize that: the delivery of personalized communication using a mobile health application will improve patient self-management resulting in a 50% reduction in preventable hospital readmission, and unscheduled visits to the emergency department and transplant clinic. With tailored communication through the mobile health application, we expect fewer standard of care phone messages for patients in the intervention group and patients with higher activity levels (average daily step-count) pre-transplantation will have lower index hospitalization length of stay. Finally, the large dataset collected from this study will allow novel machine learning-derived risk prediction models to more accurately predict adverse outcomes (e.g., organ rejection, infection, and death), compared to conventional regression models.
- Being tested
- Active communication through Reboot application, Generic communication through Reboot application
- Keywords
- mobile health, telemonitoring, transplantation, wearable sensors, solid organ transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active communication through Reboot applicationOther
Access to active communication with the transplant care team through Reboot application based asynchronous messaging for non-urgent issues, as well as personalized clinical notifications.
Generic communication through Reboot applicationOther
Access to generic messaging through Reboot application, and communication with the transplant care team through standard of care communication system.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 1 year of tailored communication with transplant care team through Reboot application in addition to standard of care communication system. Receives: Other: Active communication through Reboot application |
| Standard of Care Group | Sham comparator | 1 year of generic communication through Reboot application with communication with transplant care team through standard of care communication system. Receives: Other: Generic communication through Reboot application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unscheduled hospital admission or visit to emergency department or transplant clinic.
A composite score of unscheduled hospital admission, visit to the emergency department or ambulatory transplant clinic (i.e., total number of visits) will be calculated for each group at the pre-specified time intervals. A central adjudication committee will assess each readmission and visit to determine if they constitute a study event.
Measured: 1-month
Secondary outcomes (6)
EuroQol-5 (EQ-5D) Dimension questionnaire
The EQ-5D is a comprehensive and compact health status classification and health state preference questionnaire, widely used in many patient populations.
Measured: 1-month, 3-months, 12-months
Patient-Reported Outcomes Measurement Information System (PROMIS) tool
PROMIS is a single patient-centered questionnaire that measures and monitors several domains, including physical, mental, and social health. It is validated for use with the general population and individuals living with chronic disease.
Measured: 1-month, 3-months, 12-months
Graft survival rate
Transplanted organ survival rate will be calculated for each group at the end of the study period.
Measured: 12-months
Patient survival rate
Patient survival rate will be calculated for each group at the end of the study period.
Measured: 12-months
Easy Call interactions
The number of interactions that each group has with standard of care communication system ('Easy Call') will be compared.
Measured: 1-month, 3-months, 12-months
Index hospitalization length of stay
Participants activity level while on the transplant waiting list will be quantified by their average daily step count, and compared to the length of their index hospitalization.
Measured: 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study startApr 2023 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid Organ TransplantStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Ross, University Health Network, Toronto
- Investigators
- Heather Ross, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721288
- Sponsor's protocol ID
- 20-6082
- Acronym
- Reboot
- Status last verified
- Nov 2022
- First submitted
- 17 Jan 2021
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murray KR, Foroutan F, Amadio JM, Posada JD, Kozuszko S, Duhamel J, Tsang K, Farkouh ME, McDonald M, Billia F, Barber E, Hershman SG, Bhat M, Tinckam KJ, Ross HJ, McIntosh C, Moayedi Y. Remote Mobile Outpatient Monitoring in Transplant (Reboot) 2.0: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Oct 22;10(10):e26816. doi: 10.2196/26816.
PubMed 34528885
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REmote moBile Outpatient mOnitoring in Transplant (Reboot) 2.0
- ClinicalTrials.gov ID
- NCT04721288
- Acronym / sponsor ID
- Reboot / 20-6082
- Keywords
- mobile health, telemonitoring, transplantation, wearable sensors, solid organ transplant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 22 Jan 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.
This study is designed to determine if an innovative mobile health intervention designed to improve patient-provider communication can reduce unscheduled hospitalizations, and visits to the emergency department and ambulatory clinic in adult heart, liver, and kidney transplant patients.
Detailed description
Mobile health technologies such as smartphones and wearable devices can remotely monitor health. These technologies hold promise to improve health outcomes in a spectrum of patients by providing health care teams with better connectivity which may prompt more timely responses to questions and improvements to care.
The purpose of this study is to evaluate if solid organ transplant (SOT) recipients benefit from improved monitoring and removal of communication barriers as the most common reasons for readmission and mortality may be mitigated by clinical intervention. Additionally, medication adherence is critical in transplant patients to prevent graft rejection. We anticipate that remote monitoring will improve medication adherence/adjustments, and will allow for identification of early health issues, reducing preventable hospital readmissions. Thus, this study will determine if an innovative mobile health intervention, designed to improve patient-clinician communication, reduces unnecessary hospital readmission and visits to the emergency department and transplant clinic when utilized in addition to the standard of care telephone communication system. We will also incorporate clinical and continuous ambulatory physiologic data collected as part of the mobile health intervention to develop machine learning algorithms capable of identifying early indicators of adverse outcomes in adult heart, kidney, and liver transplant patients.
We hypothesize that: the delivery of personalized communication using a mobile health application will improve patient self-management resulting in a 50% reduction in preventable hospital readmission, and unscheduled visits to the emergency department and transplant clinic. With tailored communication through the mobile health application, we expect fewer standard of care phone messages for patients in the intervention group and patients with higher activity levels (average daily step-count) pre-transplantation will have lower index hospitalization length of stay. Finally, the large dataset collected from this study will allow novel machine learning-derived risk prediction models to more accurately predict adverse outcomes (e.g., organ rejection, infection, and death), compared to conventional regression models.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Active communication through Reboot application1 year of tailored communication with transplant care team through Reboot application in addition to standard of care communication system. |
| Standard of Care Group | Sham comparator | Other: Generic communication through Reboot application1 year of generic communication through Reboot application with communication with transplant care team through standard of care communication system. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Solid organ (heart, liver, or kidney) transplant patients
- The ability to use a smartphone
- English speaking
Key exclusion criteria (3 listed)
- Poor health literacy (reading level less than grade 5)
- Inability to follow instructions from the Reboot application
- Transfer to a non-University Health Network Hospital for follow-up and management
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active communication through Reboot applicationAccess to active communication with the transplant care team through Reboot application based asynchronous messaging for non-urgent issues, as well as personalized clinical notifications. | Other | Intervention Group |
| Generic communication through Reboot applicationAccess to generic messaging through Reboot application, and communication with the transplant care team through standard of care communication system. | Other | Standard of Care Group |
Primary outcome
Unscheduled hospital admission or visit to emergency department or transplant clinic.
Time frame: 1-month
A composite score of unscheduled hospital admission, visit to the emergency department or ambulatory transplant clinic (i.e., total number of visits) will be calculated for each group at the pre-specified time intervals. A central adjudication committee will assess each readmission and visit to determine if they constitute a study event.
6 secondary outcomes
EuroQol-5 (EQ-5D) Dimension questionnaire
Time frame: 1-month, 3-months, 12-months
Patient-Reported Outcomes Measurement Information System (PROMIS) tool
Time frame: 1-month, 3-months, 12-months
Graft survival rate
Time frame: 12-months
Patient survival rate
Time frame: 12-months
Easy Call interactions
Time frame: 1-month, 3-months, 12-months
Index hospitalization length of stay
Time frame: 1-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Derived from this study: PubMed 34528885Murray KR, Foroutan F, Amadio JM, Posada JD, Kozuszko S, Duhamel J, Tsang K, Farkouh ME, McDonald M, Billia F, Barber E, Hershman SG, Bhat M, Tinckam KJ, Ross HJ, McIntosh C, Moayedi Y. Remote Mobile Outpatient Monitoring in Transplant (Reboot) 2.0: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Oct 22;10(10):e26816. doi: 10.2196/26816.
- Individual participant dataSharing planned: No
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Viral Specific T-cells for Treatment of Viral Infections After Solid Organ Transplant
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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.
Heather Ross, MD principal investigator
University Health Network, Toronto
Questions about this trial
What is this clinical trial studying?
A study testing Active communication through Reboot application and Generic communication through Reboot application in people with Solid Organ Transplant and Heart Transplant, run by University Health Network, Toronto.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasbanoo Moayedi, MD (416-340-4800 ext. 4790, yas.moayedi@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unscheduled hospital admission or visit to emergency department or transplant clinic. (time frame: 1-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04721288, which also lists 1 linked publication.
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 16 Nov 2022.