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REmote moBile Outpatient mOnitoring in Transplant 2.0

REmote moBile Outpatient mOnitoring in Transplant (Reboot) 2.0

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04721288
Acronym
Reboot
Enrollment
400
Registered
2021-01-22
Start date
2023-04-30
Completion date
2026-01-31
Last updated
2022-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Transplant, Kidney Transplant, Liver Transplant, Solid Organ Transplant

Keywords

mobile health, telemonitoring, transplantation, wearable sensors, solid organ transplant

Brief 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.

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.

Interventions

OTHERActive communication through Reboot application

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.

OTHERGeneric communication through Reboot application

Access to generic messaging through Reboot application, and communication with the transplant care team through standard of care communication system.

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Solid organ (heart, liver, or kidney) transplant patients * The ability to use a smartphone * English speaking

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Unscheduled hospital admission or visit to emergency department or transplant clinic.1-monthA 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.

Secondary

MeasureTime frameDescription
Patient-Reported Outcomes Measurement Information System (PROMIS) tool1-month, 3-months, 12-monthsPROMIS 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.
Graft survival rate12-monthsTransplanted organ survival rate will be calculated for each group at the end of the study period.
EuroQol-5 (EQ-5D) Dimension questionnaire1-month, 3-months, 12-monthsThe EQ-5D is a comprehensive and compact health status classification and health state preference questionnaire, widely used in many patient populations.
Easy Call interactions1-month, 3-months, 12-monthsThe number of interactions that each group has with standard of care communication system ('Easy Call') will be compared.
Index hospitalization length of stay1-monthParticipants 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.
Patient survival rate12-monthsPatient survival rate will be calculated for each group at the end of the study period.

Contacts

Primary ContactYasbanoo Moayedi, MD
yas.moayedi@uhn.ca416-340-4800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026