Clinical trial NCT04721288: REmote moBile Outpatient mOnitoring in Transplant 2.0
Official title: REmote moBile Outpatient mOnitoring in Transplant (Reboot) 2.0
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Solid Organ Transplant
Heart Transplant
Liver Transplant
Kidney Transplant
Keywords: mobile health
telemonitoring
transplantation
wearable sensors
solid organ transplant
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 400
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Unscheduled hospital admission or visit to emergency department or transplant clinic.
timeFrame: 1-month
Secondary outcomes:
measure: EuroQol-5 (EQ-5D) Dimension questionnaire
timeFrame: 1-month, 3-months, 12-months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) tool
timeFrame: 1-month, 3-months, 12-months
measure: Graft survival rate
timeFrame: 12-months
measure: Patient survival rate
timeFrame: 12-months
measure: Easy Call interactions
timeFrame: 1-month, 3-months, 12-months
measure: Index hospitalization length of stay
timeFrame: 1-month
Other outcomes:
Locations:
Study officials:
affiliation: University Health Network, Toronto
name: Heather Ross, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.