REmote moBile Outpatient mOnitoring in Transplant 2.0 (Reboot)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Organ Transplant; Liver Transplant; Kidney Transplant; Heart Transplant
• Intervention / Treatment: Other: Active communication through Reboot application; Other: Generic communication through Reboot application

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 Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yasbanoo Moayedi, MD; Phone Number: 4790 416-340-4800; Email: yas.moayedi@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention Group; 1 year of tailored communication with transplant care team through Reboot application in addition to standard of care communication system.	Other: Active 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.
SHAM_COMPARATOR: Standard of Care Group; 1 year of generic communication through Reboot application with communication with transplant care team through standard of care communication system.	Other: Generic communication through Reboot application; Access to generic messaging through Reboot application, and communication with the transplant care team through standard of care communication system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	12-months
Patient survival rate	Patient survival rate will be calculated for each group at the end of the study period.	12-months
Easy Call interactions	The number of interactions that each group has with standard of care communication system ('Easy Call') will be compared.	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.	1-month

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Heather Ross, MD, University Health Network, Toronto

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2023
• Primary Completion (ANTICIPATED): September 1, 2025
• Study Completion (ANTICIPATED): January 1, 2026

Study Registration Dates

• First Submitted: January 17, 2021
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (ACTUAL): January 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: mobile health; transplantation; solid organ transplant; telemonitoring; wearable sensors
• Other Study ID Numbers: 20-6082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No