REmote moBile Outpatient mOnitoring in Transplant 2.0

Not Applicable

Not yet recruiting

• Conditions: Solid Organ Transplant; Liver Transplant; Kidney Transplant; Heart Transplant
• Interventions: Other: Active communication through Reboot application; Other: Generic communication through Reboot application

• Registration Number: NCT04721288
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study First Submitted: 2021-01-17
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-22
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-10
• Last Update Posted: 2022-11-16
• Study Start: 2023-04
• Primary Completion: 2025-09
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Active communication through Reboot application	1 year of tailored communication with transplant care team through Reboot application in addition to standard of care communication system.
Standard of Care Group	Generic communication through Reboot application	1 year of generic communication through Reboot application with communication with transplant care team through standard of care communication system.

Primary Outcome Measures

Name	Time	Method
Unscheduled hospital admission or visit to emergency department or transplant clinic.	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.

Secondary Outcome Measures

Name	Time	Method
Easy Call interactions	1-month, 3-months, 12-months	The number of interactions that each group has with standard of care communication system ('Easy Call') will be compared.
EuroQol-5 (EQ-5D) Dimension questionnaire	1-month, 3-months, 12-months	The EQ-5D is a comprehensive and compact health status classification and health state preference questionnaire, widely used in many patient populations.
Patient survival rate	12-months	Patient survival rate will be calculated for each group at the end of the study period.
Patient-Reported Outcomes Measurement Information System (PROMIS) tool	1-month, 3-months, 12-months	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.
Graft survival rate	12-months	Transplanted organ survival rate will be calculated for each group at the end of the study period.
Index hospitalization length of stay	1-month	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.