REmote moBile Outpatient mOnitoring in Transplant 2.0

NCT ID: NCT04721288

Last Updated: 2022-11-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2026-01-31

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.

Conditions

Solid Organ Transplant; Heart Transplant; Liver Transplant; Kidney Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

1 year of tailored communication with transplant care team through Reboot application in addition to standard of care communication system.

Group Type: EXPERIMENTAL

Active communication through Reboot application

Intervention Type: OTHER

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.

Standard of Care Group

1 year of generic communication through Reboot application with communication with transplant care team through standard of care communication system.

Group Type: SHAM_COMPARATOR

Generic communication through Reboot application

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Heather Ross

Head, Division of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heather Ross, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Central Contacts

Yasbanoo Moayedi, MD

Role: CONTACT

yas.moayedi@uhn.ca

416-340-4800 ext. 4790

References

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.

Reference Type: DERIVED

PMID: 34528885 (View on PubMed)

Other Identifiers

20-6082

Identifier Type: -

Identifier Source: org_study_id