REmote moBile Outpatient mOnitoring in Transplant 2.0

Kidney Transplant Clinical Trial

— Reboot  

Official title:

REmote moBile Outpatient mOnitoring in Transplant (Reboot) 2.0

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04721288
• Other study ID #: 20-6082
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2023
• Est. completion date: January 2026

Study information

• Verified date: November 2022
• Source: University Health Network, Toronto
• Contact: Yasbanoo Moayedi, MD
• Phone: 416-340-4800
• Email: yas.moayedi[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: January 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Transplant
• Kidney Transplant
• Liver Transplant
• Solid Organ Transplant

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Graft survival rate	Transplanted organ survival rate will be calculated for each group at the end of the study period.	12-months
Secondary	Patient survival rate	Patient survival rate will be calculated for each group at the end of the study period.	12-months
Secondary	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
Secondary	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