NCT04721288

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
2.2 years until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

2.4 years

First QC Date

January 17, 2021

Last Update Submit

November 10, 2022

Conditions

Solid Organ TransplantHeart TransplantLiver TransplantKidney Transplant

Keywords

mobile healthtelemonitoringtransplantationwearable sensorssolid organ transplant

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • EuroQol-5 (EQ-5D) Dimension questionnaire

    1-month, 3-months, 12-months

  • Patient-Reported Outcomes Measurement Information System (PROMIS) tool

    1-month, 3-months, 12-months

  • Graft survival rate

    12-months

  • Patient survival rate

    12-months

  • Easy Call interactions

    1-month, 3-months, 12-months

  • +1 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Standard of Care Group

SHAM COMPARATOR

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

Interventions

Active communication through Reboot applicationOTHER

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 Group
Generic communication through Reboot applicationOTHER

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

Standard of Care Group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 34528885DERIVED

Study Officials

  • Heather Ross, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasbanoo Moayedi, MD

CONTACT

416-340-4800yas.moayedi@uhn.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Division of Cardiology

Study Record Dates

First Submitted

January 17, 2021

First Posted

January 22, 2021

Study Start

April 1, 2023

Primary Completion

September 1, 2025

Study Completion

January 1, 2026

Last Updated

November 16, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share