Telemedicine Based Remote Home Monitoring After Liver Transplantation

NCT03878329 | Completed

• 1 other identifier: TelehealthOLT
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

A significant opportunity exists to involve patients and their caregivers in more effective perioperative care and transition to home for transplant patients. Stakeholders were engaged through the University of Cincinnati Liver Transplant Program to prioritize changes in improving post transplant care. The initial findings indicated that increasing "care between visits" is the top priority for patients for improving function, quality of life and independence. Building on existing telehealth research, an enhanced home management program (HMP) to leverage and improve patient self-care following liver transplantation was developed, specifically by improving adherence, reducing readmissions and improving the transition from hospital to home. The improvement of care may have profound effect in the first 90 days after transplant on important long-term health parameters that affect clinical outcomes such as depression, weight gain, blood pressure control and diabetes management. With patient engagement, a randomized controlled trial is proposed comparing traditional provider-based care vs. traditional care with HMP. These two arms will need 50 patients in each arm with a 0.5 year follow up. Patients have said that the primary outcomes are quality of life, function and independence. To that end, the primary study outcomes are assessment of adherence, readmissions (90-day), patient satisfaction. The HMP model will advise providers, health care systems, and transplant centers how to improve patient care, especially among those at greatest risk of poor outcomes specifically minorities and those of low socioeconomic status.

Conditions

Liver Failure; Liver Transplant; Complications

Outcome Measures

Primary Outcomes (1)

• 90- day readmission

  Assess readmission

  90 days

Study Arms (2)

standard of care

NO INTERVENTION

standard of care treatment

remote home monitoring

EXPERIMENTAL

use of telemedicine based remote home monitoring

Behavioral: remote home monitoring

Interventions

remote home monitoring BEHAVIORAL

Will use telemedicine to guide behavior changes in outcomes

remote home monitoring

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects (≥ 18 years old) who are liver transplant recipients.
• Discharged home within 45 days of liver transplant.
• Able and willing to provide informed consent.

You may not qualify if:

• Post-transplant admission and care provided by University of Cincinnati Medical Center or rehab facility \> 45 days after liver transplant.
• Unable to have 4G wireless connectivity or wifi in their home.
• Patient has any form of psychiatric disorder or a condition that, in the opinion of the investigator, may hinder communication with the investigator.
• Inability to cooperate or communicate with the investigator.

Sponsors & Collaborators

• University of Cincinnati: lead

Related Publications (2)

• Lee TC, Kaiser TE, Alloway R, Woodle ES, Edwards MJ, Shah SA. Telemedicine Based Remote Home Monitoring After Liver Transplantation: Results of a Randomized Prospective Trial. Ann Surg. 2019 Sep;270(3):564-572. doi: 10.1097/SLA.0000000000003425.

  PMID: 31356267 RESULT

• Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.

  PMID: 36094829 DERIVED

MeSH Terms

Conditions

Liver Failure

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Non-blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery, Chief, Solid Organ Transplantation, Department of Surgery

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 18, 2019
• Study Start: January 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: December 1, 2020
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year after study completed.
• Access Criteria: investigator with HIPAA compliance