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Liver FailureTelehealthOLTNCT03878329

Telemedicine Based Remote Home Monitoring After Liver Transplantation

A study testing remote home monitoring in people with Liver Failure and Liver Transplant; Complications, run by University of Cincinnati.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
remote home monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
1 Jan 2017to 1 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: Randomized Prospective Trial of Telemedicine Based Remote Home Monitoring After Liver Transplantation

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.

Read the detailed description

The successful care of patients undergoing liver transplantation and support of their caregivers consumes significant personal, institutional and community resources before and after surgery. Depression and anxiety are common after transplant, leading to apprehension about the ability to care successfully for oneself and poor adherence with complex medication and health behavior regimens.1,2 Although a patient's quality of life improves immediately following transplantation, when compared with the general population the vast majority of liver transplant recipients have significant deficiencies in most quality of life domains.3,4 This is most evident in minorities and patients of low socioeconomic status who have difficulty adjusting to the demands of complex medical and surgical care and are challenged by lack of literacy and cultural bias.5-7 Indeed, the reoperation and readmission rate in the first 90 days are the highest of any surgery performed in the United States.8 Effective perioperative care is critical following surgery in this high acuity patient population. Optimizing care in the perioperative period should improve recovery and outcomes, including depression, general health maintenance and long-term adherence.9,10 While practice guidelines for care after liver transplant exist, they lack specifics and are based on outdated models that do not reflect patient preferences, needs or expectations. Improving current processes in health care delivery before and after liver transplantation is critical to optimize outcomes that matter: survival, function, and independence. 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.11 Through a stakeholder engagement process with the University of Cincinnati Liver Transplant Program designed to find ways to improve post transplant care, increasing "care between visits" is the top priority for patients to improve function, quality of life and independence. Patients said that medication adherence and hospital readmissions are their largest barrier to success, and that they believe care immediately post-transplant in the first 90 days is the most important determinant of long-term outcomes. A twenty-patient pilot program assessed the feasibility of a patient-designed telehealth monitoring program after liver transplant, and it met with an extraordinary level of enthusiasm by our patients. In this proposal, the ability of this home management program (HMP) will be tested, developed by patients for patients, to improve transition care from hospital to home and patient adherence with a self-care regimen following liver transplantation.

The medical community must develop innovative health delivery systems following complex surgeries like transplantation in order to maximize post-operative care, adherence to a new and complex self-care regimen, independence, and ultimately survival. Our proposed telehealth delivery model will optimize the quality, efficiency and outcomes of post-discharge care following liver transplantation. 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. The objective of this proposal with the following specific aims:

Aim 1: Perform a randomized clinical trial to evaluate the impact of an enhanced, telehealth-based home management program (HMP) on medication and behavioral self-care adherence rates, and on 90-day and 1-year readmission rates following discharge for liver transplantation.

Hypothesis: Through enhanced patient engagement, HMP will increase medication and self-care adherence rates and reduce 90-day and 1-year readmission rates when compared to a traditional care model.

SubAim 1A: To determine whether underserved and minority patients achieve greater benefit from the HMP compared with more advantaged patient populations.

Aim 2: Evaluate the impact of the HMP on more distal clinical outcomes post liver transplantation including weight control, diabetes management, blood pressure regulation and depression.

Hypothesis: Enhanced home monitoring will have persisting health benefits beyond the 90-day time frame of the HMP intervention on a variety of chronic disease measures important in this population, including weight loss, diabetes management, blood pressure control, and depression.

Being tested
remote home monitoring
Medical subject headings
Liver Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • remote home monitoringBehavioural

    Will use telemedicine to guide behavior changes in outcomes

Study groups in NCT03878329
Study groupRoleWhat they receive
standard of careNo interventionstandard of care treatment
remote home monitoringExperimentaluse of telemedicine based remote home monitoring
Receives: Behavioral: remote home monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 90- day readmission

    Assess readmission

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2019
  2. Study start1 Jan 2017
  3. Primary completion1 Jan 2019
  4. Study completion1 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03878329
Sponsor's protocol ID
TelehealthOLT
Acronym
TelehealthOLT
Status last verified
Jun 2021
First submitted
14 Mar 2019
Last updated
1 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Protocol will be share

Publications

  • 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.

    PubMed 31356267
  • 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.

    PubMed 36094829

Questions about this trial

What is this clinical trial studying?

A study testing remote home monitoring in people with Liver Failure and Liver Transplant; Complications, run by University of Cincinnati.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

90- day readmission (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03878329, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.

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