TEST Intervention for Liver Transplant Adherence

(TEST Trial)

Recruiting at 2 trial locations

Overseen By Richard Mason, PharmD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Severe vision, hearing, cognitive impairments

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

360 Participants Needed

Trial Summary

What is the purpose of this trial?

Liver transplantation is increasingly performed for older adults with multiple comorbidities. Medication adherence is key to maintaining proper function of the transplanted liver and optimize health; however, adhering to post-transplant treatment is complex. This trial will study how available technology combined with transplant center resources and caregiver support can optimize medication adherence, quality of life, and health outcomes among new liver transplant recipients at 3 centers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on helping you stick to your post-transplant medication plan.

What data supports the effectiveness of the TEST Intervention treatment for liver transplant adherence?

The research suggests that interventions aimed at improving medication adherence in liver transplant patients can lead to better health outcomes, such as fewer rejection episodes and improved liver enzyme levels. However, the effectiveness of these interventions varies, and more rigorous studies are needed to confirm their benefits. ^{1 2 3 4 5}

Is the TEST Intervention safe for liver transplant patients?

The available research focuses on improving medication adherence in liver transplant patients, but it does not provide specific safety data for the TEST Intervention itself. The studies suggest that adherence interventions are generally well-received and do not increase outpatient costs, but more research is needed to confirm their safety and effectiveness. ^{1 3 5 6 7}

How is the TEST Intervention treatment different from other treatments for liver transplant adherence?

The TEST Intervention is unique because it focuses on improving adherence through a brief, personalized psychological approach, providing education, skills, and resources to overcome barriers to adherence, unlike traditional treatments that may not address these behavioral aspects. ^{1 3 6 7 8}

Research Team

Marina Serper, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for adults over 18 who've had a liver transplant within the last 3 months, speak English or Spanish, live at home, and are comfortable using a cell phone and internet. It's not for those with severe vision, hearing, or cognitive issues that could interfere with study participation.

Inclusion Criteria

I am over 18 and have received a liver transplant.

Liver Transplant recipients who are English or Spanish-speaking

Liver Transplant recipients whose patient or caregiver owns a cell phone and is comfortable receiving text messages and/or using internet in home.

Exclusion Criteria

Any severe uncorrectable vision, hearing, or cognitive impairments that may impede study interviews

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the TEST intervention or usual care, focusing on medication adherence and health outcomes

18 months

Monthly visits and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• TEST Intervention

Trial Overview The study examines how technology like smartphones and online resources can help liver transplant patients stick to their medication schedules. It aims to improve life quality and health outcomes by leveraging caregiver support and transplant center tools.

Participant Groups

Group I: TEST Intervention Experimental Treatment 1 Intervention

Clinical activities for Usual Care will also be provided in the TEST arm. The TEST intervention is a technology-enabled strategy to routinely monitor regimen use, adherence, and persistence via a 'low touch', easy to use, online behavioral toolkit - Way to Health . It was developed by University of Pennsylvania researchers to automate behavioral intervention. The TEST approach includes monthly adherence assessments, with tailored adherence support. The following components will be included in the intervention: * Monthly W2H Adherence Assessment \& Clinician Alerts * Medication Reminders * Laboratory and Appointment Notifications * Supplemental Self-Management Support

Group II: Usual Care Active Control 1 Intervention

Usual care refers to the normal standard clinical practices immediately post-transplant to the 18 months following. Liver Transplant Recipients at sites have lab values taken weekly for the first 8-10 weeks post-transplant, shifting to every 2-4 weeks for the next 3-4 months, then monthly to every 3 months thereafter depending on clinical needs. All sites follow a similar schedule of tapering clinic visits ranging from weekly in the first 4 weeks to every 2-4 weeks in months 4-6, every 3-6 months in months 7 12, and every 6 months in months 12-24. All sites assign each patient to a specific transplant coordinator, first paired with a transplant surgeon (first 3-6 months), and then a transplant hepatologist for the remainder of follow-up. All patients and caregivers receive standard medication teaching prior to hospital discharge and then ad hoc. No routine text message reminders, caregiver reminders, or adherence alerts are used in usual care.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

A tailored intervention aimed at improving adherence among liver transplant recipients has been implemented, focusing on education and resources to overcome barriers to adherence.

The intervention has received positive feedback from patients and healthcare providers, and adherence is monitored at multiple time points (1, 3, 6, and 12 months) to ensure ongoing support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brief psychological intervention to improve adherence following transplantation. Lisson, GL., Rodrigue, JR., Reed, AI., et al.[2021]

A review of 41 studies on adherence interventions for solid organ transplant recipients found that most interventions did not improve transplant outcomes, with none of the 21 randomized controlled trials showing any positive effects.

Some interventions were associated with a higher rate of adverse events, suggesting that current strategies may not only be ineffective but could also pose risks, highlighting the need for more targeted and engaging approaches for non-adherent patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of immunosuppressant adherence interventions in transplant recipients: Decoding the streetlight effect. Duncan, S., Annunziato, RA., Dunphy, C., et al.[2019]

The Improving Medication Adherence trial targets non-adherent adolescent liver transplant recipients to assess whether a remote intervention can reduce the incidence of biopsy-confirmed rejection, using a novel adherence biomarker to identify at-risk patients.

This study employs a rigorous design with objective outcome measures and monitoring for potential adverse effects, addressing common biases in adherence research and ensuring that the intervention's safety and efficacy are thoroughly evaluated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The improving Medication Adherence in Adolescents and young adults following Liver Transplantation (iMALT) multisite trial: Design and trial implementation considerations. Shemesh, E., Duncan-Park, S., Mazariegos, G., et al.[2023]

The study involved 205 adult transplant recipients and demonstrated that a tailored behavioral intervention significantly improved medication adherence, with a 16% increase in dosing adherence in the intervention group compared to the control group (95.1% vs 79.1%; p < 0.001).

Although the intervention improved adherence, the 5-year clinical event-free survival rates were 82.5% for the intervention group and 72.5% for the control group, indicating a trend towards better outcomes, but not statistically significant (p = 0.18).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a medication adherence enhancing intervention in transplantation: The MAESTRO-Tx trial. Dobbels, F., De Bleser, L., Berben, L., et al.[2022]

A clinical program aimed at improving medication adherence in 23 children who had liver transplants showed a significant reduction in high alanine aminotransferase levels after the intervention, indicating better liver function.

The intervention also led to a decrease in rejection episodes, with none occurring after the protocol, suggesting that increased clinic visits for non-adherent patients may enhance overall health outcomes, although further studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving adherence to medications in pediatric liver transplant recipients. Shemesh, E., Annunziato, RA., Shneider, BL., et al.[2022]

The Pediatric Liver/Liver Transplant Program at Mount Sinai has developed a comprehensive adherence-monitoring program that includes standardized assessments and medication blood level checks, highlighting the need for objective methods to reliably detect non-adherence in pediatric liver transplant patients.

Preliminary findings suggest that addressing psychosocial factors, such as post-traumatic stress disorder, could be crucial in improving medication adherence, emphasizing the importance of integrating adherence assessment into clinical practice for better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-adherence to medications following pediatric liver transplantation. Shemesh, E.[2013]

A study involving 187 liver transplant patients showed that switching from a twice-daily to a once-daily tacrolimus formulation is safe and effective, with no significant changes in liver function or increased rejection episodes after conversion.

Although serum tacrolimus levels initially decreased one month after the switch, they normalized by six months, indicating that the once-daily regimen can maintain therapeutic levels without compromising patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful conversion from twice-daily to once-daily tacrolimus in liver transplantation: observational multicenter study. Dopazo, C., Rodriguez, R., Llado, L., et al.[2013]

In a study of 54 youth who underwent liver transplantation, lab adherence to necessary testing significantly decreased over time, with factors like being from a single-parent household and having no history of early rejection linked to higher rates of non-adherence.

Lab non-adherence was found to correlate with medication non-adherence and worse clinical outcomes, such as increased hospital visits and liver-related complications, highlighting the need for systematic monitoring to improve patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to laboratory testing in pediatric liver transplant recipients. Ryan, JL., Dandridge, LM., Fischer, RT.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A brief psychological intervention to improve adherence following transplantation. [2021]

2. Denmark pubmed.ncbi.nlm.nih.gov

A systematic review of immunosuppressant adherence interventions in transplant recipients: Decoding the streetlight effect. [2019]

3. England pubmed.ncbi.nlm.nih.gov

The improving Medication Adherence in Adolescents and young adults following Liver Transplantation (iMALT) multisite trial: Design and trial implementation considerations. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of a medication adherence enhancing intervention in transplantation: The MAESTRO-Tx trial. [2022]

5. Denmark pubmed.ncbi.nlm.nih.gov

Improving adherence to medications in pediatric liver transplant recipients. [2022]

6. Denmark pubmed.ncbi.nlm.nih.gov

Non-adherence to medications following pediatric liver transplantation. [2013]

7. Denmark pubmed.ncbi.nlm.nih.gov

Successful conversion from twice-daily to once-daily tacrolimus in liver transplantation: observational multicenter study. [2013]

8. Denmark pubmed.ncbi.nlm.nih.gov

Adherence to laboratory testing in pediatric liver transplant recipients. [2022]