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Behavioral Intervention

TEST Intervention for Liver Transplant Adherence (TEST Trial)

N/A

Recruiting

Led By Marina Serper, MD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Liver Transplant recipients who are 18 years or older

Liver Transplant recipients who are home-dwelling

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on treatment adherence strategies rather than medications or procedures, it does not directly involve side effects related to medical interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 18 and have received a liver transplant.

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I have had a liver transplant and live at home.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

24 Hour Recall

Secondary study objectives

30-Second Chair Stand, seconds

ASK-12

Alcohol, Tobacco, and Drugs Survey

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TEST InterventionExperimental Treatment1 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 CareActive Control1 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.

0 / 2Eligibility criteria met