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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

TEST Trial 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.Check my eligibility

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.See study design

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.

TEST Trial 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.

TEST Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

24 Hour Recall

Secondary outcome measures

30-Second Chair Stand

ASK-12

Days Alive Out of Hospital

+6 more

TEST 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

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Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,005 Previous Clinical Trials

42,881,849 Total Patients Enrolled

6 Trials studying Liver Cirrhosis

5,956 Patients Enrolled for Liver Cirrhosis

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

2,359 Previous Clinical Trials

4,315,143 Total Patients Enrolled

25 Trials studying Liver Cirrhosis

7,393 Patients Enrolled for Liver Cirrhosis

Marina Serper, MDPrincipal InvestigatorUniversity of Pennsylvania

1 Previous Clinical Trials

127 Total Patients Enrolled

Media Library

Liver Cirrhosis Research Study Groups: Usual Care, TEST Intervention

TEST Intervention (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05260268 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can new applicants still join this research protocol?

"According to the data on clinicaltrials.gov, this particular medical trial is no longer recruiting participants. It was first posted on September 1st 2022 and most recently updated August 4th 2022 - however there are an abundance of other studies searching for patients at this time (464 in total)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Technology Enabled Strategies to Promote Treatment Adherence in Liver Transplant

2022. "Technology Enabled Strategies to Promote Treatment Adherence in Liver Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05260268.

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