Technology Enabled Strategies to Promote Treatment Adherence in Liver Transplant

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 18 years or older

• Within 3 months of liver transplant

• English or Spanish-speaking

• Home-dwelling\*

• Patient or care partner owns a smart phone and is comfortable receiving text messages and/or using the internet on the smart phone.

• \*The definition of home includes hotel or short-term housing. Patients who are going to a rehabilitation or skilled nursing facility (SNF) immediately after transplant may still be recruited if the site-PI/Co-I determines they are likely to be discharged to home within 3 months post-transplant.

• 18 years or older

• English or Spanish speaking

• Care partner has access to a smart phone and is comfortable receiving text messages and/or using the internet on the smart phone.

Locations
United States
Florida
University of Miami
RECRUITING
Miami
Illinois
Northwestern University
RECRUITING
Chicago
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Richard Mason, PharmD
richard.mason@pennmedicine.upenn.edu
(215) 662-3904
Backup
Marina Serper, MD
marinas2@pennmedicine.upenn.edu
(215) 349-8222
Time Frame
Start Date: 2022-12-01
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 360
Treatments
No_intervention: Usual Care
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.
Experimental: TEST 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
Authors
Josh Levitsky
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov