Clinical trial NCT05260268: Technology Enabled Strategies to Promote Treatment Adherence in Liver Transplant
Official title: Technology Enabled Strategies to Promote Treatment Adherence in Liver Transplant
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Transplant; Complications
Cirrhosis
End Stage Liver DIsease
Medication Adherence
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-03-02
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a longitudinal intervention study utilizing diverse cohorts of liver transplant recipients. It is a 2-arm, patient-randomized controlled trial of de novo liver transplant recipients.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Liver transplant, the only cure for end-stage liver disease, is a costly and limited resource that increases survival. It is increasingly performed among older adults who have a higher burden of comorbidities, medical complexity, and are at risk of non-adherence. In addition, liver transplant recipients must manage complex immunosuppression regimens to maintain graft function. Inadequate immunosuppression adherence is common post-liver transplant and has many adverse consequences including liver graft rejection, graft failure, and re-transplantation. To maintain their health, liver transplant recipients must also self-manage regimens for multiple chronic conditions beyond liver transplant.

The TEST Trial intervention is a conceptual framework to address health system and patient level barriers to adherence. By following the Cumulative Complexity Model and the Multiple Chronic Conditions Model, this study focuses on liver transplant recipients and their involved caregivers. The TEST trial leverages the use of electronic health record and Way to Health (W2H) text message system to improve medication adherence.

TEST is a 2-arm, patient-randomized controlled trial at three large, diverse transplant centers: University of Pennsylvania (UPENN), Northwestern University (NU); University of Miami (UM). A total of 360 de novo LTRs age 50 or older (n=180 per arm) within 3 months of transplant will be recruited and randomized to intervention versus usual care for 18 months. Interviews will be conducted at baseline, 6, 12, and 18 months. The TEST intervention includes:

* Monthly W2H Adherence Assessment \& Clinician Alerts
* Medication Reminders
* Laboratory and Appointment Notifications
* Supplemental Self-Management Support

The primary objective of the study is to investigate the effectiveness of the TEST Trial to improve adherence to immunosuppressant and non-immunosuppressant medication regimens, functional health status, and health outcomes compared to usual care. Secondary objectives will measure study fidelity and cost effectiveness.

Eligibility criteria: Liver Transplant Recipient Inclusion Criteria:

* 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.

Care Partner Inclusion Criteria:

* 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.

Liver Transplant Recipient Exclusion Criteria:

* Liver transplant recipient who speaks neither English nor Spanish
* Any severe uncorrectable vision, hearing, or cognitive impairments that may impede study interviews

Care Partner Exclusion Criteria:

* Care partner who speaks neither English nor Spanish

Primary outcomes:
measure: 24 Hour Recall
timeFrame: 18 Months
Secondary outcomes:
measure: Tacrolimus Lab Values, ng/mL
timeFrame: 18 Months
measure: ASK-12
timeFrame: 18 Months
measure: EQ-5D-5L
timeFrame: 18 Months
measure: Alcohol, Tobacco, and Drugs Survey
timeFrame: 18 Months
measure: 30-Second Chair Stand, seconds
timeFrame: 18 Months
measure: Balance Test, seconds
timeFrame: 18 Months
measure: Grip Strength, pounds
timeFrame: 18 Months
measure: Liver Frailty Index
timeFrame: 18 Months
measure: Days Alive Out of Hospital
timeFrame: 18 Months
measure: Liver Graft Outcomes
timeFrame: 18 Months
measure: Post-Transplant Infection
timeFrame: 18 Months
measure: Mortality
timeFrame: 18 Months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Marina Serper, MD
role: PRINCIPAL_INVESTIGATOR
References: