Technology Enabled Strategies to Promote Treatment Adherence in Liver Transplant

Cirrhosis Clinical Trial

— TEST  

Official title:

Technology Enabled Strategies to Promote Treatment Adherence in Liver Transplant

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05260268
• Other study ID #: 849575
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: January 1, 2027

Study information

• Verified date: May 2024
• Source: University of Pennsylvania
• Contact: Richard Mason, PharmD
• Phone: (215) 662-3904
• Email: richard.mason[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: January 1, 2027
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• End Stage Liver DIsease
• Liver Diseases
• Liver Transplant; Complications
• Medication Adherence

Intervention

Behavioral:
• TEST Intervention
The TEST intervention will include standard post-transplant care and include additional touchpoints utilizing the Way to Health system. Details on this intervention are included in the study arm description.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	University of Miami	Miami	Florida
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 Hour Recall	Patient self-report of how many pills and how often each medicine was taken over the last 24 hours. Patients will also be asked about the medical indication for each drug. Correct dosing will be measured as a yes/no per drug, having properly shown dose (number of pills), spacing (hours between doses), frequency (times per day), and total pills/day.	18 Months
Secondary	Tacrolimus Lab Values, ng/mL	Tacrolimus lab values (ng/mL) will be tracked. Patient immunosuppression variability will be assessed with the tacrolimus coefficient of variation (COV) (100 x standard deviation/mean tacrolimus concentration) and the medication level variability index (MLVI, standard deviation of at least three values. The range for COV is 0-1 , and the MLVI range generally falls between 0-9. Nonadherence to medication can be seen in values >= 0.30 for COV and greater than 2.5-2.6 for MLVI.; Fidelity will be measured through the number of completed monthly assessments, patient/caregiver engagement with text messages, and percent care alerts with clinical actions taken.	18 Months
Secondary	ASK-12	The ASK-12 is a self-report scale that assess general medication attitudes and beliefs. The scale consists of 12 items across three domains (inconvenience/forgetfulness, treatment beliefs, and behaviors), with responses ranging from "Strong Disagree" to "Strongly Agree". The score can range from 12-60 with higher scores representing greater barriers to adherence.	18 Months
Secondary	EQ-5D-5L	Patient health outcomes will be measured using the EQ-5D-5L questionnaire. This tool measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression, and self-rated health. Each dimension has 5 levels: no problem, sight problems, moderate problems, severe problems, and extreme problems. Patient choice for each results in a 1-digit number that expresses the level selected, and the digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. A lower score indicates a good health state while a higher score represents a more severe health state. In addition, there is a visual analogue scale (VAS) to indicate the general health status with 100 indicating the best health status and 0 being the worst health state	18 Months
Secondary	Alcohol, Tobacco, and Drugs Survey	Health-related quality of life (HRQOL) will be measured in part by the Alcohol, Tobacco, and Drugs Survey. This is a questionnaire asking participants about their recent alcohol, drug, and tobacco use. The questions related to alcohol use are adapted from the AUDIT-C form. The tobacco and marijuana sections ask participants about their current and past smoking habits as well as the type of tobacco and marijuana they used. Those regarding alcohol assess the frequency of drinking and the quantity of drinks per drinking sessions.	18 Months
Secondary	30-Second Chair Stand, seconds	The 30-Second Chair Stand test is a measure of leg strength and endurance. The patient is asked to move from a seated position with arms crossed over the into the standing position and then sit back down. The test administrator counts the number of times the patient comes to a full standing position in 30 seconds. The number of successful completions indicates the risk of fall. This score is dependent on age category with <14 for men and <12 for women between the age of 60-64 indicating a greater risk for all	18 Months
Secondary	Balance Test, seconds	The Balance Test is a measure of balance in participants. The patient is asked to hold three poses for up to 10 seconds: a side-by-side stand, a semi-tandem stand, and a tandem stand. The patient must be able to stand unassisted without the use of a cane or walker. The test administrator will count up to 10 seconds and record the time if the participant is not able to hold the pose for the full amount. Participants are given one point for each pose that they can hold for 10 seconds. Individuals with a lower amount of points have poorer balance and are deemed at great risk for falls.	18 Months
Secondary	Grip Strength, pounds	Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It is measured in pounds. Participants are asked to squeeze a hand dynamometer as hard as possible for five seconds until a maximum number of pounds is reached. The test administrator records this maximum value and asks the participant to repeat the exercise two more times with a five second break in between. The three maximum values are averaged to obtain a final score. The lower the final score, the lower a persons grip strength is and thus their probability of physical frailty.	18 Months
Secondary	Liver Frailty Index	The Liver Frailty Index (LFI) is a calculated measurement from the results obtained in the 30-second chair stand, balance test, and grip strength assessments. The LFI measurement is on a scale of 0-10 with 0 being the most healthy and robust and 10 being the most frail. This value is calculated using a normative sample of 1405 outpatients with cirrhosis awaiting liver transplantation.	18 Months
Secondary	Days Alive Out of Hospital	The number of days a patient spends alive and not hospitalized for any reason	18 Months
Secondary	Liver Graft Outcomes	The number of instances of liver graft rejection and liver graft failure post-transplant	18 Months
Secondary	Post-Transplant Infection	The number of instances of patient having an infection (bacterial, viral, or fungal) post-transplant	18 Months
Secondary	Mortality	If a patient passes away in the study, the date of death and cause of death will be recorded along with the number of days death occurred post-transplant	18 Months