Liver Transplant; ComplicationsTESTNCT05260268
Technology Enabled Strategies to Promote Treatment Adherence in Liver Transplant
A study testing TEST Intervention in people with Liver Transplant; Complications and Cirrhosis, run by University of Pennsylvania at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Transplant; Complications, Cirrhosis, End Stage Liver DIsease
- What is being tested?
- TEST Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 361 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Dec 2022to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northwestern University
Chicago, Illinois, 60208
University of Miami
Miami, Florida, 33146
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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.
- Being tested
- TEST Intervention
- Medical subject headings
- Fibrosis, End Stage Liver Disease, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEST InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No 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. |
| TEST Intervention | Experimental | 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 Receives: Behavioral: TEST Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 Months
Secondary outcomes (12)
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.
Measured: 18 Months
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.
Measured: 18 Months
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
Measured: 18 Months
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.
Measured: 18 Months
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
Measured: 18 Months
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.
Measured: 18 Months
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.
Measured: 18 Months
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.
Measured: 18 Months
Days Alive Out of Hospital
The number of days a patient spends alive and not hospitalized for any reason
Measured: 18 Months
Liver Graft Outcomes
The number of instances of liver graft rejection and liver graft failure post-transplant
Measured: 18 Months
Post-Transplant Infection
The number of instances of patient having an infection (bacterial, viral, or fungal) post-transplant
Measured: 18 Months
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
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Dec 2022
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marina Serper, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260268
- Sponsor's protocol ID
- 849575
- Acronym
- TEST
- Status last verified
- Jul 2026
- First submitted
- 22 Nov 2021
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not planning to make individual participant data available to other researchers.
Publications
Serper M, Burdzy A, Schaubel DE, Mason R, Banerjee A, Goldberg DS, Martin EF, Mehta SJ, Russell LB, Cheung AC, Ladner DP, Yoshino Benavente J, Wolf MS. Patient randomised controlled trial of technology enabled strategies to promote treatment adherence in liver transplantation: rationale and design of the TEST trial. BMJ Open. 2023 Sep 18;13(9):e075172. doi: 10.1136/bmjopen-2023-075172.
PubMed 37723108
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Enabled Strategies to Promote Treatment Adherence in Liver Transplant
- ClinicalTrials.gov ID
- NCT05260268
- Acronym / sponsor ID
- TEST / 849575
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 361 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No 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. |
| TEST Intervention | Experimental | Behavioral: TEST InterventionClinical 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEST InterventionThe 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. | Behavioural | TEST Intervention |
Primary outcome
24 Hour Recall
Time frame: 18 Months
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.
12 secondary outcomes
Tacrolimus Lab Values, ng/mL
Time frame: 18 Months
ASK-12
Time frame: 18 Months
EQ-5D-5L
Time frame: 18 Months
Alcohol, Tobacco, and Drugs Survey
Time frame: 18 Months
30-Second Chair Stand, seconds
Time frame: 18 Months
Balance Test, seconds
Time frame: 18 Months
Grip Strength, pounds
Time frame: 18 Months
Liver Frailty Index
Time frame: 18 Months
Days Alive Out of Hospital
Time frame: 18 Months
Liver Graft Outcomes
Time frame: 18 Months
Post-Transplant Infection
Time frame: 18 Months
Mortality
Time frame: 18 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Derived from this study: PubMed 37723108Serper M, Burdzy A, Schaubel DE, Mason R, Banerjee A, Goldberg DS, Martin EF, Mehta SJ, Russell LB, Cheung AC, Ladner DP, Yoshino Benavente J, Wolf MS. Patient randomised controlled trial of technology enabled strategies to promote treatment adherence in liver transplantation: rationale and design of the TEST trial. BMJ Open. 2023 Sep 18;13(9):e075172. doi: 10.1136/bmjopen-2023-075172.
- Individual participant dataSharing planned: No. We are not planning to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Serper, MD principal investigator
University of Pennsylvania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEST Intervention in people with Liver Transplant; Complications and Cirrhosis, run by University of Pennsylvania at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 Hour Recall (time frame: 18 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05260268, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.