Liver Transplant RecipientsALTERNCT02320422
Adult Liver Transplant Enhanced Care
A study testing Behavioral Telehealth in people with Liver Transplant Recipients, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The purpose of this study is to pilot-test a tailored telemetric intervention to improve adherence to medications in adults who had a liver transplant and are presently non-adherent (as measured by tacrolimus levels). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant Recipients
- What is being tested?
- Behavioral Telehealth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is at least 18 years of age.
- The patient received a liver transplant at least 2 years prior to initiation of the research protocol.
- The patient is able to provide consent (i.e. is not encephalopathic or does not have significant cognitive impairment). Consent may be obtained either by phone or in person (following a script) and is documented by the researcher.
- The patient is prescribed tacrolimus (either brand or generic formulation).
- The patient is not receiving Hepatitis C treatment during the intervention (given this can affect levels of tacrolimus and adherence behaviors)
- Thee patient has been seen in the liver transplant clinic at least once in the last two years.
- The patient's MLVI value was ≥ 2, with at least 3 levels present to make this determination. Only tacrolimus levels drawn in the outpatient setting will be included in SD calculations. Tacrolimus levels in the inpatient setting (i.e. during a hospitalization) will be excluded.
- The patient speaks English or Spanish at a level that allows him/her to understand the study procedures and consent to the study.
Who cannot join
- The patient received a liver transplant less than 2 years prior to enrollment.
- The patient received a dual transplant (i.e. liver and kidney).
- The treating physician has instructed the patient not to obtain tacrolimus levels for at least one year in the past year.
- The patient does not understand the study procedures. This will be verified by asking the patient to repeat the study procedures.
- The patient is actively psychotic or severely disoriented due to any cause, including hepatic encephalopathy (temporary exclusion) or severe cognitive impairment.
- The patient is not medically stable or is hospitalized (temporary exclusion until stabilized).
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: An Intervention to Improve Adherence to Medications in Adults With Liver Transplants
The purpose of this study is to pilot-test a tailored telemetric intervention to improve adherence to medications in adults who had a liver transplant and are presently non-adherent (as measured by tacrolimus levels).
Read the detailed description
Adult patients who received a liver transplant and for whom there are at least 3 tacrolimus blood levels within the last year are eligible for the study. Patients will be recruited from amongst the roster of liver transplant recipients treated at the Recanati-Miller Transplant Institute at Mount Sinai. The intervention will be pilot-tested on up to 15 non-adherent patients. Patients will be identified using an innovative biomarker for non-adherence-by calculating the degree of fluctuation between individual medication blood levels. The telemetric intervention (administered via telephone, or interactive video chat applications such as FaceTime ® or Skype ®) will enable the intervention team (IT) to address non-adherence from a remote location, using a structured, tailored approach that accommodates specific patient needs. The approach includes a focus on psychological avoidance.
- Conditions
- Liver Transplant Recipients
- Being tested
- Behavioral Telehealth
- Keywords
- liver transplant, medication adherence, intervention
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral TelehealthBehavioural
The telemetric intervention (administered via telephone, or interactive video chat applications such as FaceTime ® or Skype ®) will enable the intervention team (IT) to address non-adherence from a remote location, using a structured, tailored approach
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Telehealth | Experimental | Not described Receives: Behavioral: Behavioral Telehealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Level Variability Index (MLVI)
The degree of fluctuation of tacrolimus blood levels (calculated as the standard deviation, SD, of tacrolimus).
Measured: up to 1 year
Secondary outcomes (3)
Incidence of biopsy-proven rejection
The number of incidences of liver transplant rejection (as proven by biopsy).
Measured: up to 1 year
ALT
Liver enzyme levels - mean/maximum levels of ALT
Measured: up to 1 year
Incidence of hospitalizations
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant RecipientsStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eyal Shemesh, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320422
- Sponsor's protocol ID
- GCO 14-1876
- Acronym
- ALTER
- Status last verified
- Dec 2016
- First submitted
- 16 Dec 2014
- Last updated
- 9 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention to Improve Adherence to Medications in Adults With Liver Transplants
- ClinicalTrials.gov ID
- NCT02320422
- Acronym / sponsor ID
- ALTER / GCO 14-1876
- Conditions
- Liver Transplant Recipients
- Keywords
- liver transplant, medication adherence, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 19 Dec 2014 (estimated)
- 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.
The purpose of this study is to pilot-test a tailored telemetric intervention to improve adherence to medications in adults who had a liver transplant and are presently non-adherent (as measured by tacrolimus levels).
Detailed description
Adult patients who received a liver transplant and for whom there are at least 3 tacrolimus blood levels within the last year are eligible for the study. Patients will be recruited from amongst the roster of liver transplant recipients treated at the Recanati-Miller Transplant Institute at Mount Sinai. The intervention will be pilot-tested on up to 15 non-adherent patients. Patients will be identified using an innovative biomarker for non-adherence-by calculating the degree of fluctuation between individual medication blood levels. The telemetric intervention (administered via telephone, or interactive video chat applications such as FaceTime ® or Skype ®) will enable the intervention team (IT) to address non-adherence from a remote location, using a structured, tailored approach that accommodates specific patient needs. The approach includes a focus on psychological avoidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral Telehealth | Experimental | Behavioral: Behavioral Telehealth |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patient is at least 18 years of age.
- The patient received a liver transplant at least 2 years prior to initiation of the research protocol.
- The patient is able to provide consent (i.e. is not encephalopathic or does not have significant cognitive impairment). Consent may be obtained either by phone or in person (following a script) and is documented by the researcher.
- The patient is prescribed tacrolimus (either brand or generic formulation).
- The patient is not receiving Hepatitis C treatment during the intervention (given this can affect levels of tacrolimus and adherence behaviors)
Key exclusion criteria (6 listed)
- The patient received a liver transplant less than 2 years prior to enrollment.
- The patient received a dual transplant (i.e. liver and kidney).
- The treating physician has instructed the patient not to obtain tacrolimus levels for at least one year in the past year.
- The patient does not understand the study procedures. This will be verified by asking the patient to repeat the study procedures.
- The patient is actively psychotic or severely disoriented due to any cause, including hepatic encephalopathy (temporary exclusion) or severe cognitive impairment.
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 |
|---|---|---|
| Behavioral TelehealthThe telemetric intervention (administered via telephone, or interactive video chat applications such as FaceTime ® or Skype ®) will enable the intervention team (IT) to address non-adherence from a remote location, using a structured, tailored approach | Behavioural | Behavioral Telehealth |
Primary outcome
Medication Level Variability Index (MLVI)
Time frame: up to 1 year
The degree of fluctuation of tacrolimus blood levels (calculated as the standard deviation, SD, of tacrolimus).
3 secondary outcomes
Incidence of biopsy-proven rejection
Time frame: up to 1 year
ALT
Time frame: up to 1 year
Incidence of hospitalizations
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2016.
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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.
Eyal Shemesh, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Telehealth in people with Liver Transplant Recipients, run by Icahn School of Medicine at Mount Sinai at 1 site 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?
The sponsor lists 8 inclusion and 6 exclusion criteria. 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: finished, as of the sponsor's last update on 9 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Medication Level Variability Index (MLVI) (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2016; AzTrials last refreshed its copy on 7 Nov 2026.