NonadherencePhase 1I-AMNCT01960322
Improving Medication-taking After Liver Transplant
A Phase 1 study testing Telemetric in people with Nonadherence and Tacrolimus, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
Trial summary
The specific aim is to pilot-test our developed intervention manual's ability to improve patients' adherence to medications and medical outcomes (rejection rate, liver enzyme levels) in participating centers. Read more about this study
- Who is it for?
- Ages 11 to 19 years
- Conditions the study is for
- Nonadherence, Tacrolimus, Pediatric Liver Transplant Recipients
- What is being tested?
- Telemetric
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2014to May 2016
- Phase
- Phase 1
- 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 11 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The patient is between 11-19 years of age at enrollment.
- Guardian's consent, child assent (in accordance with each institution's IRB policies).
- The patient is prescribed tacrolimus (either brand or generic formulation).
- The patient has been seen in the enrolling center's clinic at least once in the last two years.
- The patient's SD of tacrolimus was > 2.0 in the year prior to enrollment, with at least 3 levels present to make this determination.
- The patient and at least one guardian speaks English or Spanish at a level that allows her / him to understand the study procedures and consent to the study.
Who cannot join
- The patient received a liver transplant less than 1 year prior to enrollment.
- The patient has had more than one transplant (including marrow replacement).
- The patient has had biopsy-proven rejection within the past six months.
- The patient has been diagnosed with Hepatitis C.
- The treating physician has instructed the patient not to obtain tacrolimus levels for at least one year in the past year.
- The guardian or child (in a developmentally-appropriate manner) do not understand the study procedures. This will be verified by asking both guardian and child to repeat the study procedures.
Show all 9Show fewer
- The patient is only seen for consultation - most or all of the child's routine care is provided at another center (or in a community clinic).
- Either the patient or the guardian is actively psychotic or severely disoriented due to any cause, including hepatic encephalopathy (temporary exclusion) or severely mentally retarded as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV).
- The patient is not medically stable or is hospitalized.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
UCLA Mattell Children's Hospital
Los Angeles, California, 90095
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
Official title: Intervention After MALT (I-AM): Feasibility of Improving Adherence Among Pediatric and Adult Cardiac Transplant Patients Using a Telemetric Intervention
The specific aim is to pilot-test our developed intervention manual's ability to improve patients' adherence to medications and medical outcomes (rejection rate, liver enzyme levels) in participating centers.
Read the detailed description
Nonadherence (not taking the medications as prescribed) is the most common cause of late acute rejection in children who have had a liver transplant, and thus is associated with graft loss, increased expenditures on care, and ultimately death. Researchers in this application developed a biomarker to identify nonadherence, calculating the standard deviation (SD) of consecutive immunosuppressant blood levels for each patient to capture the degree of variability between individual levels (higher SD = less consistent levels). By applying a threshold, this marker identifies nonadherent patients. A consortium of transplant centers is currently testing this marker through the MALT (Medication Adherence in children who had a Liver Transplant) study. MALT investigators now propose to take advantage of this existing collaboration to pilot-test an intervention to improve adherence in patients who are identified by this marker.
- Being tested
- Telemetric
- Keywords
- adherence, nonadherence, compliance, noncompliance, liver transplantation
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemetricBehavioural
A manualized behavioral management approach focusing on avoidance and addressing barriers to adherence, delivered via telephone or internet chat applications.
| Study group | Role | What they receive |
|---|---|---|
| Telemetric | Experimental | Enrolled patients will be followed for 12 months during which they will receive the study telemetry intervention. Receives: Behavioral: Telemetric |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adherence
Change in Adherence at one year compared to at baseline measured via the Standard Deviation of Tacrolimus levels obtained
Measured: at baseline and one year
Secondary outcomes (4)
Change in Incidence of rejection
Change in Incidence of rejection compared at one year to baseline
Measured: at baseline and at one year
Liver Enzyme Levels
Measured: at baseline
Liver Enzyme Levels
Measured: at one year
Feasibility
Participation in the intervention (receive all of the remote interactions called for in the manual, presented as a percentage of received / offered during the intervention active phase, 1 year)
Measured: at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startAug 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NonadherenceStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, Children's Hospital Medical Center, Cincinnati, University of Pittsburgh, The Emmes Company, LLC
- Responsible party
- Sponsor
- Investigators
- Eyal Shemesh, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960322
- Sponsor's protocol ID
- GCO 13-0223
- Acronym
- I-AM
- Status last verified
- Jun 2016
- First submitted
- 8 Oct 2013
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention After MALT (I-AM): Feasibility of Improving Adherence Among Pediatric and Adult Cardiac Transplant Patients Using a Telemetric Intervention
- ClinicalTrials.gov ID
- NCT01960322
- Acronym / sponsor ID
- I-AM / GCO 13-0223
- Keywords
- adherence, nonadherence, compliance, noncompliance, liver transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, Children's Hospital Medical Center, Cincinnati, University of Pittsburgh, The Emmes Company, LLC
- Study start
- Aug 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 10 Oct 2013 (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 specific aim is to pilot-test our developed intervention manual's ability to improve patients' adherence to medications and medical outcomes (rejection rate, liver enzyme levels) in participating centers.
Detailed description
Nonadherence (not taking the medications as prescribed) is the most common cause of late acute rejection in children who have had a liver transplant, and thus is associated with graft loss, increased expenditures on care, and ultimately death. Researchers in this application developed a biomarker to identify nonadherence, calculating the standard deviation (SD) of consecutive immunosuppressant blood levels for each patient to capture the degree of variability between individual levels (higher SD = less consistent levels). By applying a threshold, this marker identifies nonadherent patients. A consortium of transplant centers is currently testing this marker through the MALT (Medication Adherence in children who had a Liver Transplant) study. MALT investigators now propose to take advantage of this existing collaboration to pilot-test an intervention to improve adherence in patients who are identified by this marker.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telemetric | Experimental | Behavioral: TelemetricEnrolled patients will be followed for 12 months during which they will receive the study telemetry intervention. |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- The patient is between 11-19 years of age at enrollment.
- Guardian's consent, child assent (in accordance with each institution's IRB policies).
- The patient is prescribed tacrolimus (either brand or generic formulation).
- The patient has been seen in the enrolling center's clinic at least once in the last two years.
- The patient's SD of tacrolimus was > 2.0 in the year prior to enrollment, with at least 3 levels present to make this determination.
Key exclusion criteria (9 listed)
- The patient received a liver transplant less than 1 year prior to enrollment.
- The patient has had more than one transplant (including marrow replacement).
- The patient has had biopsy-proven rejection within the past six months.
- The patient has been diagnosed with Hepatitis C.
- The treating physician has instructed the patient not to obtain tacrolimus levels for at least one year in the past year.
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 |
|---|---|---|
| TelemetricA manualized behavioral management approach focusing on avoidance and addressing barriers to adherence, delivered via telephone or internet chat applications. | Behavioural | Telemetric |
Primary outcome
Change in Adherence
Time frame: at baseline and one year
Change in Adherence at one year compared to at baseline measured via the Standard Deviation of Tacrolimus levels obtained
4 secondary outcomes
Change in Incidence of rejection
Time frame: at baseline and at one year
Liver Enzyme Levels
Time frame: at baseline
Liver Enzyme Levels
Time frame: at one year
Feasibility
Time frame: at one 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 1 Jul 2016.
Related trials for Nonadherence
Not yet recruiting
Digital Outreach for Heart Failure Adherence
CHF - Congestive Heart Failure
Active, not recruiting
Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant
Transplant;Failure,Kidney, Transplant; Failure, Liver
Active, not recruitingPhase 1/2
Symptom-driven ICS/LABA Therapy for Patients With Asthma Non-adherent to Daily Maintenance Inhalers
Asthma, Nonadherence, Medication
Recruiting
Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients
Heart Transplant Rejection, Immune Suppression
Enrolling by invitation
Evaluating Urine Isoniazid Testing to Detect Nonadherence to Tuberculosis Medications in India
Tuberculosis, Pulmonary, Medication Adherence
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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Telemetric in people with Nonadherence and Tacrolimus, run by Icahn School of Medicine at Mount Sinai 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?
The sponsor lists 6 inclusion and 9 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 1 Jul 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Adherence (time frame: at baseline and one 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 1 Jul 2016.