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Assessment of Medherent Medication Management Device and Adherence Platform

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775044
Recruitment Status : Active, not recruiting
First Posted : December 13, 2018
Last Update Posted : February 18, 2020
Sponsor:
Collaborator:
University of Maryland, College Park
Information provided by (Responsible Party):
Joel F. Feldman, Terrapin Pharmacy

Brief Summary:
This study uses a stepped wedge designs to estimate the effect of using the Medherent Medication Management Device on medication adherence for a population of 150 individuals who are diagnosed with serious mental illness.

Condition or disease Intervention/treatment Phase
Mental Health Disorder Medication Adherence Device: Medherent Device Not Applicable

Detailed Description:

Individuals suffering from Serious Mental Illnesses (SMI) such as schizophrenia, bipolar disorder or depressive disorders are at risk for serious adverse psychiatric, other health, and social outcomes. Essential to controlling chronic psychiatric and health disorders is adherence to medications that are prescribed to address the symptoms and causes of these health conditions. Medication adherence is particularly challenging for those with SMI. Good adherence is defined as 80% or more of medication taken, whereas the average patient with schizophrenia or bipolar disorder takes 50-70% of prescribed medications. For individuals with SMI, important barriers to adherence include cognitive impairments and lack of illness insight, meaning that they are not aware of the symptoms and consequences of their illness. Inquiries about drug intake by psychiatrists, relatives, or others has been linked to greater adherence. Positive relationships with physicians, psychiatrists and their staff have been found to be significant predictors of good adherence in SMI patients, while difficulties in building a therapeutic alliance and poor clinical-patient relationship are significant predictors of nonadherence. Failure to recognize nonadherence may prompt physicians to misattribute poor outcomes to treatment failure, leading to inappropriate dosage increases or unnecessary medication switches. Moreover, non- adherence in SMI patients is associated with greater economic and social burden, due to higher hospitalization rates, longer hospital stays, more emergency room and emergency psychiatric visits, greater risk of suicide and violence towards others, and higher rates of deleterious psychotic relapses.

The Medherent© Medication Management Device (MMD) is a tool developed by Terrapin Pharmacy to improve medication adherence through the integration of medication dispensing and prompts to consumers to take medications, with real-time electronic feedback to care managers about consumers' adherence behaviors and daily health status. This MMD builds on adherence interventions proven effective in SMI patients and enables care managers to expand the number of individuals that they can care for effectively.

This study uses a stepped-wedge design with 150 individuals across all study sites and approximately 150 individuals to answer the following aims:

  1. Measure the effect of the Medherent platform and interventions on adherence and medication use.

    1. Measure change in adherence by triangulating self-report data, clinician observation, biological measures, chart reviews and clinical outcomes before and after exposure to the Medherent intervention. Medherent device data will also be used to measure the consumer levels of adherence to medications.
    2. Document pharmacy interaction issues (e.g. arranging refill times, responsiveness to prescription changes), device fail rate, and remaining user interface issues (e.g. acceptability of adherence prompts, operating system issues).
  2. Measure the effect of Medherent use on clinical outcomes and health service costs.

    1. Change in clinical relationships, attitudes about medications, and acute care service use (e.g. hospitalizations and emergency department visits) will be measured by consumer interviews, chart reviews, Medherent dispensing data, and claims data (Medicaid)
    2. Using Medicaid data, pharmacy data, and agency clinical data we will develop a cost model for Medherent users before and after enrollment and develop a matched comparison group using other Maryland Medicaid recipients who have not been enrolled in the Medherent treatment arm to measure changes in health service utilization and the corresponding costs.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This study is a stepped wedge design where all individuals receive the intervention but at different time points after enrollment in the study. Each person will have two observations before the intervention and three observations after the intervention. Health service use data will be collected for two years prior to enrollment and two years after enrollment.
Masking: None (Open Label)
Masking Description: No masking is possible for this study.
Primary Purpose: Health Services Research
Official Title: Assessment of Medherent Medication Management Device and Adherence Platform
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Arm Intervention/treatment
Experimental: Experimental: Medherent Device
All participants get the Medherent device. There is only one arm to this study.
Device: Medherent Device
The Medherent Medication Management Device (MMD) is intended to enable patients to self-manage their medication at home when it may otherwise require assistance.




Primary Outcome Measures :
  1. Change in Brief Evaluation of Medication Influences and Beliefs (BEMIB) Adherence Measure [ Time Frame: Change between enrollment/baseline and follow up measures (1 month, 6 month, 12 month) ]
    Brief Evaluation of Medication Influences and Beliefs (BEMIB) is an 8-item scale. Total scores range from 0 to 32 with higher scores indicating more negative beliefs about medications.

  2. Voils two-part measure of medication nonadherence [ Time Frame: Change between enrollment/baseline and follow up measures (1 month, 6 month, 12 month) ]
    Measure of extent of non adherence and reasons for non-adherence The extent of non-adherence scale averages scores over the 3 items and range from 1-5. The measure is continuous with higher scores indicating higher adherence. The reasons for non adherence scale is comprised of 24 reasons for non adherence and are scored individually from 1 to 5 with higher scores indicating more reasons for non adherence.

  3. Change in Medication Records [ Time Frame: Change between weekly adherence from enrollment/baseline compared with weekly adherence for the year after receiving the Medherent Machine ]
    Chart reviews for medication dispensing records and device dispensing data. Data will be combined to create a variable of medication taking behaviors. If an individual had a recorded dose received/dispensed they will be considered to have taken the dose if a dose was not received/dispensed they will be considered to have not taken a dose. Above 80% doses per week will be considered high adherence, 70-79% medium adherence and below 70% low adherence.

  4. Chart review of clinical records for change in level of adherence support [ Time Frame: Change level of adherence support from enrollment/baseline compared to adherence support for the year after receiving the Medherent Machine (e.g. Treatment) ]
    Level of staff medication support including categories. High Support = Mandatory daily supervision, Medium Support = pill count, low support = self-monitoring of medications

  5. Pharmacy interaction outcomes: Refill Times [ Time Frame: Data will be measured continuously for 1 year after receiving the Medherent Machine (e.g. Treatment) ]
    Counts of days with out prescribed medication including days missed due to missed refills or gaps between receipt of prescription changes at the pharmacy till medication is refilled.

  6. Pharmacy interaction outcomes: Medherent device fail/error rate [ Time Frame: Data will be measured continuously for 1 year after receiving the Medherent Machine (e.g. Treatment) ]
    Counts of device failures or user interface issues that cause a missed dose. Counts will be of missed doses per installed device


Secondary Outcome Measures :
  1. Psychiatric Acute Events [ Time Frame: Measured from two years prior to Medherent device installation through 1 year after device installation. ]
    Record of psychiatric acute events

  2. Costs of Services [ Time Frame: Measured from two years prior to Medherent device installation through 1 year after device installation. ]
    Medicaid and mental health agency costs data for calculating the cost of service.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently be a client of a participating community mental health agency
  • Have a diagnoses mental illness
  • Currently be prescribed a psychotropic medication for the purpose of treatment a mental illness
  • Be able to consent to participants in the study
  • Be over 18 years old and under 80 years old

Exclusion Criteria:

  • Under 18 years old.
  • Over 80 years old.
  • Unable to consent to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775044


Locations
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United States, Maryland
Terrapin Pharmacy
Annapolis, Maryland, United States, 21401
Sponsors and Collaborators
Terrapin Pharmacy
University of Maryland, College Park
Investigators
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Principal Investigator: Joel Feldman, JD Terrapin Pharmacy
Additional Information:
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Responsible Party: Joel F. Feldman, President, Terrapin Pharmacy
ClinicalTrials.gov Identifier: NCT03775044    
Other Study ID Numbers: 1R44MH116765-01 ( U.S. NIH Grant/Contract )
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De identified participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Four years after the completion of the study.
Access Criteria: We will make the data and associated documentation available to investigators who are working under an institution with a Federal Wide Assurance (FWA) and who agree to a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) appropriate Intuitional Review Board approval for data use; (3) a commitment to securing the data using appropriate computer technology; and (4) a commitment to destroying or returning the data after analyses are completed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Joel F. Feldman, Terrapin Pharmacy:
Telemedicine
Medication Adherence
Mental Health Issue
Additional relevant MeSH terms:
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Mental Disorders