Mental Health DisorderNCT03775044
Assessment of Medherent Medication Management Device and Adherence Platform
A study testing Medherent Device in people with Mental Health Disorder and Medication Adherence, run by Terrapin Pharmacy at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mental Health Disorder, Medication Adherence
- What is being tested?
- Medherent Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 31 Mar 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Under 18 years old.
- Over 80 years old.
- Unable to consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- Measure the effect of the Medherent platform and interventions on adherence and medication use.
- 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.
- 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).
- Measure the effect of Medherent use on clinical outcomes and health service costs.
- 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)
- 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.
- Conditions
- Mental Health Disorder, Medication Adherence
- Being tested
- Medherent Device
- Keywords
- Telemedicine, Medication Adherence, Mental Health Issue
- Medical subject headings
- Mental Disorders, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medherent DeviceDevice
The Medherent Medication Management Device (MMD) is intended to enable patients to self-manage their medication at home when it may otherwise require assistance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Medherent Device | Experimental | All participants get the Medherent device. There is only one arm to this study. Receives: Device: Medherent Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brief Evaluation of Medication Influences and Beliefs (BEMIB) Adherence Measure
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.
Measured: Change between enrollment/baseline and follow up measures (1 month, 6 month, 12 month)
Voils two-part measure of medication nonadherence
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.
Measured: Change between enrollment/baseline and follow up measures (1 month, 6 month, 12 month)
Change in Medication Records
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.
Measured: Change between weekly adherence from enrollment/baseline compared with weekly adherence for the year after receiving the Medherent Machine
Chart review of clinical records for change in level of adherence support
Level of staff medication support including categories. High Support = Mandatory daily supervision, Medium Support = pill count, low support = self-monitoring of medications
Measured: Change level of adherence support from enrollment/baseline compared to adherence support for the year after receiving the Medherent Machine (e.g. Treatment)
Pharmacy interaction outcomes: Refill Times
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.
Measured: Data will be measured continuously for 1 year after receiving the Medherent Machine (e.g. Treatment)
Pharmacy interaction outcomes: Medherent device fail/error rate
Counts of device failures or user interface issues that cause a missed dose. Counts will be of missed doses per installed device
Measured: Data will be measured continuously for 1 year after receiving the Medherent Machine (e.g. Treatment)
Secondary outcomes (2)
Psychiatric Acute Events
Record of psychiatric acute events
Measured: Measured from two years prior to Medherent device installation through 1 year after device installation.
Costs of Services
Medicaid and mental health agency costs data for calculating the cost of service.
Measured: Measured from two years prior to Medherent device installation through 1 year after device installation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start1 May 2019
- Primary completion31 Mar 2022
- Study completion31 Mar 2023 (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 Mental Health DisorderStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Terrapin Pharmacy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Maryland
- Responsible party
- Principal investigator, Joel F. Feldman, Terrapin Pharmacy
- Investigators
- Joel Feldman, JD, Principal investigator, Terrapin Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775044
- Sponsor's protocol ID
- 1R44MH116765-01
- Status last verified
- Oct 2022
- First submitted
- 11 Dec 2018
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De identified participant data for all primary and secondary outcome measures will be made available.
Publications
Unick G, Mattocks N, Yeung CY, Swenson N, Hopkins K, Manleigh C. Medication Dispensing Patterns Among Individuals With Serious Mental Illness Using a Remote Medication Dispensing and Adherence Monitoring Platform: Cohort Study. JMIR Ment Health. 2026 Sep 2;13:e79241. doi: 10.2196/79241.
PubMed 42024272
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Medherent Medication Management Device and Adherence Platform
- ClinicalTrials.gov ID
- NCT03775044
- Acronym / sponsor ID
- 1R44MH116765-01
- Conditions
- Mental Health Disorder, Medication Adherence
- Keywords
- Telemedicine, Medication Adherence, Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Terrapin PharmacyIndustry (pharma, biotech, devices)
- Collaborators
- University of Maryland
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 13 Dec 2018 (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.
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.
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:
- Measure the effect of the Medherent platform and interventions on adherence and medication use.
- 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.
- 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).
- Measure the effect of Medherent use on clinical outcomes and health service costs.
- 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)
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Medherent Device | Experimental | Device: Medherent DeviceAll participants get the Medherent device. There is only one arm to this study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Under 18 years old.
- Over 80 years old.
- Unable to consent to participate in the study.
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 |
|---|---|---|
| Medherent DeviceThe Medherent Medication Management Device (MMD) is intended to enable patients to self-manage their medication at home when it may otherwise require assistance. | Device | Experimental: Medherent Device |
Primary outcome
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.
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.
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.
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
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.
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
2 secondary outcomes
Psychiatric Acute Events
Time frame: Measured from two years prior to Medherent device installation through 1 year after device installation.
Costs of Services
Time frame: Measured from two years prior to Medherent device installation through 1 year after device installation.
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 24 Oct 2022.
- Derived from this study: PubMed 42024272Unick G, Mattocks N, Yeung CY, Swenson N, Hopkins K, Manleigh C. Medication Dispensing Patterns Among Individuals With Serious Mental Illness Using a Remote Medication Dispensing and Adherence Monitoring Platform: Cohort Study. JMIR Ment Health. 2026 Sep 2;13:e79241. doi: 10.2196/79241.
- Individual participant dataSharing planned: Yes. De identified participant data for all primary and secondary outcome measures will be made available.
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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.
Joel Feldman, JD principal investigator
Terrapin Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medherent Device in people with Mental Health Disorder and Medication Adherence, run by Terrapin Pharmacy 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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 24 Oct 2022. 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?
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?
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)). The study lists 6 primary outcomes in all. 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 NCT03775044, 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 24 Oct 2022.