Assessment of Medherent Medication Management Device and Adherence Platform

NCT03775044 | Active Not Recruiting FDA Device

• 1 other identifier: 1R44MH116765-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Disorder; Medication Adherence

Keywords

Telemedicine; Medication Adherence; Mental Health Issue

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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

  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.

  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

  Data will be measured continuously for 1 year after receiving the Medherent Machine (e.g. Treatment)

Secondary Outcomes (2)

• Psychiatric Acute Events

  Measured from two years prior to Medherent device installation through 1 year after device installation.

• Costs of Services

  Measured from two years prior to Medherent device installation through 1 year after device installation.

Study Arms (1)

Experimental: Medherent Device

EXPERIMENTAL

All participants get the Medherent device. There is only one arm to this study.

Device: Medherent Device

Interventions

Medherent Device 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.

Experimental: Medherent Device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Terrapin Pharmacy: lead
• University of Maryland: collaborator

Study Sites (1)

Terrapin Pharmacy

Annapolis, Maryland, 21401, United States

Location

MeSH Terms

Conditions

Mental Disorders; Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Joel Feldman, JD

  Terrapin Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking is possible for this study.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Model Details: 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.

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 13, 2018
• Study Start: May 1, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2023
• Last Updated: October 24, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (1)