Assessment of Medherent Medication Management Device and Adherence Platform

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Change in Brief Evaluation of Medication Influences and Beliefs (BEMIB) Adherence Measure — 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 — 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 — 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 — 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 — 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 — 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

Trial sites (1)

Other trials for the same condition