Robust Evaluation to Measure Improvements in Nonadherence From Low-cost Devices
Condition: Cardiovascular Disease; Diabetes; Breast Cancer; Depression; Mental Health Disorder; Prostatic Hypertrophy, Benign; Parkinson's Disease; Epilepsy
MeSH terms: Parkinson Disease; Prostatic Hyperplasia; Cardiovascular Diseases; Hypertrophy; Mental Disorders
Study type: Interventional

Summary: 
      The aim of this study is to determine whether adherence to oral maintenance medications
      differs for patients randomized to receive a RxTimerCap, a Take-N-Slide, a standard pillbox,
      or none of these devices, with the hypothesis that low-touch devices improve adherence over
      control and that the increase in adherence is agnostic across devices.
    

Detailed description: 
      Prior to randomization, all patients meeting the inclusion criteria stratified into two
      strata and two blocks within each strata. The first stratum will consist of all patients on 1
      to 3 medications for cardiovascular or other non-depression chronic conditions who are
      suboptimally adherent to these therapies. The second stratum will include all patients whose
      only targeted medications are for depression and who are suboptimally adherent to this
      therapy. Given that the Take-N-Slide device only has a Yes/No toggle for each day of the week
      and can therefore only be used once per day, each stratum will be further stratified into two
      separate blocks based on the frequency with which the study participants' medications are (or
      could possibly be) taken. Patients who are on a medication that is used more than once daily
      will be randomized in a 2:1 ratio to receive the RxTimerCap, pillbox, or to continue with
      usual care. Patients for whom all medications are dosed once daily will be randomized in a
      2:1 ratio to receive the Take-N-Slide, RxTimerCap, pillbox, or to continue with usual care.
    

Intervention name(s): RxTimerCap; Take-N-Slide; Pillbox
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The RxTimerCap is a pill bottle cap with a digital timer that shows the time elapsed since the medication was last taken. Patients randomized to receive the RxTimerCap will receive a one-time mailing with one device for each of the maintenance medications they were using at the time of identification for study eligibility; additionally, patients will receive an information card explaining the device's use which includes a telephone number at which they can get additional information.; The Take-N-Slide device is a patented strip with toggles for each day of the week which are meant to be slid after taking a medication. Each Take-N-Slide can be removed and reused for the next prescription bottle. Patients randomized to receive Take-N-Slide will receive a one-time mailing with one device for each of the maintenance medications they were using at the time of identification for study eligibility; additionally, patients will receive an information card explaining the device's use which includes a telephone number at which they can get additional information.; The standard pillbox is a plastic organization box with one compartment for every day of the week. Patients randomized to receive a pillbox will receive a one-time mailing with one device for each of the maintenance medications they were using at the time of identification for study eligibility; additionally, patients will receive an information card explaining the device's use which includes a telephone number at which they can get additional information.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Quality improvement; Randomized controlled trial; Medication adherence; RxTimer Cap; PillMinder; Take-N-Slide; Low-touch devices; Medication management