title: Rationale and design of the Randomized Evaluation to Measure Improvements in Non-adherence from Low-Cost Devices (REMIND) trial.
abstract: BACKGROUND
  Long-term adherence to prescription medications for the treatment of chronic disease remains low. While there are many contributors to suboptimal medication use, simple forgetfulness is widely believed to be central. Relatively simple devices may be a particularly cost-efficient and scalable way to promote adherence, however limited data exists about their ability to improve adherence in real-world settings.
  
  
  METHODS
  The REMIND trial is a prospective, intent-to-treat randomized control trial to evaluate the impact on medication adherence of three simple, low-cost devices (Take-N-Slide(™), the RxTimerCap(™), and a standard pillbox). In March 2014, we enrolled 53,480 individuals 18 to 64 years old taking one to three medications to treat chronic disease whose prescription drug benefits were administered by CVS Caremark. The study's primary outcome is optimal adherence over the 12-month period after randomization. Using a randomization ratio of 1:2 between control and each intervention arm, the study has more than 80% power with an alpha of 5% to detect a 1% difference in the rate of optimal adherence between intervention and control groups and across intervention arms.
  
  
  CONCLUSIONS
  The REMIND trial is the first randomized study to rigorously evaluate the impact of simple, low-cost reminder devices on medication adherence. The results will inform comparative cost effectiveness studies of reminder systems in improving medication adherence and clinical outcomes.
authors.affiliation: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA 02120, United States. Electronic address: nchoudhry@partners.org.
authors.forename: Niteesh K
authors.initials: NK
authors.lastname: Choudhry
authors.affiliation: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA 02120, United States. Electronic address: akrumme@partners.org.
authors.forename: Alexis A
authors.initials: AA
authors.lastname: Krumme
authors.affiliation: CVS Health, One CVS Drive, Woonsocket, RI 02895, United States. Electronic address: patrick.ercole@CVSCaremark.com.
authors.forename: Patrick M
authors.initials: PM
authors.lastname: Ercole
authors.affiliation: CVS Health, One CVS Drive, Woonsocket, RI 02895, United States. Electronic address: charmaine.girdish@CVSCaremark.com.
authors.forename: Charmaine
authors.initials: C
authors.lastname: Girdish
authors.affiliation: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA 02120, United States. Electronic address: disaman@partners.org.
authors.forename: Danielle L
authors.initials: DL
authors.lastname: Isaman
authors.affiliation: CVS Health, One CVS Drive, Woonsocket, RI 02895, United States. Electronic address: olga.matlin@CVSHealth.com.
authors.forename: Olga S
authors.initials: OS
authors.lastname: Matlin
authors.affiliation: CVS Health, One CVS Drive, Woonsocket, RI 02895, United States. Electronic address: troyen.brennan@CVSHealth.com.
authors.forename: Troyen A
authors.initials: TA
authors.lastname: Brennan
authors.affiliation: CVS Health, One CVS Drive, Woonsocket, RI 02895, United States. Electronic address: william.shrank@CVSHealth.com.
authors.forename: William H
authors.initials: WH
authors.lastname: Shrank
authors.affiliation: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA 02120, United States. Electronic address: jmfranklin@partners.org.
authors.forename: Jessica M
authors.initials: JM
authors.lastname: Franklin
mesh_terms: D000293:Adolescent; D000328:Adult; D002908:Chronic Disease / Q000188:drug therapy*; D003362:Cost-Benefit Analysis; D005260:Female; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D011446:Prospective Studies; D017010:Reminder Systems / Q000191:economics* / Q000295:instrumentation*; D012107:Research Design; D055815:Young Adult
keywords: Cardiovascular disease; Low-cost reminder system; Medication adherence