title: Feasibility and success of cell-phone assisted remote observation of medication adherence (CAROMA) in clinical trials.
abstract: Medication nonadherence is a serious issue in clinical trials, especially in studies of substance abuse disorders. Measuring and confirming adherence is critical to ensuring that collected data is accurate and interpretable. This study evaluated the feasibility and success of a smartphone-based approach (Cellphone Assisted Remote Observation of Medication Adherence [CAROMA]) to visually confirm medication adherence in a clinical trial.
  
  
  
  Medication adherence was confirmed visually via smartphones provided to participants in a double-blind, randomized, placebo-controlled trial for cannabis dependence. Every morning, subjects (n=20) were video-called by staff who observed consumption of study medication. Adherence was also assessed with weekly face-to-face visits, pill counts and plasma drug levels. Subjects were paid for completing daily CAROMA visits, and for returning the smartphone at study completion.
  
  
  
  CAROMA confirmed 96.04% adherence to medication. Concordance between expected and actual remaining study medication counted at weekly study visits was 87.69%. Subjects assigned to active study medication had detectable plasma drug levels, while those assigned to placebo did not. CAROMA was estimated to cost approximately $100 per subject per week - a total of $300.24 per subject for the 3-week outpatient portion of the trial.
  
  
  
  This pilot study demonstrates the feasibility, success and cost-effectiveness of CAROMA to facilitate and confirm medication adherence in a clinical trial. Preliminary findings support larger and longer studies, and possibly applying this approach to clinical care - especially in other populations with high rates of medication nonadherence.
authors.affiliation: Psychiatry Service, VA Connecticut Healthcare System, West Haven, CT, USA; Abraham Ribicoff Research Facilities, Connecticut Mental Health Center, New Haven, CT, USA; Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.
authors.forename: David
authors.initials: D
authors.lastname: DeWorsop
authors.affiliation: Psychiatry Service, VA Connecticut Healthcare System, West Haven, CT, USA; Abraham Ribicoff Research Facilities, Connecticut Mental Health Center, New Haven, CT, USA; Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.
authors.forename: Gina
authors.initials: G
authors.lastname: Creatura
authors.affiliation: Psychiatry Service, VA Connecticut Healthcare System, West Haven, CT, USA; Abraham Ribicoff Research Facilities, Connecticut Mental Health Center, New Haven, CT, USA; Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.
authors.forename: Grai
authors.initials: G
authors.lastname: Bluez
authors.affiliation: Psychiatry Service, VA Connecticut Healthcare System, West Haven, CT, USA; Abraham Ribicoff Research Facilities, Connecticut Mental Health Center, New Haven, CT, USA; Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.
authors.forename: Halle
authors.initials: H
authors.lastname: Thurnauer
authors.affiliation: Psychiatry Service, VA Connecticut Healthcare System, West Haven, CT, USA; Abraham Ribicoff Research Facilities, Connecticut Mental Health Center, New Haven, CT, USA; Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.
authors.forename: Kimberlee
authors.initials: K
authors.lastname: Forselius-Bielen
authors.affiliation: Psychiatry Service, VA Connecticut Healthcare System, West Haven, CT, USA; Abraham Ribicoff Research Facilities, Connecticut Mental Health Center, New Haven, CT, USA; Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.
authors.forename: Mohini
authors.initials: M
authors.lastname: Ranganathan
authors.affiliation: Psychiatry Service, VA Connecticut Healthcare System, West Haven, CT, USA; Abraham Ribicoff Research Facilities, Connecticut Mental Health Center, New Haven, CT, USA; Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.
authors.forename: Emma
authors.initials: E
authors.lastname: Deaso
authors.affiliation: Psychiatry Service, VA Connecticut Healthcare System, West Haven, CT, USA; Abraham Ribicoff Research Facilities, Connecticut Mental Health Center, New Haven, CT, USA; Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.
authors.forename: Jasra Ali
authors.initials: JA
authors.lastname: Bhat
authors.affiliation: Psychiatry Service, VA Connecticut Healthcare System, West Haven, CT, USA; Abraham Ribicoff Research Facilities, Connecticut Mental Health Center, New Haven, CT, USA; Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA. Electronic address: deepak.dsouza@yale.edu.
authors.forename: Deepak Cyril
authors.initials: DC
authors.lastname: D'Souza
mesh_terms: D000293:Adolescent; D000328:Adult; D003362:Cost-Benefit Analysis; D004311:Double-Blind Method; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D002189:Marijuana Abuse / Q000523:psychology / Q000628:therapy; D055118:Medication Adherence / Q000523:psychology*; D008875:Middle Aged; D010865:Pilot Projects; D019114:Remote Consultation / Q000379:methods* / Q000706:statistics & numerical data*; D000068997:Smartphone / Q000706:statistics & numerical data*; D017216:Telemedicine / Q000379:methods / Q000706:statistics & numerical data; D055815:Young Adult
keywords: Clinical trial; Medication; Nonadherence; Noncompliance; Substance abuse; Telehealth; Videocalling