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Feasibility and success of cell-phone assisted remote observation of medication adherence (CAROMA) in clinical trials.
DeWorsop, David; Creatura, Gina; Bluez, Grai; Thurnauer, Halle; Forselius-Bielen, Kimberlee; Ranganathan, Mohini; Deaso, Emma; Bhat, Jasra Ali; D'Souza, Deepak Cyril.
Afiliación
  • DeWorsop D; 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.
  • Creatura G; 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.
  • Bluez G; 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.
  • Thurnauer H; 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.
  • Forselius-Bielen K; 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.
  • Ranganathan M; 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.
  • Deaso E; 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.
  • Bhat JA; 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.
  • D'Souza DC; 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.
Drug Alcohol Depend ; 163: 24-30, 2016 Jun 01.
Article en En | MEDLINE | ID: mdl-27068252
OBJECTIVE: 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. METHOD: 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. RESULTS: 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. CONCLUSION: 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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Consulta Remota / Cumplimiento de la Medicación / Teléfono Inteligente Tipo de estudio: Clinical_trials Límite: Adolescent / Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Drug Alcohol Depend Año: 2016 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Irlanda
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Consulta Remota / Cumplimiento de la Medicación / Teléfono Inteligente Tipo de estudio: Clinical_trials Límite: Adolescent / Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Drug Alcohol Depend Año: 2016 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Irlanda