title: A Remote Medication Monitoring System for Chronic Heart Failure Patients to Reduce Readmissions: A Two-Arm Randomized Pilot Study.
abstract: BACKGROUND
  Heart failure (HF) is a chronic condition affecting nearly 5.7 million Americans and is a leading cause of morbidity and mortality. With an aging population, the cost associated with managing HF is expected to more than double from US $31 billion in 2012 to US $70 billion by 2030. Readmission rates for HF patients are high-25% are readmitted at 30 days and nearly 50% at 6 months. Low medication adherence contributes to poor HF management and higher readmission rates. Remote telehealth monitoring programs aimed at improved medication management and adherence may improve HF management and reduce readmissions.
  
  
  OBJECTIVE
  The primary goal of this randomized controlled pilot study is to compare the MedSentry remote medication monitoring system versus usual care in older HF adult patients who recently completed a HF telemonitoring program. We hypothesized that remote medication monitoring would be associated with fewer unplanned hospitalizations and emergency department (ED) visits, increased medication adherence, and improved health-related quality of life (HRQoL) compared to usual care.
  
  
  METHODS
  Participants were randomized to usual care or use of the remote medication monitoring system for 90 days. Twenty-nine participants were enrolled and the final analytic sample consisted of 25 participants. Participants completed questionnaires at enrollment and closeout to gather data on medication adherence, health status, and HRQoL. Electronic medical records were reviewed for data on baseline classification of heart function and the number of unplanned hospitalizations and ED visits during the study period.
  
  
  RESULTS
  Use of the medication monitoring system was associated with an 80% reduction in the risk of all-cause hospitalization and a significant decrease in the number of all-cause hospitalization length of stay in the intervention arm compared to usual care. Objective device data indicated high adherence rates (95%-99%) among intervention group participants despite finding no significant difference in self-reported adherence between study arms. The intervention group had poorer heart function and HRQoL at baseline, and HRQoL declined significantly in the intervention group compared to controls.
  
  
  CONCLUSIONS
  The MedSentry medication monitoring system is a promising technology that merits continued development and evaluation. The MedSentry medication monitoring system may be useful both as a standalone system for patients with complex medication regimens or used to complement existing HF telemonitoring interventions. We found significant reductions in risk of all-cause hospitalization and the number of all-cause length of stay in the intervention group compared to controls. Although HRQoL deteriorated significantly in the intervention group, this may have been due to the poorer HF-functioning at baseline in the intervention group compared to controls. Telehealth medication adherence technologies, such as the MedSentry medication monitoring system, are a promising method to improve patient self-management,the quality of patient care, and reduce health care utilization and expenditure for patients with HF and other chronic diseases that require complex medication regimens.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01814696; https://clinicaltrials.gov/ct2/show/study/NCT01814696 (Archived by WebCite® at http://www.webcitation.org/6giqAVhno).
authors.affiliation: Partners Healthcare, Connected Health, Boston, MA, United States. tmhale@mgh.harvard.edu.
authors.forename: Timothy M
authors.identifier: http://orcid.org/0000-0002-4228-465X
authors.initials: TM
authors.lastname: Hale
authors.forename: Kamal
authors.identifier: http://orcid.org/0000-0002-0122-8002
authors.initials: K
authors.lastname: Jethwani
authors.forename: Manjinder Singh
authors.identifier: http://orcid.org/0000-0002-1097-5050
authors.initials: MS
authors.lastname: Kandola
authors.forename: Fidencio
authors.identifier: http://orcid.org/0000-0003-1857-0848
authors.initials: F
authors.lastname: Saldana
authors.forename: Joseph C
authors.identifier: http://orcid.org/0000-0002-7517-2291
authors.initials: JC
authors.lastname: Kvedar
mesh_terms: D000368:Aged; D002908:Chronic Disease; D004636:Emergency Service, Hospital; D005260:Female; D006304:Health Status; D006333:Heart Failure / Q000188:drug therapy* / Q000517:prevention & control*; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008991:Monitoring, Physiologic / Q000379:methods; D010359:Patient Readmission; D010865:Pilot Projects; D011788:Quality of Life; D012107:Research Design; D012648:Self Care; D011795:Surveys and Questionnaires; D017216:Telemedicine / Q000379:methods*
keywords: ED visits; complex medication regimens; heart failure; hospitalization length of stay; medication adherence; medication management; self-care; self-management; telehealth; telemonitoring