Abstract
BackgroundFrequent rehospitalisations and poorer survival chances in heart failure (HF) patients may partly be explained by poor medication adherence. There are multiple medication-related reasons for suboptimal adherence, but psychological reasons may also be important. A novel TELEmonitoring device may improve MEDication adherence in HF patients (TELEMED-HF). TELEMED-HF is a randomized, controlled clinical intervention trial designed to examine (1) the efficacy and cost-efficiency of an electronic medication adherence support system in improving and monitoring HF patients' medication adherence; (2) the effect of medication adherence on hospitalizations and health care consumption; as well as on (3) clinical characteristics, and Quality of Life (QoL); and (4) clinical, sociodemographic, and psychological determinants of medication adherence.Methods/DesignConsecutive patients with chronic, systolic HF presenting to the outpatient clinic of the TweeSteden Hospital, The Netherlands, will be approached for study participation and randomly assigned (1:1) following blocked randomization procedures to the intervention (n = 200) or usual care arm (n = 200). Patients in the intervention arm use the medication support device for six months in addition to usual care. Post-intervention, patients return to usual care only and all patients participate in four follow-up occasions over 12 months. Primary endpoints comprise objective and subjective medication adherence, healthcare consumption, number of hospitalizations, and cost-effectiveness. Secondary endpoints include disease severity, physical functioning, and QoL.DiscussionThe TELEMED-HF study will provide us a comprehensive understanding of medication adherence in HF patients, and will show whether telemonitoring is effective and cost-efficient in improving adherence and preventing hospitalization in HF patients.Trial registration numberNCT01347528.
Highlights
Frequent rehospitalisations and poorer survival chances in heart failure (HF) patients may partly be explained by poor medication adherence
Statistical analysis This trial is designed to show whether the Medication Adherence Support System (MASS) device is effective in improving medication adherence in a chronic HF population compared to usual care only
A few major clinical trials have used strategies consisting of daily telemonitoring of symptoms and health behaviors in HF patients [13,14]
Summary
The TELEMED-HF study is designed to test the efficacy and cost-efficiency of an innovative telemonitoring solution, the MASS device, in improving medication adherence as compared to usual care alone in a large group of HF patients. Most studies did not examine the effect of telemonitoring on longer term outcomes past 6 months, nor the clinical course of HF [12] This RCT is designed to determine the effect of medication adherence on the clinical state, disease progression, health care consumption, and QoL with a follow-up period of one year. The results of the TELEMED-HF study are expected (a) to provide us a comprehensive understanding of medication adherence in HF patients, (b) to indicate whether the MASS device is effective and cost-efficient in improving medication adherence and preventing hospitalization in HF patients, and (c) to identify which subgroups of HF patients may benefit most from MASS. List of abbreviations HF: heart failure; MASS: Medication adherence support system; QoL: Quality of life
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
