Background: Frequent rehospitalisations and poorer survival chances in heart failure (HF) patients may partly be\r\nexplained by poor medication adherence. There are multiple medication-related reasons for suboptimal adherence,\r\nbut psychological reasons may also be important. A novel TELEmonitoring device may improve MEDication\r\nadherence in HF patients (TELEMED-HF). TELEMED-HF is a randomized, controlled clinical intervention trial designed\r\nto examine (1) the efficacy and cost-efficiency of an electronic medication adherence support system in improving\r\nand monitoring HF patients� medication adherence; (2) the effect of medication adherence on hospitalizations and\r\nhealth care consumption; as well as on (3) clinical characteristics, and Quality of Life (QoL); and (4) clinical,\r\nsociodemographic, and psychological determinants of medication adherence.\r\nMethods/Design: Consecutive patients with chronic, systolic HF presenting to the outpatient clinic of the\r\nTweeSteden Hospital, The Netherlands, will be approached for study participation and randomly assigned (1:1)\r\nfollowing blocked randomization procedures to the intervention (n = 200) or usual care arm (n = 200). Patients in\r\nthe intervention arm use the medication support device for six months in addition to usual care. Post-intervention,\r\npatients return to usual care only and all patients participate in four follow-up occasions over 12 months. Primary\r\nendpoints comprise objective and subjective medication adherence, healthcare consumption, number of\r\nhospitalizations, and cost-effectiveness. Secondary endpoints include disease severity, physical functioning, and\r\nQoL.\r\nDiscussion: The TELEMED-HF study will provide us a comprehensive understanding of medication adherence in\r\nHF patients, and will show whether telemonitoring is effective and cost-efficient in improving adherence and\r\npreventing hospitalization in HF patients.\r\nTrial registration number: NCT01347528
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