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Investigating a TELEmedicine solution to improve MEDication adherence in chronic Heart Failure (TELEMED-HF): study protocol for a randomized controlled trial
BACKGROUND: Frequent 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 dev...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2011
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3213026/ https://www.ncbi.nlm.nih.gov/pubmed/21999637 http://dx.doi.org/10.1186/1745-6215-12-227 |
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author | Kessing, Dionne Denollet, Johan Widdershoven, Jos Kupper, Nina |
author_facet | Kessing, Dionne Denollet, Johan Widdershoven, Jos Kupper, Nina |
author_sort | Kessing, Dionne |
collection | PubMed |
description | BACKGROUND: Frequent 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/DESIGN: Consecutive 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. DISCUSSION: The 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 NUMBER: NCT01347528. |
format | Online Article Text |
id | pubmed-3213026 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2011 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-32130262011-11-11 Investigating a TELEmedicine solution to improve MEDication adherence in chronic Heart Failure (TELEMED-HF): study protocol for a randomized controlled trial Kessing, Dionne Denollet, Johan Widdershoven, Jos Kupper, Nina Trials Study Protocol BACKGROUND: Frequent 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/DESIGN: Consecutive 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. DISCUSSION: The 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 NUMBER: NCT01347528. BioMed Central 2011-10-14 /pmc/articles/PMC3213026/ /pubmed/21999637 http://dx.doi.org/10.1186/1745-6215-12-227 Text en Copyright ©2011 Kessing et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Study Protocol Kessing, Dionne Denollet, Johan Widdershoven, Jos Kupper, Nina Investigating a TELEmedicine solution to improve MEDication adherence in chronic Heart Failure (TELEMED-HF): study protocol for a randomized controlled trial |
title | Investigating a TELEmedicine solution to improve MEDication adherence in chronic Heart Failure (TELEMED-HF): study protocol for a randomized controlled trial |
title_full | Investigating a TELEmedicine solution to improve MEDication adherence in chronic Heart Failure (TELEMED-HF): study protocol for a randomized controlled trial |
title_fullStr | Investigating a TELEmedicine solution to improve MEDication adherence in chronic Heart Failure (TELEMED-HF): study protocol for a randomized controlled trial |
title_full_unstemmed | Investigating a TELEmedicine solution to improve MEDication adherence in chronic Heart Failure (TELEMED-HF): study protocol for a randomized controlled trial |
title_short | Investigating a TELEmedicine solution to improve MEDication adherence in chronic Heart Failure (TELEMED-HF): study protocol for a randomized controlled trial |
title_sort | investigating a telemedicine solution to improve medication adherence in chronic heart failure (telemed-hf): study protocol for a randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3213026/ https://www.ncbi.nlm.nih.gov/pubmed/21999637 http://dx.doi.org/10.1186/1745-6215-12-227 |
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