Investigating a TELEmedicine solution to improve MEDication adherence in chronic Heart Failure (TELEMED-HF): study protocol for a randomized controlled trial
<p>Abstract</p> <p>Background</p> <p>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 re...
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| Format: | Article |
| Language: | English |
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BMC
2011-10-01
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| Series: | Trials |
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| Online Access: | http://www.trialsjournal.com/content/12/1/227 |
| _version_ | 1818385622079897600 |
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| author | Widdershoven Jos Denollet Johan Kessing Dionne Kupper Nina |
| author_facet | Widdershoven Jos Denollet Johan Kessing Dionne Kupper Nina |
| author_sort | Widdershoven Jos |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/Design</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial registration number</p> <p><a href="http://www.clinicaltrials.gov/ct2/show/NCT01347528">NCT01347528</a>.</p> |
| first_indexed | 2024-12-14T03:41:05Z |
| format | Article |
| id | doaj.art-609e153121ca425ca3bfcc35a0889945 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-14T03:41:05Z |
| publishDate | 2011-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-609e153121ca425ca3bfcc35a08899452022-12-21T23:18:29ZengBMCTrials1745-62152011-10-0112122710.1186/1745-6215-12-227Investigating a TELEmedicine solution to improve MEDication adherence in chronic Heart Failure (TELEMED-HF): study protocol for a randomized controlled trialWiddershoven JosDenollet JohanKessing DionneKupper Nina<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/Design</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial registration number</p> <p><a href="http://www.clinicaltrials.gov/ct2/show/NCT01347528">NCT01347528</a>.</p>http://www.trialsjournal.com/content/12/1/227chronic heart failuremedication adherencetelemedicinetelemonitoringintervention trialdeterminants of adherence |
| spellingShingle | Widdershoven Jos Denollet Johan Kessing Dionne Kupper Nina Investigating a TELEmedicine solution to improve MEDication adherence in chronic Heart Failure (TELEMED-HF): study protocol for a randomized controlled trial Trials chronic heart failure medication adherence telemedicine telemonitoring intervention trial determinants of adherence |
| 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 | chronic heart failure medication adherence telemedicine telemonitoring intervention trial determinants of adherence |
| url | http://www.trialsjournal.com/content/12/1/227 |
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