Lifestyle and Treatment Adherence Intervention after a Coronary Event Based on an Interactive Web Application (EVITE): Randomized Controlled Clinical Trial Protocol
Coronary heart disease is one of the main causes of morbimortality around the world. Patients that survive a coronary event suffer a high risk of readmission, relapse and mortality, attributed to the sub-optimal control of cardiovascular risk factors (CVRF), which highlights the need to improve seco...
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creator | Bernal-Jiménez, María Ángeles Calle-Pérez, Germán Gutiérrez-Barrios, Alejandro Gheorghe, Livia Solano-Mulero, Ana María Rodríguez-Martín, Amelia Tur, Josep A Vázquez-García, Rafael Santi-Cano, María José |
description | Coronary heart disease is one of the main causes of morbimortality around the world. Patients that survive a coronary event suffer a high risk of readmission, relapse and mortality, attributed to the sub-optimal control of cardiovascular risk factors (CVRF), which highlights the need to improve secondary prevention strategies aimed at improving their lifestyle and adherence to treatment. Through a randomized controlled clinical trial, this study aims to evaluate the effect of an intervention involving an online health application supported by a mobile telephone or tablet (mHealth) on lifestyle (diet, physical activity, and tobacco consumption) and treatment adherence among people with coronary heart disease after percutaneous coronary intervention. The sample will comprise 240 subjects (120 in each arm: intervention and usual care). They are assessed immediately and nine months after their hospital discharge about sociodemographic, clinical, CVRF, lifestyle, and treatment adherence characteristics. The educative intervention, involving a follow-up and self-monitoring, will be performed using an online mHealth tool consisting of an application for mobile phones and tablets. The quantitative primary outcomes from the two groups will be compared using an analysis of covariance (ANCOVA) adjusted for age and gender. A multivariate analysis will be performed to examine the association of the intervention with lifestyle habits, the control of CVRFs, and outcomes after discharge in terms of the use of health services, emergency visits, cardiovascular events and readmissions. |
doi_str_mv | 10.3390/nu13061818 |
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Patients that survive a coronary event suffer a high risk of readmission, relapse and mortality, attributed to the sub-optimal control of cardiovascular risk factors (CVRF), which highlights the need to improve secondary prevention strategies aimed at improving their lifestyle and adherence to treatment. Through a randomized controlled clinical trial, this study aims to evaluate the effect of an intervention involving an online health application supported by a mobile telephone or tablet (mHealth) on lifestyle (diet, physical activity, and tobacco consumption) and treatment adherence among people with coronary heart disease after percutaneous coronary intervention. The sample will comprise 240 subjects (120 in each arm: intervention and usual care). They are assessed immediately and nine months after their hospital discharge about sociodemographic, clinical, CVRF, lifestyle, and treatment adherence characteristics. The educative intervention, involving a follow-up and self-monitoring, will be performed using an online mHealth tool consisting of an application for mobile phones and tablets. The quantitative primary outcomes from the two groups will be compared using an analysis of covariance (ANCOVA) adjusted for age and gender. A multivariate analysis will be performed to examine the association of the intervention with lifestyle habits, the control of CVRFs, and outcomes after discharge in terms of the use of health services, emergency visits, cardiovascular events and readmissions.</description><identifier>ISSN: 2072-6643</identifier><identifier>EISSN: 2072-6643</identifier><identifier>DOI: 10.3390/nu13061818</identifier><identifier>PMID: 34071782</identifier><language>eng</language><publisher>Switzerland: MDPI AG</publisher><subject>Angioplasty ; Applications programs ; Cardiac patients ; Cardiovascular disease ; Cardiovascular diseases ; Cardiovascular system ; Cell Phone ; Cell phones ; Cellular telephones ; Clinical outcomes ; Clinical trials ; Coronary artery disease ; Coronary Disease - prevention & control ; Coronary Disease - therapy ; Coronary heart disease ; Diet ; Disease prevention ; Exercise ; Health aspects ; Health risks ; Health services ; Heart ; Heart diseases ; Hospitals ; Humans ; Interactive control ; Internet ; Internet access ; Intervention ; Life Style ; Lifestyles ; Medical personnel ; Medical research ; Medicine, Experimental ; Mobile Applications ; Multivariate analysis ; Optimal control ; Patient compliance ; Physical activity ; Product development ; Risk analysis ; Risk factors ; Risk management ; Secondary Prevention - methods ; Smartphones ; Telemedicine - methods ; Text Messaging ; Tobacco ; Transluminal angioplasty ; Treatment Adherence and Compliance</subject><ispartof>Nutrients, 2021-05, Vol.13 (6), p.1818</ispartof><rights>COPYRIGHT 2021 MDPI AG</rights><rights>2021 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2021 by the authors. 2021</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c473t-83c01fed0ff435613ae8c1bbf8fa855e371eb3688cbcf07bfc16e4f65a5e4df13</citedby><cites>FETCH-LOGICAL-c473t-83c01fed0ff435613ae8c1bbf8fa855e371eb3688cbcf07bfc16e4f65a5e4df13</cites><orcidid>0000-0002-4430-6031 ; 0000-0002-6940-0761 ; 0000-0003-1445-0478 ; 0000-0001-8876-474X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8226528/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8226528/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,27901,27902,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34071782$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bernal-Jiménez, María Ángeles</creatorcontrib><creatorcontrib>Calle-Pérez, Germán</creatorcontrib><creatorcontrib>Gutiérrez-Barrios, Alejandro</creatorcontrib><creatorcontrib>Gheorghe, Livia</creatorcontrib><creatorcontrib>Solano-Mulero, Ana María</creatorcontrib><creatorcontrib>Rodríguez-Martín, Amelia</creatorcontrib><creatorcontrib>Tur, Josep A</creatorcontrib><creatorcontrib>Vázquez-García, Rafael</creatorcontrib><creatorcontrib>Santi-Cano, María José</creatorcontrib><title>Lifestyle and Treatment Adherence Intervention after a Coronary Event Based on an Interactive Web Application (EVITE): Randomized Controlled Clinical Trial Protocol</title><title>Nutrients</title><addtitle>Nutrients</addtitle><description>Coronary heart disease is one of the main causes of morbimortality around the world. Patients that survive a coronary event suffer a high risk of readmission, relapse and mortality, attributed to the sub-optimal control of cardiovascular risk factors (CVRF), which highlights the need to improve secondary prevention strategies aimed at improving their lifestyle and adherence to treatment. Through a randomized controlled clinical trial, this study aims to evaluate the effect of an intervention involving an online health application supported by a mobile telephone or tablet (mHealth) on lifestyle (diet, physical activity, and tobacco consumption) and treatment adherence among people with coronary heart disease after percutaneous coronary intervention. The sample will comprise 240 subjects (120 in each arm: intervention and usual care). They are assessed immediately and nine months after their hospital discharge about sociodemographic, clinical, CVRF, lifestyle, and treatment adherence characteristics. The educative intervention, involving a follow-up and self-monitoring, will be performed using an online mHealth tool consisting of an application for mobile phones and tablets. The quantitative primary outcomes from the two groups will be compared using an analysis of covariance (ANCOVA) adjusted for age and gender. A multivariate analysis will be performed to examine the association of the intervention with lifestyle habits, the control of CVRFs, and outcomes after discharge in terms of the use of health services, emergency visits, cardiovascular events and readmissions.</description><subject>Angioplasty</subject><subject>Applications programs</subject><subject>Cardiac patients</subject><subject>Cardiovascular disease</subject><subject>Cardiovascular diseases</subject><subject>Cardiovascular system</subject><subject>Cell Phone</subject><subject>Cell phones</subject><subject>Cellular telephones</subject><subject>Clinical outcomes</subject><subject>Clinical trials</subject><subject>Coronary artery disease</subject><subject>Coronary Disease - prevention & control</subject><subject>Coronary Disease - therapy</subject><subject>Coronary heart disease</subject><subject>Diet</subject><subject>Disease prevention</subject><subject>Exercise</subject><subject>Health aspects</subject><subject>Health risks</subject><subject>Health services</subject><subject>Heart</subject><subject>Heart diseases</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Interactive control</subject><subject>Internet</subject><subject>Internet access</subject><subject>Intervention</subject><subject>Life Style</subject><subject>Lifestyles</subject><subject>Medical personnel</subject><subject>Medical research</subject><subject>Medicine, Experimental</subject><subject>Mobile Applications</subject><subject>Multivariate analysis</subject><subject>Optimal control</subject><subject>Patient compliance</subject><subject>Physical activity</subject><subject>Product development</subject><subject>Risk analysis</subject><subject>Risk factors</subject><subject>Risk management</subject><subject>Secondary Prevention - methods</subject><subject>Smartphones</subject><subject>Telemedicine - methods</subject><subject>Text Messaging</subject><subject>Tobacco</subject><subject>Transluminal angioplasty</subject><subject>Treatment Adherence and Compliance</subject><issn>2072-6643</issn><issn>2072-6643</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNptUm1rHCEQXkpDE9J86Q8oQr-khUt0ddXrh8L1uLYHBynl2n4U1x0Tg6sXd_cg-T35oXV7eS1V0HHmeeZxhimKNwSfUDrFp2EgFHMiiXxRHJRYlBPOGX35xN4vjrruEo9LYMHpq2KfMiyIkOVBcbtyFrr-2gPSoUHrBLpvIfRo1lxAgmAALUMPaZt9LgakbX4gjeYxxaDTNVqMEfRZd9CgMR52eG16twX0G2o022y8M_ov_Xjxa7levP-IfmS12LqbzJrH0Kfo_Wh6FzLU53-4fH5PsY8m-tfFntW-g6O7-7D4-WWxnn-brM6-Luez1cQwQfuJpAYTCw22ltGKE6pBGlLXVlotqwqoIFBTLqWpjcWitoZwYJZXugLWWEIPi0-7vJuhbqExubKkvdok1-ZSVdROPY8Ed6HO41bJsuRVKXOC47sEKV4Nua-qdZ0B73WAOHSqrChnnPPpqPXuH-hlHFLI5WUUY9NyWnLxiDrXHpQLNmZdMyZVM8EryQWuRtmT_6DybqB1JgawLvufET7sCCbFrktgH2okWI1jpR7HKoPfPu3KA_R-iOgfvyPJcw</recordid><startdate>20210527</startdate><enddate>20210527</enddate><creator>Bernal-Jiménez, María Ángeles</creator><creator>Calle-Pérez, Germán</creator><creator>Gutiérrez-Barrios, Alejandro</creator><creator>Gheorghe, Livia</creator><creator>Solano-Mulero, Ana María</creator><creator>Rodríguez-Martín, Amelia</creator><creator>Tur, Josep A</creator><creator>Vázquez-García, Rafael</creator><creator>Santi-Cano, María José</creator><general>MDPI AG</general><general>MDPI</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-4430-6031</orcidid><orcidid>https://orcid.org/0000-0002-6940-0761</orcidid><orcidid>https://orcid.org/0000-0003-1445-0478</orcidid><orcidid>https://orcid.org/0000-0001-8876-474X</orcidid></search><sort><creationdate>20210527</creationdate><title>Lifestyle and Treatment Adherence Intervention after a Coronary Event Based on an Interactive Web Application (EVITE): Randomized Controlled Clinical Trial Protocol</title><author>Bernal-Jiménez, María Ángeles ; Calle-Pérez, Germán ; Gutiérrez-Barrios, Alejandro ; Gheorghe, Livia ; Solano-Mulero, Ana María ; Rodríguez-Martín, Amelia ; Tur, Josep A ; Vázquez-García, Rafael ; Santi-Cano, María José</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c473t-83c01fed0ff435613ae8c1bbf8fa855e371eb3688cbcf07bfc16e4f65a5e4df13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Angioplasty</topic><topic>Applications programs</topic><topic>Cardiac patients</topic><topic>Cardiovascular disease</topic><topic>Cardiovascular diseases</topic><topic>Cardiovascular system</topic><topic>Cell Phone</topic><topic>Cell phones</topic><topic>Cellular telephones</topic><topic>Clinical outcomes</topic><topic>Clinical trials</topic><topic>Coronary artery disease</topic><topic>Coronary Disease - 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Patients that survive a coronary event suffer a high risk of readmission, relapse and mortality, attributed to the sub-optimal control of cardiovascular risk factors (CVRF), which highlights the need to improve secondary prevention strategies aimed at improving their lifestyle and adherence to treatment. Through a randomized controlled clinical trial, this study aims to evaluate the effect of an intervention involving an online health application supported by a mobile telephone or tablet (mHealth) on lifestyle (diet, physical activity, and tobacco consumption) and treatment adherence among people with coronary heart disease after percutaneous coronary intervention. The sample will comprise 240 subjects (120 in each arm: intervention and usual care). They are assessed immediately and nine months after their hospital discharge about sociodemographic, clinical, CVRF, lifestyle, and treatment adherence characteristics. 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subjects | Angioplasty Applications programs Cardiac patients Cardiovascular disease Cardiovascular diseases Cardiovascular system Cell Phone Cell phones Cellular telephones Clinical outcomes Clinical trials Coronary artery disease Coronary Disease - prevention & control Coronary Disease - therapy Coronary heart disease Diet Disease prevention Exercise Health aspects Health risks Health services Heart Heart diseases Hospitals Humans Interactive control Internet Internet access Intervention Life Style Lifestyles Medical personnel Medical research Medicine, Experimental Mobile Applications Multivariate analysis Optimal control Patient compliance Physical activity Product development Risk analysis Risk factors Risk management Secondary Prevention - methods Smartphones Telemedicine - methods Text Messaging Tobacco Transluminal angioplasty Treatment Adherence and Compliance |
title | Lifestyle and Treatment Adherence Intervention after a Coronary Event Based on an Interactive Web Application (EVITE): Randomized Controlled Clinical Trial Protocol |
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