Effectiveness of a multifactorial intervention, consisting of self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise, in patients with uncontrolled hypertension taking 2 or more antihypertensive drugs: The MEDICHY study
High blood pressure is the leading modifiable risk factor for cardiovascular disease, and is associated with high morbidity and mortality and with significant health care costs for individuals and society. However, fewer than half of the patients with hypertension receiving pharmacological treatment...
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creator | Unda Villafuerte, Fabián Llobera Cànaves, Joan Lorente Montalvo, Patricia Moreno Sancho, María Lucía Oliver Oliver, Bartolomé Bassante Flores, Patricia Estela Mantolan, Andreu Pou Bordoy, Joan Rodríguez Ruiz, Tomás Requena Hernández, Ana Leiva, Alfonso Torrent Quetglas, Matíes Coll Benejam, José María D’Agosto Forteza, Pilar Rigo Carratalà, Fernando |
description | High blood pressure is the leading modifiable risk factor for cardiovascular disease, and is associated with high morbidity and mortality and with significant health care costs for individuals and society. However, fewer than half of the patients with hypertension receiving pharmacological treatment have adequate blood pressure control. The main reasons for this are therapeutic inertia, lack of adherence to treatment, and unhealthy lifestyle (i.e., excess dietary fat and salt, sedentary lifestyle, and overweight). Cardiovascular risk and mortality are greater in hypertensive patients who are receiving treatment but have suboptimal control of blood pressure.
This is a multicentre, parallel, 2-arm, single-blind (outcome assessor), controled, cluster-randomized clinical trial. General practitioners and nurses will be randomly allocated to the intervention group (self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise) or the control group (regular clinical practice). A total of 424 patients in primary care centers who use 2 or more antihypertensive drugs and blood pressure of at least 130/80 during 24-hambulatory blood pressure monitoring will be recruited. The primary outcome is systolic blood pressure at 12 months. The secondary outcomes are blood pressure control ( |
doi_str_mv | 10.1097/MD.0000000000019769 |
format | Article |
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This is a multicentre, parallel, 2-arm, single-blind (outcome assessor), controled, cluster-randomized clinical trial. General practitioners and nurses will be randomly allocated to the intervention group (self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise) or the control group (regular clinical practice). A total of 424 patients in primary care centers who use 2 or more antihypertensive drugs and blood pressure of at least 130/80 during 24-hambulatory blood pressure monitoring will be recruited. The primary outcome is systolic blood pressure at 12 months. The secondary outcomes are blood pressure control (<140/90 mm Hg); quality of life (EuroQol 5D); direct health care costs; adherence to use of antihypertensive medication; and cardiovascular risk (REGICOR and SCORE scales).
This trial will be conducted in the primary care setting and will evaluate the impact of a multifactorial intervention consisting of self-management of blood pressure, antihypertensive medications, and lifestyle modifications (hypocaloric and low sodium diet and physical exercise).</description><identifier>ISSN: 0025-7974</identifier><identifier>ISSN: 1536-5964</identifier><identifier>EISSN: 1536-5964</identifier><identifier>DOI: 10.1097/MD.0000000000019769</identifier><identifier>PMID: 32332617</identifier><language>eng</language><publisher>United States: the Author(s). Published by Wolters Kluwer Health, Inc</publisher><subject>Adult ; Aged ; Antihypertensive Agents - standards ; Antihypertensive Agents - therapeutic use ; Blood Pressure - drug effects ; Blood Pressure Determination - methods ; Blood Pressure Determination - standards ; Caloric Restriction - methods ; Cluster Analysis ; Diet, Sodium-Restricted - methods ; Exercise - physiology ; Female ; Humans ; Hypertension - drug therapy ; Hypertension - psychology ; Life Style ; Male ; Middle Aged ; Risk Factors ; Self-Management - methods ; Self-Management - psychology ; Study Protocol Clinical Trial ; Treatment Adherence and Compliance - psychology ; Treatment Outcome</subject><ispartof>Medicine (Baltimore), 2020-04, Vol.99 (17), p.e19769-e19769</ispartof><rights>the Author(s). Published by Wolters Kluwer Health, Inc.</rights><rights>Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc. 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3558-138995e201a6ea4e8f90dbe307ea3dc1a6853e63c242c790be276655a4415d113</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7220514/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7220514/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,724,777,781,861,882,27905,27906,53772,53774</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32332617$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Unda Villafuerte, Fabián</creatorcontrib><creatorcontrib>Llobera Cànaves, Joan</creatorcontrib><creatorcontrib>Lorente Montalvo, Patricia</creatorcontrib><creatorcontrib>Moreno Sancho, María Lucía</creatorcontrib><creatorcontrib>Oliver Oliver, Bartolomé</creatorcontrib><creatorcontrib>Bassante Flores, Patricia</creatorcontrib><creatorcontrib>Estela Mantolan, Andreu</creatorcontrib><creatorcontrib>Pou Bordoy, Joan</creatorcontrib><creatorcontrib>Rodríguez Ruiz, Tomás</creatorcontrib><creatorcontrib>Requena Hernández, Ana</creatorcontrib><creatorcontrib>Leiva, Alfonso</creatorcontrib><creatorcontrib>Torrent Quetglas, Matíes</creatorcontrib><creatorcontrib>Coll Benejam, José María</creatorcontrib><creatorcontrib>D’Agosto Forteza, Pilar</creatorcontrib><creatorcontrib>Rigo Carratalà, Fernando</creatorcontrib><creatorcontrib>and the Medichy Group</creatorcontrib><title>Effectiveness of a multifactorial intervention, consisting of self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise, in patients with uncontrolled hypertension taking 2 or more antihypertensive drugs: The MEDICHY study</title><title>Medicine (Baltimore)</title><addtitle>Medicine (Baltimore)</addtitle><description>High blood pressure is the leading modifiable risk factor for cardiovascular disease, and is associated with high morbidity and mortality and with significant health care costs for individuals and society. However, fewer than half of the patients with hypertension receiving pharmacological treatment have adequate blood pressure control. The main reasons for this are therapeutic inertia, lack of adherence to treatment, and unhealthy lifestyle (i.e., excess dietary fat and salt, sedentary lifestyle, and overweight). Cardiovascular risk and mortality are greater in hypertensive patients who are receiving treatment but have suboptimal control of blood pressure.
This is a multicentre, parallel, 2-arm, single-blind (outcome assessor), controled, cluster-randomized clinical trial. General practitioners and nurses will be randomly allocated to the intervention group (self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise) or the control group (regular clinical practice). A total of 424 patients in primary care centers who use 2 or more antihypertensive drugs and blood pressure of at least 130/80 during 24-hambulatory blood pressure monitoring will be recruited. The primary outcome is systolic blood pressure at 12 months. The secondary outcomes are blood pressure control (<140/90 mm Hg); quality of life (EuroQol 5D); direct health care costs; adherence to use of antihypertensive medication; and cardiovascular risk (REGICOR and SCORE scales).
This trial will be conducted in the primary care setting and will evaluate the impact of a multifactorial intervention consisting of self-management of blood pressure, antihypertensive medications, and lifestyle modifications (hypocaloric and low sodium diet and physical exercise).</description><subject>Adult</subject><subject>Aged</subject><subject>Antihypertensive Agents - standards</subject><subject>Antihypertensive Agents - therapeutic use</subject><subject>Blood Pressure - drug effects</subject><subject>Blood Pressure Determination - methods</subject><subject>Blood Pressure Determination - standards</subject><subject>Caloric Restriction - methods</subject><subject>Cluster Analysis</subject><subject>Diet, Sodium-Restricted - methods</subject><subject>Exercise - physiology</subject><subject>Female</subject><subject>Humans</subject><subject>Hypertension - drug therapy</subject><subject>Hypertension - psychology</subject><subject>Life Style</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Risk Factors</subject><subject>Self-Management - methods</subject><subject>Self-Management - psychology</subject><subject>Study Protocol Clinical Trial</subject><subject>Treatment Adherence and Compliance - psychology</subject><subject>Treatment Outcome</subject><issn>0025-7974</issn><issn>1536-5964</issn><issn>1536-5964</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNplkktvEzEUhQcEoqHwC5CQlywyrV8zHrNAQkmglVqxKQtWI8dzJ2PqGQfbk5B_j5OUlIc3lu79zjnX1s2yNwRfECzF5e38Aj8eIkUpn2YTUrAyL2TJn2UTjGmRCyn4WfYyhO8JYoLyF9kZo4zRkojJk8tF24KOZgMDhIBcixTqRxtNq3R03iiLzBDBp340bpgi7YZgQjTDag8HsG3eq0GtoE_EQZ_AbrcGHyGRG0A9NEaro_rIgwqjPwmW1rkGrX3KT9UpSmKnlU3hOpk1yLotCq4xY48aA3F6KK67XUiuFsFP8NqEpDMDWqeY5BrQ1sQOjUMaNnpnLTTocSQ3oKju9w-gyHnUOw__D934cRXeo7sO0O1ifj27-oZCHJvdq-x5q2yA1w_3efb10-JudpXffPl8Pft4k2tWFFVOWCVlARQTVYLiULUSN0tgWIBijU7VqmBQMk051ULiJVBRlkWhOCdFQwg7zz4cfdfjMn2gTq_yytZrb3rld7VTpv67M5iuXrlNLSjFBeHJ4N2DgXc_Rgix7k3QYK0awI2hpkzySkhORULZEdXeheChPcUQXO9Xrb6d1_-uWlK9_XPCk-b3biWAH4Gts2mDwr0dt-DrDpSN3cGvEJLmFFOMOeU4TxVasV-4t-g9</recordid><startdate>20200401</startdate><enddate>20200401</enddate><creator>Unda Villafuerte, Fabián</creator><creator>Llobera Cànaves, Joan</creator><creator>Lorente Montalvo, Patricia</creator><creator>Moreno Sancho, María Lucía</creator><creator>Oliver Oliver, Bartolomé</creator><creator>Bassante Flores, Patricia</creator><creator>Estela Mantolan, Andreu</creator><creator>Pou Bordoy, Joan</creator><creator>Rodríguez Ruiz, Tomás</creator><creator>Requena Hernández, Ana</creator><creator>Leiva, Alfonso</creator><creator>Torrent Quetglas, Matíes</creator><creator>Coll Benejam, José María</creator><creator>D’Agosto Forteza, Pilar</creator><creator>Rigo Carratalà, Fernando</creator><general>the Author(s). Published by Wolters Kluwer Health, Inc</general><general>Wolters Kluwer Health</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>7X8</scope><scope>5PM</scope></search><sort><creationdate>20200401</creationdate><title>Effectiveness of a multifactorial intervention, consisting of self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise, in patients with uncontrolled hypertension taking 2 or more antihypertensive drugs: The MEDICHY study</title><author>Unda Villafuerte, Fabián ; Llobera Cànaves, Joan ; Lorente Montalvo, Patricia ; Moreno Sancho, María Lucía ; Oliver Oliver, Bartolomé ; Bassante Flores, Patricia ; Estela Mantolan, Andreu ; Pou Bordoy, Joan ; Rodríguez Ruiz, Tomás ; Requena Hernández, Ana ; Leiva, Alfonso ; Torrent Quetglas, Matíes ; Coll Benejam, José María ; D’Agosto Forteza, Pilar ; Rigo Carratalà, Fernando</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3558-138995e201a6ea4e8f90dbe307ea3dc1a6853e63c242c790be276655a4415d113</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Antihypertensive Agents - standards</topic><topic>Antihypertensive Agents - therapeutic use</topic><topic>Blood Pressure - drug effects</topic><topic>Blood Pressure Determination - methods</topic><topic>Blood Pressure Determination - standards</topic><topic>Caloric Restriction - methods</topic><topic>Cluster Analysis</topic><topic>Diet, Sodium-Restricted - methods</topic><topic>Exercise - physiology</topic><topic>Female</topic><topic>Humans</topic><topic>Hypertension - drug therapy</topic><topic>Hypertension - psychology</topic><topic>Life Style</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Risk Factors</topic><topic>Self-Management - methods</topic><topic>Self-Management - psychology</topic><topic>Study Protocol Clinical Trial</topic><topic>Treatment Adherence and Compliance - psychology</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Unda Villafuerte, Fabián</creatorcontrib><creatorcontrib>Llobera Cànaves, Joan</creatorcontrib><creatorcontrib>Lorente Montalvo, Patricia</creatorcontrib><creatorcontrib>Moreno Sancho, María Lucía</creatorcontrib><creatorcontrib>Oliver Oliver, Bartolomé</creatorcontrib><creatorcontrib>Bassante Flores, Patricia</creatorcontrib><creatorcontrib>Estela Mantolan, Andreu</creatorcontrib><creatorcontrib>Pou Bordoy, Joan</creatorcontrib><creatorcontrib>Rodríguez Ruiz, Tomás</creatorcontrib><creatorcontrib>Requena Hernández, Ana</creatorcontrib><creatorcontrib>Leiva, Alfonso</creatorcontrib><creatorcontrib>Torrent Quetglas, Matíes</creatorcontrib><creatorcontrib>Coll Benejam, José María</creatorcontrib><creatorcontrib>D’Agosto Forteza, Pilar</creatorcontrib><creatorcontrib>Rigo Carratalà, Fernando</creatorcontrib><creatorcontrib>and the Medichy Group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Medicine (Baltimore)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Unda Villafuerte, Fabián</au><au>Llobera Cànaves, Joan</au><au>Lorente Montalvo, Patricia</au><au>Moreno Sancho, María Lucía</au><au>Oliver Oliver, Bartolomé</au><au>Bassante Flores, Patricia</au><au>Estela Mantolan, Andreu</au><au>Pou Bordoy, Joan</au><au>Rodríguez Ruiz, Tomás</au><au>Requena Hernández, Ana</au><au>Leiva, Alfonso</au><au>Torrent Quetglas, Matíes</au><au>Coll Benejam, José María</au><au>D’Agosto Forteza, Pilar</au><au>Rigo Carratalà, Fernando</au><aucorp>and the Medichy Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effectiveness of a multifactorial intervention, consisting of self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise, in patients with uncontrolled hypertension taking 2 or more antihypertensive drugs: The MEDICHY study</atitle><jtitle>Medicine (Baltimore)</jtitle><addtitle>Medicine (Baltimore)</addtitle><date>2020-04-01</date><risdate>2020</risdate><volume>99</volume><issue>17</issue><spage>e19769</spage><epage>e19769</epage><pages>e19769-e19769</pages><issn>0025-7974</issn><issn>1536-5964</issn><eissn>1536-5964</eissn><abstract>High blood pressure is the leading modifiable risk factor for cardiovascular disease, and is associated with high morbidity and mortality and with significant health care costs for individuals and society. However, fewer than half of the patients with hypertension receiving pharmacological treatment have adequate blood pressure control. The main reasons for this are therapeutic inertia, lack of adherence to treatment, and unhealthy lifestyle (i.e., excess dietary fat and salt, sedentary lifestyle, and overweight). Cardiovascular risk and mortality are greater in hypertensive patients who are receiving treatment but have suboptimal control of blood pressure.
This is a multicentre, parallel, 2-arm, single-blind (outcome assessor), controled, cluster-randomized clinical trial. General practitioners and nurses will be randomly allocated to the intervention group (self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise) or the control group (regular clinical practice). A total of 424 patients in primary care centers who use 2 or more antihypertensive drugs and blood pressure of at least 130/80 during 24-hambulatory blood pressure monitoring will be recruited. The primary outcome is systolic blood pressure at 12 months. The secondary outcomes are blood pressure control (<140/90 mm Hg); quality of life (EuroQol 5D); direct health care costs; adherence to use of antihypertensive medication; and cardiovascular risk (REGICOR and SCORE scales).
This trial will be conducted in the primary care setting and will evaluate the impact of a multifactorial intervention consisting of self-management of blood pressure, antihypertensive medications, and lifestyle modifications (hypocaloric and low sodium diet and physical exercise).</abstract><cop>United States</cop><pub>the Author(s). Published by Wolters Kluwer Health, Inc</pub><pmid>32332617</pmid><doi>10.1097/MD.0000000000019769</doi><oa>free_for_read</oa></addata></record> |
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subjects | Adult Aged Antihypertensive Agents - standards Antihypertensive Agents - therapeutic use Blood Pressure - drug effects Blood Pressure Determination - methods Blood Pressure Determination - standards Caloric Restriction - methods Cluster Analysis Diet, Sodium-Restricted - methods Exercise - physiology Female Humans Hypertension - drug therapy Hypertension - psychology Life Style Male Middle Aged Risk Factors Self-Management - methods Self-Management - psychology Study Protocol Clinical Trial Treatment Adherence and Compliance - psychology Treatment Outcome |
title | Effectiveness of a multifactorial intervention, consisting of self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise, in patients with uncontrolled hypertension taking 2 or more antihypertensive drugs: The MEDICHY study |
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