The OPTIMIZE trial: Rationale and design of a randomized controlled trial of motivational enhancement therapy to improve adherence to statin medication.
Identifieur interne : 000D80 ( Main/Exploration ); précédent : 000D79; suivant : 000D81The OPTIMIZE trial: Rationale and design of a randomized controlled trial of motivational enhancement therapy to improve adherence to statin medication.
Auteurs : Joshua A. Rash [Canada] ; Kim L. Lavoie [Canada] ; Ronald J. Sigal [Canada] ; David J T. Campbell [Canada] ; Braden J. Manns [Canada] ; Marcello Tonelli [Canada] ; Tavis S. Campbell [Canada]Source :
- Contemporary clinical trials [ 1559-2030 ] ; 2016.
Descripteurs français
- KwdFr :
- MESH :
- méthodes : Entretien motivationnel.
- usage thérapeutique : Inhibiteurs de l'hydroxyméthylglutaryl-CoA réductase.
- Adhésion au traitement médicamenteux, Humains, Motivation, Méthode en double aveugle, Soins centrés sur le patient.
English descriptors
- KwdEn :
- MESH :
- chemical , therapeutic use : Hydroxymethylglutaryl-CoA Reductase Inhibitors.
- methods : Motivational Interviewing.
- Double-Blind Method, Humans, Medication Adherence, Motivation, Patient-Centered Care.
Abstract
BACKGROUND
Statins are a class of medications that are particularly effective for lowering cholesterol and reducing cardiovascular morbidity and mortality. Despite a range of benefits, non-adherence to statin medication is prevalent with 50% to 75% of patients failing to adhere to treatment within the first 2-years. A previous review on interventions to improve adherence to cholesterol lowering medication concluded that rigorous trials were needed with emphasis on the patient's perspective and shared decision making. Motivational interviewing (MInt) is a promising patient-centered approach for improving adherence in patients with chronic diseases. This manuscript describes the rational and design of a randomized controlled trial (RCT) testing the efficacy of MInt in improving adherence to statin medication.
METHODS
Patients filling their first statin prescription will be recruited to complete a 6-month observation run-in period (phase-1) after which medication possession ratio (MPR) will be assessed. Patients meeting criteria for non-adherence (MPR≤60%) will be invited to participate in the trial. 336 non-adherent new statin users will undergo a fasting lipid panel, complete baseline questionnaires, and be randomly allocated to receive four sessions of adherence education delivered using MInt (EdMInt) or to an education control (EC) delivered at 3-month intervals. Final assessments will occur 12-months after the first EdMInt or EC session. The primary outcome is change in MPR adherence to statin medication from baseline to 12-months. Secondary outcomes include within-patient change in self-reported medication adherence, stage of change and self-efficacy for medication adherence, motivation to adhere to statin medication, and lipid profile.
DOI: 10.1016/j.cct.2016.06.001
PubMed: 27282119
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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Rash</name><affiliation wicri:level="4"><nlm:affiliation>Department of Psychology, University of Calgary, 2500 University Drive N.W., Calgary, AB, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Psychology, University of Calgary, 2500 University Drive N.W., Calgary, AB</wicri:regionArea><orgName type="university">Université de Calgary</orgName><placeName><settlement type="city">Calgary</settlement><region type="state">Alberta</region></placeName></affiliation></author><author><name sortKey="Lavoie, Kim L" sort="Lavoie, Kim L" uniqKey="Lavoie K" first="Kim L" last="Lavoie">Kim L. Lavoie</name><affiliation wicri:level="1"><nlm:affiliation>Department of Psychology, University of Quebec at Montreal (UQAM), CP 8888, Succursale Centre-Ville, Montreal, QC, H3C 3P8, Canada; Montreal Behavioral Medicine Centre (MBMC), Research Centre, Hopital du Sacre-Coeur de Montreal, 5400 Gouin Blvd West, J-3145, Montreal, QC, H2J 1C5, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Psychology, University of Quebec at Montreal (UQAM), CP 8888, Succursale Centre-Ville, Montreal, QC, H3C 3P8, Canada; Montreal Behavioral Medicine Centre (MBMC), Research Centre, Hopital du Sacre-Coeur de Montreal, 5400 Gouin Blvd West, J-3145, Montreal, QC, H2J 1C5</wicri:regionArea><wicri:noRegion>H2J 1C5</wicri:noRegion></affiliation></author><author><name sortKey="Sigal, Ronald J" sort="Sigal, Ronald J" uniqKey="Sigal R" first="Ronald J" last="Sigal">Ronald J. Sigal</name><affiliation wicri:level="4"><nlm:affiliation>Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Cardiac Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Cardiac Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB</wicri:regionArea><orgName type="university">Université de Calgary</orgName><placeName><settlement type="city">Calgary</settlement><region type="state">Alberta</region></placeName></affiliation></author><author><name sortKey="Campbell, David J T" sort="Campbell, David J T" uniqKey="Campbell D" first="David J T" last="Campbell">David J T. Campbell</name><affiliation wicri:level="4"><nlm:affiliation>Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB</wicri:regionArea><orgName type="university">Université de Calgary</orgName><placeName><settlement type="city">Calgary</settlement><region type="state">Alberta</region></placeName></affiliation></author><author><name sortKey="Manns, Braden J" sort="Manns, Braden J" uniqKey="Manns B" first="Braden J" last="Manns">Braden J. Manns</name><affiliation wicri:level="4"><nlm:affiliation>Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Cardiac Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Cardiac Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB</wicri:regionArea><orgName type="university">Université de Calgary</orgName><placeName><settlement type="city">Calgary</settlement><region type="state">Alberta</region></placeName></affiliation></author><author><name sortKey="Tonelli, Marcello" sort="Tonelli, Marcello" uniqKey="Tonelli M" first="Marcello" last="Tonelli">Marcello Tonelli</name><affiliation wicri:level="4"><nlm:affiliation>Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB</wicri:regionArea><orgName type="university">Université de Calgary</orgName><placeName><settlement type="city">Calgary</settlement><region type="state">Alberta</region></placeName></affiliation></author><author><name sortKey="Campbell, Tavis S" sort="Campbell, Tavis S" uniqKey="Campbell T" first="Tavis S" last="Campbell">Tavis S. Campbell</name><affiliation wicri:level="4"><nlm:affiliation>Department of Psychology, University of Calgary, 2500 University Drive N.W., Calgary, AB, Canada. Electronic address: t.s.campbell@ucalgary.ca.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Psychology, University of Calgary, 2500 University Drive N.W., Calgary, AB</wicri:regionArea><orgName type="university">Université de Calgary</orgName><placeName><settlement type="city">Calgary</settlement><region type="state">Alberta</region></placeName></affiliation></author></analytic><series><title level="j">Contemporary clinical trials</title><idno type="eISSN">1559-2030</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Double-Blind Method (MeSH)</term><term>Humans (MeSH)</term><term>Hydroxymethylglutaryl-CoA Reductase Inhibitors (therapeutic use)</term><term>Medication Adherence (MeSH)</term><term>Motivation (MeSH)</term><term>Motivational Interviewing (methods)</term><term>Patient-Centered Care (MeSH)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adhésion au traitement médicamenteux (MeSH)</term><term>Entretien motivationnel (méthodes)</term><term>Humains (MeSH)</term><term>Inhibiteurs de l'hydroxyméthylglutaryl-CoA réductase (usage thérapeutique)</term><term>Motivation (MeSH)</term><term>Méthode en double aveugle (MeSH)</term><term>Soins centrés sur le patient (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Hydroxymethylglutaryl-CoA Reductase Inhibitors</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Motivational Interviewing</term></keywords><keywords scheme="MESH" qualifier="méthodes" xml:lang="fr"><term>Entretien motivationnel</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Inhibiteurs de l'hydroxyméthylglutaryl-CoA réductase</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Double-Blind Method</term><term>Humans</term><term>Medication Adherence</term><term>Motivation</term><term>Patient-Centered Care</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adhésion au traitement médicamenteux</term><term>Humains</term><term>Motivation</term><term>Méthode en double aveugle</term><term>Soins centrés sur le patient</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>Statins are a class of medications that are particularly effective for lowering cholesterol and reducing cardiovascular morbidity and mortality. Despite a range of benefits, non-adherence to statin medication is prevalent with 50% to 75% of patients failing to adhere to treatment within the first 2-years. A previous review on interventions to improve adherence to cholesterol lowering medication concluded that rigorous trials were needed with emphasis on the patient's perspective and shared decision making. Motivational interviewing (MInt) is a promising patient-centered approach for improving adherence in patients with chronic diseases. This manuscript describes the rational and design of a randomized controlled trial (RCT) testing the efficacy of MInt in improving adherence to statin medication.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>Patients filling their first statin prescription will be recruited to complete a 6-month observation run-in period (phase-1) after which medication possession ratio (MPR) will be assessed. Patients meeting criteria for non-adherence (MPR≤60%) will be invited to participate in the trial. 336 non-adherent new statin users will undergo a fasting lipid panel, complete baseline questionnaires, and be randomly allocated to receive four sessions of adherence education delivered using MInt (EdMInt) or to an education control (EC) delivered at 3-month intervals. Final assessments will occur 12-months after the first EdMInt or EC session. The primary outcome is change in MPR adherence to statin medication from baseline to 12-months. Secondary outcomes include within-patient change in self-reported medication adherence, stage of change and self-efficacy for medication adherence, motivation to adhere to statin medication, and lipid profile.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">27282119</PMID><DateCompleted><Year>2017</Year><Month>11</Month><Day>30</Day></DateCompleted><DateRevised><Year>2018</Year><Month>02</Month><Day>09</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1559-2030</ISSN><JournalIssue CitedMedium="Internet"><Volume>49</Volume><PubDate><Year>2016</Year><Month>07</Month></PubDate></JournalIssue><Title>Contemporary clinical trials</Title><ISOAbbreviation>Contemp Clin Trials</ISOAbbreviation></Journal><ArticleTitle>The OPTIMIZE trial: Rationale and design of a randomized controlled trial of motivational enhancement therapy to improve adherence to statin medication.</ArticleTitle><Pagination><MedlinePgn>47-56</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.cct.2016.06.001</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S1551-7144(16)30080-5</ELocationID><Abstract><AbstractText Label="BACKGROUND">Statins are a class of medications that are particularly effective for lowering cholesterol and reducing cardiovascular morbidity and mortality. Despite a range of benefits, non-adherence to statin medication is prevalent with 50% to 75% of patients failing to adhere to treatment within the first 2-years. A previous review on interventions to improve adherence to cholesterol lowering medication concluded that rigorous trials were needed with emphasis on the patient's perspective and shared decision making. Motivational interviewing (MInt) is a promising patient-centered approach for improving adherence in patients with chronic diseases. This manuscript describes the rational and design of a randomized controlled trial (RCT) testing the efficacy of MInt in improving adherence to statin medication.</AbstractText><AbstractText Label="METHODS">Patients filling their first statin prescription will be recruited to complete a 6-month observation run-in period (phase-1) after which medication possession ratio (MPR) will be assessed. Patients meeting criteria for non-adherence (MPR≤60%) will be invited to participate in the trial. 336 non-adherent new statin users will undergo a fasting lipid panel, complete baseline questionnaires, and be randomly allocated to receive four sessions of adherence education delivered using MInt (EdMInt) or to an education control (EC) delivered at 3-month intervals. Final assessments will occur 12-months after the first EdMInt or EC session. The primary outcome is change in MPR adherence to statin medication from baseline to 12-months. Secondary outcomes include within-patient change in self-reported medication adherence, stage of change and self-efficacy for medication adherence, motivation to adhere to statin medication, and lipid profile.</AbstractText><CopyrightInformation>Copyright © 2016 Elsevier Inc. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Rash</LastName><ForeName>Joshua A</ForeName><Initials>JA</Initials><AffiliationInfo><Affiliation>Department of Psychology, University of Calgary, 2500 University Drive N.W., Calgary, AB, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lavoie</LastName><ForeName>Kim L</ForeName><Initials>KL</Initials><AffiliationInfo><Affiliation>Department of Psychology, University of Quebec at Montreal (UQAM), CP 8888, Succursale Centre-Ville, Montreal, QC, H3C 3P8, Canada; Montreal Behavioral Medicine Centre (MBMC), Research Centre, Hopital du Sacre-Coeur de Montreal, 5400 Gouin Blvd West, J-3145, Montreal, QC, H2J 1C5, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sigal</LastName><ForeName>Ronald J</ForeName><Initials>RJ</Initials><AffiliationInfo><Affiliation>Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Cardiac Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Campbell</LastName><ForeName>David J T</ForeName><Initials>DJ</Initials><AffiliationInfo><Affiliation>Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Manns</LastName><ForeName>Braden J</ForeName><Initials>BJ</Initials><AffiliationInfo><Affiliation>Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Cardiac Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tonelli</LastName><ForeName>Marcello</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Campbell</LastName><ForeName>Tavis S</ForeName><Initials>TS</Initials><AffiliationInfo><Affiliation>Department of Psychology, University of Calgary, 2500 University Drive N.W., Calgary, AB, Canada. Electronic address: t.s.campbell@ucalgary.ca.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><Agency>CIHR</Agency><Country>Canada</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2016</Year><Month>06</Month><Day>06</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Contemp Clin Trials</MedlineTA><NlmUniqueID>101242342</NlmUniqueID><ISSNLinking>1551-7144</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D019161">Hydroxymethylglutaryl-CoA Reductase Inhibitors</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D019161" MajorTopicYN="N">Hydroxymethylglutaryl-CoA Reductase Inhibitors</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D055118" MajorTopicYN="Y">Medication Adherence</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009042" MajorTopicYN="N">Motivation</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D062405" MajorTopicYN="N">Motivational Interviewing</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D018802" MajorTopicYN="N">Patient-Centered Care</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">Adherence</Keyword><Keyword MajorTopicYN="Y">Compliance</Keyword><Keyword MajorTopicYN="Y">Medication</Keyword><Keyword MajorTopicYN="Y">Motivational interviewing</Keyword><Keyword MajorTopicYN="Y">Randomized controlled trial</Keyword><Keyword MajorTopicYN="Y">Statin</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year><Month>04</Month><Day>21</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2016</Year><Month>05</Month><Day>30</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2016</Year><Month>06</Month><Day>04</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>6</Month><Day>11</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2016</Year><Month>6</Month><Day>11</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>12</Month><Day>1</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">27282119</ArticleId><ArticleId IdType="pii">S1551-7144(16)30080-5</ArticleId><ArticleId IdType="doi">10.1016/j.cct.2016.06.001</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Canada</li></country><region><li>Alberta</li></region><settlement><li>Calgary</li></settlement><orgName><li>Université de Calgary</li></orgName></list><tree><country name="Canada"><region name="Alberta"><name sortKey="Rash, Joshua A" sort="Rash, Joshua A" uniqKey="Rash J" first="Joshua A" last="Rash">Joshua A. Rash</name></region><name sortKey="Campbell, David J T" sort="Campbell, David J T" uniqKey="Campbell D" first="David J T" last="Campbell">David J T. Campbell</name><name sortKey="Campbell, Tavis S" sort="Campbell, Tavis S" uniqKey="Campbell T" first="Tavis S" last="Campbell">Tavis S. Campbell</name><name sortKey="Lavoie, Kim L" sort="Lavoie, Kim L" uniqKey="Lavoie K" first="Kim L" last="Lavoie">Kim L. Lavoie</name><name sortKey="Manns, Braden J" sort="Manns, Braden J" uniqKey="Manns B" first="Braden J" last="Manns">Braden J. Manns</name><name sortKey="Sigal, Ronald J" sort="Sigal, Ronald J" uniqKey="Sigal R" first="Ronald J" last="Sigal">Ronald J. Sigal</name><name sortKey="Tonelli, Marcello" sort="Tonelli, Marcello" uniqKey="Tonelli M" first="Marcello" last="Tonelli">Marcello Tonelli</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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