Effectiveness of a specific care plan in patients with Alzheimer’s disease: cluster randomised trial (PLASA study)
Identifieur interne : 001183 ( Istex/Corpus ); précédent : 001182; suivant : 001184Effectiveness of a specific care plan in patients with Alzheimer’s disease: cluster randomised trial (PLASA study)
Auteurs : Fati Nourhashemi ; Sandrine Andrieu ; Sophie Gillette-Guyonnet ; Bruno Giraudeau ; Christelle Cantet ; Nicola Coley ; Bruno VellasSource :
- BMJ [ 0959-8138 ] ; 2010.
Abstract
Objective To test the effectiveness of a comprehensive specific care plan in decreasing the rate of functional decline in patients with mild to moderate Alzheimer’s disease compared with usual care in memory clinics. Design Cluster randomised trial. Setting 50 memory clinics in France. Participants Patients with Alzheimer’s disease (mini-mental state examination score 12-26). 1131 patients were included: 574 from 26 clinics in the intervention group, and 557 from 24 clinics in the usual care (control) group. Memory clinics were the unit of randomisation. Intervention The intervention included a comprehensive standardised twice yearly consultation for patients and their caregivers, with standardised guidelines for the management of problems identified during the assessment. Main outcome measures The primary outcome measure was change on the Alzheimer’s Disease Cooperative Study-activities of daily living scale assessed at 12 and 24 months. Secondary outcome measures were the rate of admission to institutional care and mortality. Results At two years the assessment was completed by 58.4% (n=335) of patients in the intervention group and 61.6% (n=343) in the control group. The rate of functional decline at two years did not differ between the groups. The annual rate of change on the Alzheimer’s Disease Cooperative Study-activities of daily living was estimated at −5.73 (95% confidence interval −6.89 to −4.57) in the intervention group and −5.96 (−7.05 to −4.86) in the control group (P=0.78). Conclusion A comprehensive specific care plan in memory clinics had no additional positive effect on functional decline in patients with mild to moderate Alzheimer’s disease. Future research should aim to determine the effects of more direct involvement of general practitioners. Trial registration ClinicalTrials.gov NCT00480220.
Url:
DOI: 10.1136/bmj.c2466
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France</mods:affiliation></affiliation><affiliation><mods:affiliation>University of Toulouse III, France</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">BMJ</title><title level="j" type="abbrev">BMJ</title><idno type="ISSN">0959-8138</idno><idno type="eISSN">1468-5833</idno><imprint><publisher>British Medical Journal Publishing Group</publisher><date type="published" when="2010">2010</date><biblScope unit="volume">340</biblScope></imprint><idno type="ISSN">0959-8138</idno></series><idno type="istex">FF52288570DE05AA74E2A5E7C8196C19258AD889</idno><idno type="DOI">10.1136/bmj.c2466</idno><idno type="href">bmj-340-bmj-c2466.pdf</idno><idno type="ArticleID">nouf740902</idno><idno type="PMID">20522656</idno><idno type="local">bmj;340/jun03_1/c2466</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0959-8138</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">Objective To test the effectiveness of a comprehensive specific care plan in decreasing the rate of functional decline in patients with mild to moderate Alzheimer’s disease compared with usual care in memory clinics. Design Cluster randomised trial. Setting 50 memory clinics in France. Participants Patients with Alzheimer’s disease (mini-mental state examination score 12-26). 1131 patients were included: 574 from 26 clinics in the intervention group, and 557 from 24 clinics in the usual care (control) group. Memory clinics were the unit of randomisation. Intervention The intervention included a comprehensive standardised twice yearly consultation for patients and their caregivers, with standardised guidelines for the management of problems identified during the assessment. Main outcome measures The primary outcome measure was change on the Alzheimer’s Disease Cooperative Study-activities of daily living scale assessed at 12 and 24 months. Secondary outcome measures were the rate of admission to institutional care and mortality. Results At two years the assessment was completed by 58.4% (n=335) of patients in the intervention group and 61.6% (n=343) in the control group. The rate of functional decline at two years did not differ between the groups. The annual rate of change on the Alzheimer’s Disease Cooperative Study-activities of daily living was estimated at −5.73 (95% confidence interval −6.89 to −4.57) in the intervention group and −5.96 (−7.05 to −4.86) in the control group (P=0.78). Conclusion A comprehensive specific care plan in memory clinics had no additional positive effect on functional decline in patients with mild to moderate Alzheimer’s disease. Future research should aim to determine the effects of more direct involvement of general practitioners. Trial registration ClinicalTrials.gov NCT00480220.</div></front></TEI><istex><corpusName>bmj</corpusName><author><json:item><name>Fati Nourhashemi</name><affiliations><json:string>Gérontopôle, CMRR, Toulouse, France</json:string><json:string>Inserm U558, Toulouse, France</json:string><json:string>University of Toulouse III, France</json:string><json:string>E-mail: fatinour@orange.fr</json:string></affiliations></json:item><json:item><name>Sandrine Andrieu</name><affiliations><json:string>Gérontopôle, CMRR, Toulouse, France</json:string><json:string>Inserm U558, Toulouse, France</json:string><json:string>University of Toulouse III, France</json:string><json:string>Department of Epidemiology and Public Health, Toulouse University Hospital, France</json:string></affiliations></json:item><json:item><name>Sophie Gillette-Guyonnet</name><affiliations><json:string>Gérontopôle, CMRR, Toulouse, France</json:string><json:string>Inserm U558, Toulouse, France</json:string><json:string>University of Toulouse III, France</json:string></affiliations></json:item><json:item><name>Bruno Giraudeau</name><affiliations><json:string>Inserm CIC-202, Tours, France</json:string><json:string>François Rabelais University, Tours, France</json:string><json:string>CHRU de Tours, France</json:string></affiliations></json:item><json:item><name>Christelle Cantet</name><affiliations><json:string>Inserm U558, Toulouse, France</json:string><json:string>University of Toulouse III, France</json:string></affiliations></json:item><json:item><name>Nicola Coley</name><affiliations><json:string>Inserm U558, Toulouse, France</json:string><json:string>University of Toulouse III, France</json:string></affiliations></json:item><json:item><name>Bruno Vellas</name><affiliations><json:string>Gérontopôle, CMRR, Toulouse, France</json:string><json:string>Inserm U558, Toulouse, France</json:string><json:string>University of Toulouse III, France</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>Epidemiologic studies</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>General practice / family medicine</value></json:item></subject><articleId><json:string>nouf740902</json:string></articleId><language><json:string>eng</json:string></language><originalGenre><json:string>research-article</json:string></originalGenre><abstract>Objective To test the effectiveness of a comprehensive specific care plan in decreasing the rate of functional decline in patients with mild to moderate Alzheimer’s disease compared with usual care in memory clinics. Design Cluster randomised trial. Setting 50 memory clinics in France. Participants Patients with Alzheimer’s disease (mini-mental state examination score 12-26). 1131 patients were included: 574 from 26 clinics in the intervention group, and 557 from 24 clinics in the usual care (control) group. Memory clinics were the unit of randomisation. Intervention The intervention included a comprehensive standardised twice yearly consultation for patients and their caregivers, with standardised guidelines for the management of problems identified during the assessment. Main outcome measures The primary outcome measure was change on the Alzheimer’s Disease Cooperative Study-activities of daily living scale assessed at 12 and 24 months. Secondary outcome measures were the rate of admission to institutional care and mortality. Results At two years the assessment was completed by 58.4% (n=335) of patients in the intervention group and 61.6% (n=343) in the control group. The rate of functional decline at two years did not differ between the groups. The annual rate of change on the Alzheimer’s Disease Cooperative Study-activities of daily living was estimated at −5.73 (95% confidence interval −6.89 to −4.57) in the intervention group and −5.96 (−7.05 to −4.86) in the control group (P=0.78). Conclusion A comprehensive specific care plan in memory clinics had no additional positive effect on functional decline in patients with mild to moderate Alzheimer’s disease. Future research should aim to determine the effects of more direct involvement of general practitioners. 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type="biography">geriatrician</note><affiliation>geriatrician</affiliation><affiliation>Gérontopôle, CMRR, Toulouse, France</affiliation><affiliation>Inserm U558, Toulouse, France</affiliation><affiliation>University of Toulouse III, France</affiliation></author><author xml:id="author-2"><persName><forename type="first">Sandrine</forename><surname>Andrieu</surname></persName><note type="biography">epidemiologist</note><affiliation>epidemiologist</affiliation><affiliation>Gérontopôle, CMRR, Toulouse, France</affiliation><affiliation>Inserm U558, Toulouse, France</affiliation><affiliation>University of Toulouse III, France</affiliation><affiliation>Department of Epidemiology and Public Health, Toulouse University Hospital, France</affiliation></author><author xml:id="author-3"><persName><forename type="first">Sophie</forename><surname>Gillette-Guyonnet</surname></persName><note type="biography">research worker</note><affiliation>research worker</affiliation><affiliation>Gérontopôle, 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type="DOI">10.1136/bmj.c2466</idno><idno type="href">bmj-340-bmj-c2466.pdf</idno><idno type="ArticleID">nouf740902</idno><idno type="PMID">20522656</idno><idno type="local">bmj;340/jun03_1/c2466</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2010-06-03</date></creation><langUsage><language ident="en">en</language></langUsage><abstract><p>Objective To test the effectiveness of a comprehensive specific care plan in decreasing the rate of functional decline in patients with mild to moderate Alzheimer’s disease compared with usual care in memory clinics. Design Cluster randomised trial. Setting 50 memory clinics in France. Participants Patients with Alzheimer’s disease (mini-mental state examination score 12-26). 1131 patients were included: 574 from 26 clinics in the intervention group, and 557 from 24 clinics in the usual care (control) group. Memory clinics were the unit of randomisation. Intervention The intervention included a comprehensive standardised twice yearly consultation for patients and their caregivers, with standardised guidelines for the management of problems identified during the assessment. Main outcome measures The primary outcome measure was change on the Alzheimer’s Disease Cooperative Study-activities of daily living scale assessed at 12 and 24 months. Secondary outcome measures were the rate of admission to institutional care and mortality. Results At two years the assessment was completed by 58.4% (n=335) of patients in the intervention group and 61.6% (n=343) in the control group. The rate of functional decline at two years did not differ between the groups. The annual rate of change on the Alzheimer’s Disease Cooperative Study-activities of daily living was estimated at −5.73 (95% confidence interval −6.89 to −4.57) in the intervention group and −5.96 (−7.05 to −4.86) in the control group (P=0.78). Conclusion A comprehensive specific care plan in memory clinics had no additional positive effect on functional decline in patients with mild to moderate Alzheimer’s disease. Future research should aim to determine the effects of more direct involvement of general practitioners. 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standalone="no"</istex:xmlDeclaration><istex:docType PUBLIC="-//NLM//DTD Journal Archiving and Interchange DTD v2.3 20070202//EN" URI="archivearticle.dtd" name="istex:docType"></istex:docType><istex:document><article article-type="research-article"><front><journal-meta><journal-id journal-id-type="hwp">bmj</journal-id><journal-id journal-id-type="nlm-ta">BMJ</journal-id><journal-id journal-id-type="publisher-id">bmj</journal-id><journal-title>BMJ</journal-title><abbrev-journal-title abbrev-type="publisher">BMJ</abbrev-journal-title><issn pub-type="ppub">0959-8138</issn><issn pub-type="epub">1468-5833</issn><publisher><publisher-name>British Medical Journal Publishing Group</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">nouf740902</article-id><article-id pub-id-type="doi">10.1136/bmj.c2466</article-id><article-id pub-id-type="other">bmj;340/jun03_1/c2466</article-id><article-id pub-id-type="other">bmj;bmj.c2466</article-id><article-id pub-id-type="other">jun03_1</article-id><article-id pub-id-type="pmid">20522656</article-id><article-id pub-id-type="other">bmj.c2466</article-id><article-id pub-id-type="other">bmj.c2466</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>Epidemiologic studies</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>General practice / family medicine</subject></subj-group></article-categories><title-group><article-title>Effectiveness of a specific care plan in patients with Alzheimer’s disease: cluster randomised trial (PLASA study)</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Nourhashemi</surname><given-names>Fati</given-names></name><role>geriatrician</role><xref ref-type="aff" rid="aff1">1</xref><xref ref-type="aff" rid="aff2">2</xref><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Andrieu</surname><given-names>Sandrine</given-names></name><role>epidemiologist</role><xref ref-type="aff" rid="aff1">1</xref><xref ref-type="aff" rid="aff2">2</xref><xref ref-type="aff" rid="aff3">3</xref><xref ref-type="aff" rid="aff4">4</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Gillette-Guyonnet</surname><given-names>Sophie</given-names></name><role>research worker</role><xref ref-type="aff" rid="aff1">1</xref><xref ref-type="aff" rid="aff2">2</xref><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Giraudeau</surname><given-names>Bruno</given-names></name><role>statistician</role><xref ref-type="aff" rid="aff5">5</xref><xref ref-type="aff" rid="aff6">6</xref><xref ref-type="aff" rid="aff7">7</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Cantet</surname><given-names>Christelle</given-names></name><role>statistician</role><xref ref-type="aff" rid="aff2">2</xref><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Coley</surname><given-names>Nicola</given-names></name><role>research worker</role><xref ref-type="aff" rid="aff2">2</xref><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Vellas</surname><given-names>Bruno</given-names></name><role>geriatrician</role><xref ref-type="aff" rid="aff1">1</xref><xref ref-type="aff" rid="aff2">2</xref><xref ref-type="aff" rid="aff3">3</xref></contrib><on-behalf-of>on behalf of the PLASA Group</on-behalf-of><aff id="aff1"><label>1</label>Gérontopôle, CMRR, Toulouse, France</aff><aff id="aff2"><label>2</label>Inserm U558, Toulouse, France</aff><aff id="aff3"><label>3</label>University of Toulouse III, France</aff><aff id="aff4"><label>4</label>Department of Epidemiology and Public Health, Toulouse University Hospital, France</aff><aff id="aff5"><label>5</label>Inserm CIC-202, Tours, France</aff><aff id="aff6"><label>6</label>François Rabelais University, Tours, France</aff><aff id="aff7"><label>7</label>CHRU de Tours, France</aff></contrib-group><author-notes><corresp>Correspondence to: F Nourhashemi, Service de Médecine Interne et de Gérontologie Clinique, CHU Purpan-Casselardit, 170 chemin de Casselardit, 31059 Toulouse, France <email>fatinour@orange.fr</email></corresp></author-notes><pub-date pub-type="collection"><year>2010</year></pub-date><pub-date pub-type="ppub"><year>2010</year></pub-date><pub-date pub-type="epub-original"><year>2010</year></pub-date><pub-date pub-type="epub"><day>3</day><month>6</month><year>2010</year></pub-date><volume>340</volume><volume-id pub-id-type="other">340</volume-id><volume-id pub-id-type="other">340</volume-id><elocation-id>c2466</elocation-id><history><date date-type="accepted"><day>12</day><month>April</month><year>2010</year></date></history><permissions><copyright-statement>© Nourhashemi et al 2010</copyright-statement><copyright-year>2010</copyright-year><copyright-holder>Nourhashemi et al</copyright-holder><license license-type="open-access"><p>This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: <ext-link xlink:href="http://creativecommons.org/licenses/by-nc/2.0/" ext-link-type="uri">http://creativecommons.org/licenses/by-nc/2.0/</ext-link> and <ext-link xlink:href="http://creativecommons.org/licenses/by-nc/2.0/legalcode" ext-link-type="uri">http://creativecommons.org/licenses/by-nc/2.0/legalcode</ext-link>.</p></license></permissions><self-uri content-type="pdf" xlink:role="full-text" xlink:href="bmj-340-bmj-c2466.pdf"></self-uri><abstract><p><bold>Objective</bold> To test the effectiveness of a comprehensive specific care plan in decreasing the rate of functional decline in patients with mild to moderate Alzheimer’s disease compared with usual care in memory clinics.</p><p><bold>Design</bold> Cluster randomised trial.</p><p><bold>Setting</bold> 50 memory clinics in France.</p><p><bold>Participants</bold> Patients with Alzheimer’s disease (mini-mental state examination score 12-26). 1131 patients were included: 574 from 26 clinics in the intervention group, and 557 from 24 clinics in the usual care (control) group. Memory clinics were the unit of randomisation.</p><p><bold>Intervention</bold> The intervention included a comprehensive standardised twice yearly consultation for patients and their caregivers, with standardised guidelines for the management of problems identified during the assessment.</p><p><bold>Main outcome measures</bold> The primary outcome measure was change on the Alzheimer’s Disease Cooperative Study-activities of daily living scale assessed at 12 and 24 months. Secondary outcome measures were the rate of admission to institutional care and mortality.</p><p><bold>Results</bold> At two years the assessment was completed by 58.4% (n=335) of patients in the intervention group and 61.6% (n=343) in the control group. The rate of functional decline at two years did not differ between the groups. The annual rate of change on the Alzheimer’s Disease Cooperative Study-activities of daily living was estimated at −5.73 (95% confidence interval −6.89 to −4.57) in the intervention group and −5.96 (−7.05 to −4.86) in the control group (P=0.78).</p><p><bold>Conclusion</bold> A comprehensive specific care plan in memory clinics had no additional positive effect on functional decline in patients with mild to moderate Alzheimer’s disease. Future research should aim to determine the effects of more direct involvement of general practitioners.</p><p><bold>Trial registration</bold> ClinicalTrials.gov <ext-link ext-link-type="clintrialgov" xlink:href="NCT00480220">NCT00480220</ext-link>.</p></abstract></article-meta></front></article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo><title>Effectiveness of a specific care plan in patients with Alzheimer’s disease: cluster randomised trial (PLASA study)</title></titleInfo><titleInfo type="alternative" contentType="CDATA"><title>Effectiveness of a specific care plan in patients with Alzheimer’s disease: cluster randomised trial (PLASA study)</title></titleInfo><name type="personal" displayLabel="corresp"><namePart type="given">Fati</namePart><namePart type="family">Nourhashemi</namePart><affiliation>Gérontopôle, CMRR, Toulouse, France</affiliation><affiliation>Inserm U558, Toulouse, France</affiliation><affiliation>University of Toulouse III, France</affiliation><affiliation>E-mail: fatinour@orange.fr</affiliation><description>geriatrician</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Sandrine</namePart><namePart type="family">Andrieu</namePart><affiliation>Gérontopôle, CMRR, Toulouse, France</affiliation><affiliation>Inserm U558, Toulouse, France</affiliation><affiliation>University of Toulouse III, France</affiliation><affiliation>Department of Epidemiology and Public Health, Toulouse University Hospital, France</affiliation><description>epidemiologist</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Sophie</namePart><namePart type="family">Gillette-Guyonnet</namePart><affiliation>Gérontopôle, CMRR, Toulouse, France</affiliation><affiliation>Inserm U558, Toulouse, France</affiliation><affiliation>University of Toulouse III, France</affiliation><description>research worker</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Bruno</namePart><namePart type="family">Giraudeau</namePart><affiliation>Inserm CIC-202, Tours, France</affiliation><affiliation>François Rabelais University, Tours, France</affiliation><affiliation>CHRU de Tours, France</affiliation><description>statistician</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Christelle</namePart><namePart type="family">Cantet</namePart><affiliation>Inserm U558, Toulouse, France</affiliation><affiliation>University of Toulouse III, France</affiliation><description>statistician</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Nicola</namePart><namePart type="family">Coley</namePart><affiliation>Inserm U558, Toulouse, France</affiliation><affiliation>University of Toulouse III, France</affiliation><description>research worker</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Bruno</namePart><namePart type="family">Vellas</namePart><affiliation>Gérontopôle, CMRR, Toulouse, France</affiliation><affiliation>Inserm U558, Toulouse, France</affiliation><affiliation>University of Toulouse III, France</affiliation><description>geriatrician</description><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="research-article" displayLabel="research-article"></genre><subject><genre>hwp-journal-coll</genre><topic>Epidemiologic studies</topic></subject><subject><genre>hwp-journal-coll</genre><topic>General practice / family medicine</topic></subject><originInfo><publisher>British Medical Journal Publishing Group</publisher><dateIssued encoding="w3cdtf">2010</dateIssued><dateCreated encoding="w3cdtf">2010-06-03</dateCreated><copyrightDate encoding="w3cdtf">2010</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType></physicalDescription><abstract>Objective To test the effectiveness of a comprehensive specific care plan in decreasing the rate of functional decline in patients with mild to moderate Alzheimer’s disease compared with usual care in memory clinics. Design Cluster randomised trial. Setting 50 memory clinics in France. Participants Patients with Alzheimer’s disease (mini-mental state examination score 12-26). 1131 patients were included: 574 from 26 clinics in the intervention group, and 557 from 24 clinics in the usual care (control) group. Memory clinics were the unit of randomisation. Intervention The intervention included a comprehensive standardised twice yearly consultation for patients and their caregivers, with standardised guidelines for the management of problems identified during the assessment. Main outcome measures The primary outcome measure was change on the Alzheimer’s Disease Cooperative Study-activities of daily living scale assessed at 12 and 24 months. Secondary outcome measures were the rate of admission to institutional care and mortality. Results At two years the assessment was completed by 58.4% (n=335) of patients in the intervention group and 61.6% (n=343) in the control group. The rate of functional decline at two years did not differ between the groups. The annual rate of change on the Alzheimer’s Disease Cooperative Study-activities of daily living was estimated at −5.73 (95% confidence interval −6.89 to −4.57) in the intervention group and −5.96 (−7.05 to −4.86) in the control group (P=0.78). Conclusion A comprehensive specific care plan in memory clinics had no additional positive effect on functional decline in patients with mild to moderate Alzheimer’s disease. Future research should aim to determine the effects of more direct involvement of general practitioners. 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