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T49. THE NEURAPRO STUDY: ADHERENCE TO STUDY MEDICATION

Abstract Background Adherence to a medication is generally defined as the extent to which patients take medications as prescribed by their health care providers. Poor adherence to study medication is not uncommon posing a major challenge to treatment trails. However, poor adherence may not be random...

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Published in:Schizophrenia bulletin 2018-04, Vol.44 (suppl_1), p.S132-S133
Main Authors: Schlögelhofer, Monika, McGorry, Patrick D, Nelson, Barnaby, Markulev, Connie, Yuen, Hok Pan, Schäfer, Miriam, Mossaheb, Nilufar, Smesny, Stefan, Hickie, Ian B, Berger, Gregor, Chen, Eric Y H, de Haan, Lieuwe, Nieman, Dorien H, Nordentoft, Merete, Riecher-Rössler, Anita, Verma, Swapna, Thompson, Andrew, Yung, Alison Ruth, Paul Amminger, G
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container_end_page S133
container_issue suppl_1
container_start_page S132
container_title Schizophrenia bulletin
container_volume 44
creator Schlögelhofer, Monika
McGorry, Patrick D
Nelson, Barnaby
Markulev, Connie
Yuen, Hok Pan
Schäfer, Miriam
Mossaheb, Nilufar
Smesny, Stefan
Hickie, Ian B
Berger, Gregor
Chen, Eric Y H
de Haan, Lieuwe
Nieman, Dorien H
Nordentoft, Merete
Riecher-Rössler, Anita
Verma, Swapna
Thompson, Andrew
Yung, Alison Ruth
Paul Amminger, G
description Abstract Background Adherence to a medication is generally defined as the extent to which patients take medications as prescribed by their health care providers. Poor adherence to study medication is not uncommon posing a major challenge to treatment trails. However, poor adherence may not be randomly distributed but rather be associated with demographic or illness factors. The aim of the present study was to identify factors associated with adherence to study medication in young people at ultrahigh risk of psychosis who participated in the NEURAPRO study. Methods Secondary analysis of data collected in a multi-centre, double-blind, placebo-controlled, randomized clinical trial to prevent or delay the onset of psychosis in participants at ultrahigh risk of psychosis testing omega-3 polyunsaturated fatty acids (omega-3 PUFAs) vs. placebo, in combination with cognitive behavioural case management (NEURAPRO) were included in this analysis. Measures included the Brief Psychiatric Rating Scale (BPRS), the Scale for the Assessment of Negative Symptoms (SANS), the Montgomery Asberg Depression Rating Scale (MADRS), the Young Mania Rating Scale (YMRS), the Social and Occupational Functioning Assessment Scale (SOFAS), and the Global Functioning: Social and Role scales. Adherence to the study medication was assessed monthly for each participant based on capsule count. The mean adherence rating over the 6-month intervention period was then computed and categorized as either adherent (≤25% of capsules returned) or non-adherent (>25% of capsules returned). Transition to psychosis was defined on the basis of operationalized criteria and assessed with the Comprehensive Assessment of the At-Risk Mental State. Levels of ω-3 PUFAs in fish oil, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (amongst other fatty acids) were measured as percentage of total fatty acids in erythrocytes at baseline and at month 6 (end-of-intervention). Results Of 304 randomised participants, 57.9% (N = 176) were non-adherent (>25% of capsules returned) and 128 (42.1%) were adherent (≤25% capsules returned) to the study medication. No sex differences were observed for adherence rates. At baseline the omega-3 index (EPA+DHA) was significantly lower in the non-adherent group (P = 0.018). The non-adherent group had significant lower scores on the SOFAS (P = 0.001) and the Global Functioning: Social and Role Scale at baseline assessment (P < 0.001 and P = 0.020, respectively) compared to th
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THE NEURAPRO STUDY: ADHERENCE TO STUDY MEDICATION</title><source>Open Access: PubMed Central</source><source>Oxford Journals Online</source><creator>Schlögelhofer, Monika ; McGorry, Patrick D ; Nelson, Barnaby ; Markulev, Connie ; Yuen, Hok Pan ; Schäfer, Miriam ; Mossaheb, Nilufar ; Smesny, Stefan ; Hickie, Ian B ; Berger, Gregor ; Chen, Eric Y H ; de Haan, Lieuwe ; Nieman, Dorien H ; Nordentoft, Merete ; Riecher-Rössler, Anita ; Verma, Swapna ; Thompson, Andrew ; Yung, Alison Ruth ; Paul Amminger, G</creator><creatorcontrib>Schlögelhofer, Monika ; McGorry, Patrick D ; Nelson, Barnaby ; Markulev, Connie ; Yuen, Hok Pan ; Schäfer, Miriam ; Mossaheb, Nilufar ; Smesny, Stefan ; Hickie, Ian B ; Berger, Gregor ; Chen, Eric Y H ; de Haan, Lieuwe ; Nieman, Dorien H ; Nordentoft, Merete ; Riecher-Rössler, Anita ; Verma, Swapna ; Thompson, Andrew ; Yung, Alison Ruth ; Paul Amminger, G</creatorcontrib><description>Abstract Background Adherence to a medication is generally defined as the extent to which patients take medications as prescribed by their health care providers. Poor adherence to study medication is not uncommon posing a major challenge to treatment trails. However, poor adherence may not be randomly distributed but rather be associated with demographic or illness factors. The aim of the present study was to identify factors associated with adherence to study medication in young people at ultrahigh risk of psychosis who participated in the NEURAPRO study. Methods Secondary analysis of data collected in a multi-centre, double-blind, placebo-controlled, randomized clinical trial to prevent or delay the onset of psychosis in participants at ultrahigh risk of psychosis testing omega-3 polyunsaturated fatty acids (omega-3 PUFAs) vs. placebo, in combination with cognitive behavioural case management (NEURAPRO) were included in this analysis. Measures included the Brief Psychiatric Rating Scale (BPRS), the Scale for the Assessment of Negative Symptoms (SANS), the Montgomery Asberg Depression Rating Scale (MADRS), the Young Mania Rating Scale (YMRS), the Social and Occupational Functioning Assessment Scale (SOFAS), and the Global Functioning: Social and Role scales. Adherence to the study medication was assessed monthly for each participant based on capsule count. The mean adherence rating over the 6-month intervention period was then computed and categorized as either adherent (≤25% of capsules returned) or non-adherent (&gt;25% of capsules returned). Transition to psychosis was defined on the basis of operationalized criteria and assessed with the Comprehensive Assessment of the At-Risk Mental State. Levels of ω-3 PUFAs in fish oil, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (amongst other fatty acids) were measured as percentage of total fatty acids in erythrocytes at baseline and at month 6 (end-of-intervention). Results Of 304 randomised participants, 57.9% (N = 176) were non-adherent (&gt;25% of capsules returned) and 128 (42.1%) were adherent (≤25% capsules returned) to the study medication. No sex differences were observed for adherence rates. At baseline the omega-3 index (EPA+DHA) was significantly lower in the non-adherent group (P = 0.018). The non-adherent group had significant lower scores on the SOFAS (P = 0.001) and the Global Functioning: Social and Role Scale at baseline assessment (P &lt; 0.001 and P = 0.020, respectively) compared to the adherent group. No statistically significant differences were observed on symptom measures at baseline (BPRS, SANS, MADRS, YMRS). The cumulative transition to psychosis rate at month 12 was significantly higher in the non-adherent group compared to the adherent group (14.8% vs. 4.7%; Log rank test: P &lt; 0.001). Discussion Adherence to study medication was relatively low in NEURAPRO. Poor functioning and lower levels of ω-3 PUFAs at baseline were associated with non-adherence. Young people who were non-adherent had a significantly higher risk of progressing to first episode psychosis. Knowledge about factors associated with adherence could help to improve the delivery of interventions in young people at risk of psychosis.</description><identifier>ISSN: 0586-7614</identifier><identifier>EISSN: 1745-1701</identifier><identifier>DOI: 10.1093/schbul/sby016.325</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Abstracts</subject><ispartof>Schizophrenia bulletin, 2018-04, Vol.44 (suppl_1), p.S132-S133</ispartof><rights>Maryland Psychiatric Research Center 2018. 2018</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c2255-32a824f3c64fcd9d6f158462f04b3a47e8c09d1520af51ffdab50623893012883</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5888024/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5888024/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,27924,27925,53791,53793</link.rule.ids></links><search><creatorcontrib>Schlögelhofer, Monika</creatorcontrib><creatorcontrib>McGorry, Patrick D</creatorcontrib><creatorcontrib>Nelson, Barnaby</creatorcontrib><creatorcontrib>Markulev, Connie</creatorcontrib><creatorcontrib>Yuen, Hok Pan</creatorcontrib><creatorcontrib>Schäfer, Miriam</creatorcontrib><creatorcontrib>Mossaheb, Nilufar</creatorcontrib><creatorcontrib>Smesny, Stefan</creatorcontrib><creatorcontrib>Hickie, Ian B</creatorcontrib><creatorcontrib>Berger, Gregor</creatorcontrib><creatorcontrib>Chen, Eric Y H</creatorcontrib><creatorcontrib>de Haan, Lieuwe</creatorcontrib><creatorcontrib>Nieman, Dorien H</creatorcontrib><creatorcontrib>Nordentoft, Merete</creatorcontrib><creatorcontrib>Riecher-Rössler, Anita</creatorcontrib><creatorcontrib>Verma, Swapna</creatorcontrib><creatorcontrib>Thompson, Andrew</creatorcontrib><creatorcontrib>Yung, Alison Ruth</creatorcontrib><creatorcontrib>Paul Amminger, G</creatorcontrib><title>T49. THE NEURAPRO STUDY: ADHERENCE TO STUDY MEDICATION</title><title>Schizophrenia bulletin</title><description>Abstract Background Adherence to a medication is generally defined as the extent to which patients take medications as prescribed by their health care providers. Poor adherence to study medication is not uncommon posing a major challenge to treatment trails. However, poor adherence may not be randomly distributed but rather be associated with demographic or illness factors. The aim of the present study was to identify factors associated with adherence to study medication in young people at ultrahigh risk of psychosis who participated in the NEURAPRO study. Methods Secondary analysis of data collected in a multi-centre, double-blind, placebo-controlled, randomized clinical trial to prevent or delay the onset of psychosis in participants at ultrahigh risk of psychosis testing omega-3 polyunsaturated fatty acids (omega-3 PUFAs) vs. placebo, in combination with cognitive behavioural case management (NEURAPRO) were included in this analysis. Measures included the Brief Psychiatric Rating Scale (BPRS), the Scale for the Assessment of Negative Symptoms (SANS), the Montgomery Asberg Depression Rating Scale (MADRS), the Young Mania Rating Scale (YMRS), the Social and Occupational Functioning Assessment Scale (SOFAS), and the Global Functioning: Social and Role scales. Adherence to the study medication was assessed monthly for each participant based on capsule count. The mean adherence rating over the 6-month intervention period was then computed and categorized as either adherent (≤25% of capsules returned) or non-adherent (&gt;25% of capsules returned). Transition to psychosis was defined on the basis of operationalized criteria and assessed with the Comprehensive Assessment of the At-Risk Mental State. Levels of ω-3 PUFAs in fish oil, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (amongst other fatty acids) were measured as percentage of total fatty acids in erythrocytes at baseline and at month 6 (end-of-intervention). Results Of 304 randomised participants, 57.9% (N = 176) were non-adherent (&gt;25% of capsules returned) and 128 (42.1%) were adherent (≤25% capsules returned) to the study medication. No sex differences were observed for adherence rates. At baseline the omega-3 index (EPA+DHA) was significantly lower in the non-adherent group (P = 0.018). The non-adherent group had significant lower scores on the SOFAS (P = 0.001) and the Global Functioning: Social and Role Scale at baseline assessment (P &lt; 0.001 and P = 0.020, respectively) compared to the adherent group. No statistically significant differences were observed on symptom measures at baseline (BPRS, SANS, MADRS, YMRS). The cumulative transition to psychosis rate at month 12 was significantly higher in the non-adherent group compared to the adherent group (14.8% vs. 4.7%; Log rank test: P &lt; 0.001). Discussion Adherence to study medication was relatively low in NEURAPRO. Poor functioning and lower levels of ω-3 PUFAs at baseline were associated with non-adherence. Young people who were non-adherent had a significantly higher risk of progressing to first episode psychosis. 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THE NEURAPRO STUDY: ADHERENCE TO STUDY MEDICATION</title><author>Schlögelhofer, Monika ; McGorry, Patrick D ; Nelson, Barnaby ; Markulev, Connie ; Yuen, Hok Pan ; Schäfer, Miriam ; Mossaheb, Nilufar ; Smesny, Stefan ; Hickie, Ian B ; Berger, Gregor ; Chen, Eric Y H ; de Haan, Lieuwe ; Nieman, Dorien H ; Nordentoft, Merete ; Riecher-Rössler, Anita ; Verma, Swapna ; Thompson, Andrew ; Yung, Alison Ruth ; Paul Amminger, G</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c2255-32a824f3c64fcd9d6f158462f04b3a47e8c09d1520af51ffdab50623893012883</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Abstracts</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Schlögelhofer, Monika</creatorcontrib><creatorcontrib>McGorry, Patrick D</creatorcontrib><creatorcontrib>Nelson, Barnaby</creatorcontrib><creatorcontrib>Markulev, Connie</creatorcontrib><creatorcontrib>Yuen, Hok Pan</creatorcontrib><creatorcontrib>Schäfer, Miriam</creatorcontrib><creatorcontrib>Mossaheb, Nilufar</creatorcontrib><creatorcontrib>Smesny, Stefan</creatorcontrib><creatorcontrib>Hickie, Ian B</creatorcontrib><creatorcontrib>Berger, Gregor</creatorcontrib><creatorcontrib>Chen, Eric Y H</creatorcontrib><creatorcontrib>de Haan, Lieuwe</creatorcontrib><creatorcontrib>Nieman, Dorien H</creatorcontrib><creatorcontrib>Nordentoft, Merete</creatorcontrib><creatorcontrib>Riecher-Rössler, Anita</creatorcontrib><creatorcontrib>Verma, Swapna</creatorcontrib><creatorcontrib>Thompson, Andrew</creatorcontrib><creatorcontrib>Yung, Alison Ruth</creatorcontrib><creatorcontrib>Paul Amminger, G</creatorcontrib><collection>Oxford Open</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Schizophrenia bulletin</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Schlögelhofer, Monika</au><au>McGorry, Patrick D</au><au>Nelson, Barnaby</au><au>Markulev, Connie</au><au>Yuen, Hok Pan</au><au>Schäfer, Miriam</au><au>Mossaheb, Nilufar</au><au>Smesny, Stefan</au><au>Hickie, Ian B</au><au>Berger, Gregor</au><au>Chen, Eric Y H</au><au>de Haan, Lieuwe</au><au>Nieman, Dorien H</au><au>Nordentoft, Merete</au><au>Riecher-Rössler, Anita</au><au>Verma, Swapna</au><au>Thompson, Andrew</au><au>Yung, Alison Ruth</au><au>Paul Amminger, G</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>T49. THE NEURAPRO STUDY: ADHERENCE TO STUDY MEDICATION</atitle><jtitle>Schizophrenia bulletin</jtitle><date>2018-04-01</date><risdate>2018</risdate><volume>44</volume><issue>suppl_1</issue><spage>S132</spage><epage>S133</epage><pages>S132-S133</pages><issn>0586-7614</issn><eissn>1745-1701</eissn><abstract>Abstract Background Adherence to a medication is generally defined as the extent to which patients take medications as prescribed by their health care providers. Poor adherence to study medication is not uncommon posing a major challenge to treatment trails. However, poor adherence may not be randomly distributed but rather be associated with demographic or illness factors. The aim of the present study was to identify factors associated with adherence to study medication in young people at ultrahigh risk of psychosis who participated in the NEURAPRO study. Methods Secondary analysis of data collected in a multi-centre, double-blind, placebo-controlled, randomized clinical trial to prevent or delay the onset of psychosis in participants at ultrahigh risk of psychosis testing omega-3 polyunsaturated fatty acids (omega-3 PUFAs) vs. placebo, in combination with cognitive behavioural case management (NEURAPRO) were included in this analysis. Measures included the Brief Psychiatric Rating Scale (BPRS), the Scale for the Assessment of Negative Symptoms (SANS), the Montgomery Asberg Depression Rating Scale (MADRS), the Young Mania Rating Scale (YMRS), the Social and Occupational Functioning Assessment Scale (SOFAS), and the Global Functioning: Social and Role scales. Adherence to the study medication was assessed monthly for each participant based on capsule count. The mean adherence rating over the 6-month intervention period was then computed and categorized as either adherent (≤25% of capsules returned) or non-adherent (&gt;25% of capsules returned). Transition to psychosis was defined on the basis of operationalized criteria and assessed with the Comprehensive Assessment of the At-Risk Mental State. Levels of ω-3 PUFAs in fish oil, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (amongst other fatty acids) were measured as percentage of total fatty acids in erythrocytes at baseline and at month 6 (end-of-intervention). Results Of 304 randomised participants, 57.9% (N = 176) were non-adherent (&gt;25% of capsules returned) and 128 (42.1%) were adherent (≤25% capsules returned) to the study medication. No sex differences were observed for adherence rates. At baseline the omega-3 index (EPA+DHA) was significantly lower in the non-adherent group (P = 0.018). The non-adherent group had significant lower scores on the SOFAS (P = 0.001) and the Global Functioning: Social and Role Scale at baseline assessment (P &lt; 0.001 and P = 0.020, respectively) compared to the adherent group. No statistically significant differences were observed on symptom measures at baseline (BPRS, SANS, MADRS, YMRS). The cumulative transition to psychosis rate at month 12 was significantly higher in the non-adherent group compared to the adherent group (14.8% vs. 4.7%; Log rank test: P &lt; 0.001). Discussion Adherence to study medication was relatively low in NEURAPRO. Poor functioning and lower levels of ω-3 PUFAs at baseline were associated with non-adherence. Young people who were non-adherent had a significantly higher risk of progressing to first episode psychosis. Knowledge about factors associated with adherence could help to improve the delivery of interventions in young people at risk of psychosis.</abstract><cop>US</cop><pub>Oxford University Press</pub><doi>10.1093/schbul/sby016.325</doi><oa>free_for_read</oa></addata></record>
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title T49. THE NEURAPRO STUDY: ADHERENCE TO STUDY MEDICATION
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