Wordless intervention for people with epilepsy and learning disabilities (WIELD): a randomised controlled feasibility trial
ObjectiveTo investigate the feasibility of a full-scale randomised controlled trial of a picture booklet to improve quality of life for people with epilepsy and learning disabilities.Trial designA randomised controlled feasibility trial. Randomisation was not blinded and was conducted using a centra...
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| Veröffentlicht in: | BMJ open 2016-11, Vol.6 (11), p.e012993 |
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| creator | Mengoni, Silvana E Gates, Bob Parkes, Georgina Wellsted, David Barton, Garry Ring, Howard Khoo, Mary Ellen Monji-Patel, Deela Friedli, Karin Zia, Asif Irvine, Lisa Durand, Marie-Anne |
| description | ObjectiveTo investigate the feasibility of a full-scale randomised controlled trial of a picture booklet to improve quality of life for people with epilepsy and learning disabilities.Trial designA randomised controlled feasibility trial. Randomisation was not blinded and was conducted using a centralised secure database and a blocked 1:1 allocation ratio.SettingEpilepsy clinics in 1 English National Health Service (NHS) Trust.ParticipantsPatients with learning disabilities and epilepsy who had: a seizure within the past 12 months, meaningful communication and a carer with sufficient proficiency in English.InterventionParticipants in the intervention group used a picture booklet with a trained researcher, and a carer present. These participants kept the booklet, and were asked to use it at least twice more over 20 weeks. The control group received treatment as usual, and were provided with a booklet at the end of the study.Outcome measures7 feasibility criteria were used relating to recruitment, data collection, attrition, potential effect on epilepsy-related quality of life (Epilepsy and Learning Disabilities Quality of Life Scale, ELDQOL) at 4-week, 12-week and 20-week follow-ups, feasibility of methodology, acceptability of the intervention and potential to calculate cost-effectiveness.OutcomeThe recruitment rate of eligible patients was 34% and the target of 40 participants was reached. There was minimal missing data and attrition. An intention-to-treat analysis was performed; data from the outcome measures suggest a benefit from the intervention on the ELDQOL behaviour and mood subscales at 4 and 20 weeks follow-up. The booklet and study methods were positively received, and no adverse events were reported. There was a positive indication of the potential for a cost-effectiveness analysis.ConclusionsAll feasibility criteria were fully or partially met, therefore confirming feasibility of a definitive trial.Trial registration numberISRCTN80067039. |
| doi_str_mv | 10.1136/bmjopen-2016-012993 |
| format | Article |
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Randomisation was not blinded and was conducted using a centralised secure database and a blocked 1:1 allocation ratio.SettingEpilepsy clinics in 1 English National Health Service (NHS) Trust.ParticipantsPatients with learning disabilities and epilepsy who had: a seizure within the past 12 months, meaningful communication and a carer with sufficient proficiency in English.InterventionParticipants in the intervention group used a picture booklet with a trained researcher, and a carer present. These participants kept the booklet, and were asked to use it at least twice more over 20 weeks. The control group received treatment as usual, and were provided with a booklet at the end of the study.Outcome measures7 feasibility criteria were used relating to recruitment, data collection, attrition, potential effect on epilepsy-related quality of life (Epilepsy and Learning Disabilities Quality of Life Scale, ELDQOL) at 4-week, 12-week and 20-week follow-ups, feasibility of methodology, acceptability of the intervention and potential to calculate cost-effectiveness.OutcomeThe recruitment rate of eligible patients was 34% and the target of 40 participants was reached. There was minimal missing data and attrition. An intention-to-treat analysis was performed; data from the outcome measures suggest a benefit from the intervention on the ELDQOL behaviour and mood subscales at 4 and 20 weeks follow-up. The booklet and study methods were positively received, and no adverse events were reported. There was a positive indication of the potential for a cost-effectiveness analysis.ConclusionsAll feasibility criteria were fully or partially met, therefore confirming feasibility of a definitive trial.Trial registration numberISRCTN80067039.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2016-012993</identifier><identifier>PMID: 28186943</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Adult ; Caregivers ; Convulsions & seizures ; Cost-Benefit Analysis ; Disability ; Empowerment ; Epilepsy ; Epilepsy - complications ; Feasibility Studies ; Female ; Health Services Research ; Humans ; Intervention ; Learning disabilities ; Learning Disabilities - complications ; Learning Disabilities - therapy ; Male ; Medical personnel ; Middle Aged ; Patient Education as Topic ; Patients ; Population ; Quality of Life ; Questionnaires ; Severity of Illness Index ; Surveys and Questionnaires ; Time Factors ; Treatment Outcome ; United Kingdom ; Verbal communication</subject><ispartof>BMJ open, 2016-11, Vol.6 (11), p.e012993</ispartof><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing</rights><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.</rights><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ 2016 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://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>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b472t-174158e7e51df0ad0fefc31a3c864c1dad34493cd3a09f37f50e52e6d3d74e643</citedby><cites>FETCH-LOGICAL-b472t-174158e7e51df0ad0fefc31a3c864c1dad34493cd3a09f37f50e52e6d3d74e643</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttp://bmjopen.bmj.com/content/6/11/e012993.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttp://bmjopen.bmj.com/content/6/11/e012993.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,27548,27549,27923,27924,53790,53792,77372,77403</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28186943$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mengoni, Silvana E</creatorcontrib><creatorcontrib>Gates, Bob</creatorcontrib><creatorcontrib>Parkes, Georgina</creatorcontrib><creatorcontrib>Wellsted, David</creatorcontrib><creatorcontrib>Barton, Garry</creatorcontrib><creatorcontrib>Ring, Howard</creatorcontrib><creatorcontrib>Khoo, Mary Ellen</creatorcontrib><creatorcontrib>Monji-Patel, Deela</creatorcontrib><creatorcontrib>Friedli, Karin</creatorcontrib><creatorcontrib>Zia, Asif</creatorcontrib><creatorcontrib>Irvine, Lisa</creatorcontrib><creatorcontrib>Durand, Marie-Anne</creatorcontrib><title>Wordless intervention for people with epilepsy and learning disabilities (WIELD): a randomised controlled feasibility trial</title><title>BMJ open</title><addtitle>BMJ Open</addtitle><description>ObjectiveTo investigate the feasibility of a full-scale randomised controlled trial of a picture booklet to improve quality of life for people with epilepsy and learning disabilities.Trial designA randomised controlled feasibility trial. Randomisation was not blinded and was conducted using a centralised secure database and a blocked 1:1 allocation ratio.SettingEpilepsy clinics in 1 English National Health Service (NHS) Trust.ParticipantsPatients with learning disabilities and epilepsy who had: a seizure within the past 12 months, meaningful communication and a carer with sufficient proficiency in English.InterventionParticipants in the intervention group used a picture booklet with a trained researcher, and a carer present. These participants kept the booklet, and were asked to use it at least twice more over 20 weeks. The control group received treatment as usual, and were provided with a booklet at the end of the study.Outcome measures7 feasibility criteria were used relating to recruitment, data collection, attrition, potential effect on epilepsy-related quality of life (Epilepsy and Learning Disabilities Quality of Life Scale, ELDQOL) at 4-week, 12-week and 20-week follow-ups, feasibility of methodology, acceptability of the intervention and potential to calculate cost-effectiveness.OutcomeThe recruitment rate of eligible patients was 34% and the target of 40 participants was reached. There was minimal missing data and attrition. An intention-to-treat analysis was performed; data from the outcome measures suggest a benefit from the intervention on the ELDQOL behaviour and mood subscales at 4 and 20 weeks follow-up. The booklet and study methods were positively received, and no adverse events were reported. There was a positive indication of the potential for a cost-effectiveness analysis.ConclusionsAll feasibility criteria were fully or partially met, therefore confirming feasibility of a definitive trial.Trial registration numberISRCTN80067039.</description><subject>Adult</subject><subject>Caregivers</subject><subject>Convulsions & seizures</subject><subject>Cost-Benefit Analysis</subject><subject>Disability</subject><subject>Empowerment</subject><subject>Epilepsy</subject><subject>Epilepsy - complications</subject><subject>Feasibility Studies</subject><subject>Female</subject><subject>Health Services Research</subject><subject>Humans</subject><subject>Intervention</subject><subject>Learning disabilities</subject><subject>Learning Disabilities - complications</subject><subject>Learning Disabilities - therapy</subject><subject>Male</subject><subject>Medical personnel</subject><subject>Middle Aged</subject><subject>Patient Education as Topic</subject><subject>Patients</subject><subject>Population</subject><subject>Quality of Life</subject><subject>Questionnaires</subject><subject>Severity of Illness Index</subject><subject>Surveys and Questionnaires</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>United Kingdom</subject><subject>Verbal communication</subject><issn>2044-6055</issn><issn>2044-6055</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>9YT</sourceid><sourceid>ACMMV</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNqNkUtLJDEUhYMoKuovECQwG12UJpWkHrMQxDc0uFFchnTlRtOkk5qkWmn886btVnRWZpML-c4h5x6E9ik5ppRVJ-PpJPTgi5LQqiC0bFu2hrZLwnlRESHWv81baC-lCcmHi1aIchNtlQ1tqpazbfT2GKJ2kBK2foD4An6wwWMTIu4h9A7wqx2eMfTWQZ_mWHmNHajorX_C2iY1ts4OFhI-fLy9HF0c_cUKx0yFqU2gcRf8EINzeTSgkv3A53iIVrldtGGUS7C3unfQw9Xl_flNMbq7vj0_GxVjXpdDQWtORQM1CKoNUZoYMB2jinVNxTuqlWact6zTTJHWsNoIAqKESjNdc6g420GnS99-Np6C7nLGqJzso52qOJdBWfnzxdtn-RRepKBl07QLg8OVQQz_ZpAGmcN14JzyEGZJ5mXWebGck4z--Q-dhFn0OV6mWN3mFpoFxZZUF0NKEczXZyiRi37lql-56Fcu-82qg-85vjSfbWbgeAlk9a8c3wHU-bQ8</recordid><startdate>20161110</startdate><enddate>20161110</enddate><creator>Mengoni, Silvana E</creator><creator>Gates, Bob</creator><creator>Parkes, Georgina</creator><creator>Wellsted, David</creator><creator>Barton, Garry</creator><creator>Ring, Howard</creator><creator>Khoo, Mary Ellen</creator><creator>Monji-Patel, Deela</creator><creator>Friedli, Karin</creator><creator>Zia, Asif</creator><creator>Irvine, Lisa</creator><creator>Durand, Marie-Anne</creator><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group</general><scope>9YT</scope><scope>ACMMV</scope><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>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20161110</creationdate><title>Wordless intervention for people with epilepsy and learning disabilities (WIELD): a randomised controlled feasibility trial</title><author>Mengoni, Silvana E ; Gates, Bob ; Parkes, Georgina ; Wellsted, David ; Barton, Garry ; Ring, Howard ; Khoo, Mary Ellen ; Monji-Patel, Deela ; Friedli, Karin ; Zia, Asif ; Irvine, Lisa ; Durand, Marie-Anne</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b472t-174158e7e51df0ad0fefc31a3c864c1dad34493cd3a09f37f50e52e6d3d74e643</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adult</topic><topic>Caregivers</topic><topic>Convulsions & seizures</topic><topic>Cost-Benefit Analysis</topic><topic>Disability</topic><topic>Empowerment</topic><topic>Epilepsy</topic><topic>Epilepsy - complications</topic><topic>Feasibility Studies</topic><topic>Female</topic><topic>Health Services Research</topic><topic>Humans</topic><topic>Intervention</topic><topic>Learning disabilities</topic><topic>Learning Disabilities - complications</topic><topic>Learning Disabilities - therapy</topic><topic>Male</topic><topic>Medical personnel</topic><topic>Middle Aged</topic><topic>Patient Education as Topic</topic><topic>Patients</topic><topic>Population</topic><topic>Quality of Life</topic><topic>Questionnaires</topic><topic>Severity of Illness Index</topic><topic>Surveys and Questionnaires</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>United Kingdom</topic><topic>Verbal communication</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mengoni, Silvana E</creatorcontrib><creatorcontrib>Gates, Bob</creatorcontrib><creatorcontrib>Parkes, Georgina</creatorcontrib><creatorcontrib>Wellsted, David</creatorcontrib><creatorcontrib>Barton, Garry</creatorcontrib><creatorcontrib>Ring, Howard</creatorcontrib><creatorcontrib>Khoo, Mary Ellen</creatorcontrib><creatorcontrib>Monji-Patel, Deela</creatorcontrib><creatorcontrib>Friedli, Karin</creatorcontrib><creatorcontrib>Zia, Asif</creatorcontrib><creatorcontrib>Irvine, Lisa</creatorcontrib><creatorcontrib>Durand, Marie-Anne</creatorcontrib><collection>BMJ Open Access Journals</collection><collection>BMJ Journals:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Psychology Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMJ open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mengoni, Silvana E</au><au>Gates, Bob</au><au>Parkes, Georgina</au><au>Wellsted, David</au><au>Barton, Garry</au><au>Ring, Howard</au><au>Khoo, Mary Ellen</au><au>Monji-Patel, Deela</au><au>Friedli, Karin</au><au>Zia, Asif</au><au>Irvine, Lisa</au><au>Durand, Marie-Anne</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Wordless intervention for people with epilepsy and learning disabilities (WIELD): a randomised controlled feasibility trial</atitle><jtitle>BMJ open</jtitle><addtitle>BMJ Open</addtitle><date>2016-11-10</date><risdate>2016</risdate><volume>6</volume><issue>11</issue><spage>e012993</spage><pages>e012993-</pages><issn>2044-6055</issn><eissn>2044-6055</eissn><abstract>ObjectiveTo investigate the feasibility of a full-scale randomised controlled trial of a picture booklet to improve quality of life for people with epilepsy and learning disabilities.Trial designA randomised controlled feasibility trial. Randomisation was not blinded and was conducted using a centralised secure database and a blocked 1:1 allocation ratio.SettingEpilepsy clinics in 1 English National Health Service (NHS) Trust.ParticipantsPatients with learning disabilities and epilepsy who had: a seizure within the past 12 months, meaningful communication and a carer with sufficient proficiency in English.InterventionParticipants in the intervention group used a picture booklet with a trained researcher, and a carer present. These participants kept the booklet, and were asked to use it at least twice more over 20 weeks. The control group received treatment as usual, and were provided with a booklet at the end of the study.Outcome measures7 feasibility criteria were used relating to recruitment, data collection, attrition, potential effect on epilepsy-related quality of life (Epilepsy and Learning Disabilities Quality of Life Scale, ELDQOL) at 4-week, 12-week and 20-week follow-ups, feasibility of methodology, acceptability of the intervention and potential to calculate cost-effectiveness.OutcomeThe recruitment rate of eligible patients was 34% and the target of 40 participants was reached. There was minimal missing data and attrition. An intention-to-treat analysis was performed; data from the outcome measures suggest a benefit from the intervention on the ELDQOL behaviour and mood subscales at 4 and 20 weeks follow-up. The booklet and study methods were positively received, and no adverse events were reported. There was a positive indication of the potential for a cost-effectiveness analysis.ConclusionsAll feasibility criteria were fully or partially met, therefore confirming feasibility of a definitive trial.Trial registration numberISRCTN80067039.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>28186943</pmid><doi>10.1136/bmjopen-2016-012993</doi><oa>free_for_read</oa></addata></record> |
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| source | BMJ Open Access Journals; MEDLINE; DOAJ Directory of Open Access Journals; PubMed Central Open Access; EZB-FREE-00999 freely available EZB journals; PubMed Central |
| subjects | Adult Caregivers Convulsions & seizures Cost-Benefit Analysis Disability Empowerment Epilepsy Epilepsy - complications Feasibility Studies Female Health Services Research Humans Intervention Learning disabilities Learning Disabilities - complications Learning Disabilities - therapy Male Medical personnel Middle Aged Patient Education as Topic Patients Population Quality of Life Questionnaires Severity of Illness Index Surveys and Questionnaires Time Factors Treatment Outcome United Kingdom Verbal communication |
| title | Wordless intervention for people with epilepsy and learning disabilities (WIELD): a randomised controlled feasibility trial |
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