Podoconiosis treatment in northern Ethiopia (GoLBet): study protocol for a randomised controlled trial.
Identifieur interne : 000D71 ( PubMed/Corpus ); précédent : 000D70; suivant : 000D72Podoconiosis treatment in northern Ethiopia (GoLBet): study protocol for a randomised controlled trial.
Auteurs : Henok Negussie ; Meseret Molla Kassahun ; Greg Fegan ; Patricia Njuguna ; Fikre Enquselassie ; Andy Mckay ; Melanie Newport ; Trudie Lang ; Gail DaveySource :
- Trials [ 1745-6215 ] ; 2015.
English descriptors
- KwdEn :
- Acute Disease, Bandages, Clinical Protocols, Cost of Illness, Disability Evaluation, Elephantiasis (diagnosis), Elephantiasis (physiopathology), Elephantiasis (psychology), Elephantiasis (therapy), Ethiopia, Exercise Therapy, Health Knowledge, Attitudes, Practice, Humans, Hygiene, Informed Consent, Neglected Diseases (diagnosis), Neglected Diseases (physiopathology), Neglected Diseases (psychology), Neglected Diseases (therapy), Patient Compliance, Patient Education as Topic, Prejudice (psychology), Quality of Life, Research Design, Self Care, Self Report, Severity of Illness Index, Shoes, Stereotyping, Time Factors, Time-to-Treatment, Treatment Outcome.
- MESH :
- geographic : Ethiopia.
- diagnosis : Elephantiasis, Neglected Diseases.
- physiopathology : Elephantiasis, Neglected Diseases.
- psychology : Elephantiasis, Neglected Diseases, Prejudice.
- therapy : Elephantiasis, Neglected Diseases.
- Acute Disease, Bandages, Clinical Protocols, Cost of Illness, Disability Evaluation, Exercise Therapy, Health Knowledge, Attitudes, Practice, Humans, Hygiene, Informed Consent, Patient Compliance, Patient Education as Topic, Quality of Life, Research Design, Self Care, Self Report, Severity of Illness Index, Shoes, Stereotyping, Time Factors, Time-to-Treatment, Treatment Outcome.
Abstract
Podoconiosis is one of the forgotten types of leg swelling (elephantiasis) in the tropics. Unlike the other, better-known types of leg swelling, podoconiosis is not caused by any parasite, virus or bacterium, but by an abnormal reaction to minerals found in the clay soils of some tropical highland areas. Non-governmental Organizations (NGOs) have been responsible for the development of simple treatment methods without systematic evaluation of its effectiveness. It is essential that a large scale, fully controlled, pragmatic trial of the intervention is conducted. We aim to test the hypothesis that community-based treatment of podoconiosis lymphoedema reduces the frequency of acute dermatolymphangioadenitis episodes ('acute attacks') and improves other clinical, social and economic outcomes.
DOI: 10.1186/s13063-015-0818-7
PubMed: 26177812
Links to Exploration step
pubmed:26177812Le document en format XML
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H.Seifu@bsms.ac.uk.</nlm:affiliation></affiliation></author><author><name sortKey="Kassahun, Meseret Molla" sort="Kassahun, Meseret Molla" uniqKey="Kassahun M" first="Meseret Molla" last="Kassahun">Meseret Molla Kassahun</name><affiliation><nlm:affiliation>College of Development Studies, Addis Ababa University, Addis Ababa, Ethiopia. mesenana_03@yahoo.com.</nlm:affiliation></affiliation></author><author><name sortKey="Fegan, Greg" sort="Fegan, Greg" uniqKey="Fegan G" first="Greg" last="Fegan">Greg Fegan</name><affiliation><nlm:affiliation>Oxford University Centre for Tropical Medicine, Oxford, UK. GFegan@kemri-wellcome.org.</nlm:affiliation></affiliation></author><author><name sortKey="Njuguna, Patricia" sort="Njuguna, Patricia" uniqKey="Njuguna P" first="Patricia" last="Njuguna">Patricia Njuguna</name><affiliation><nlm:affiliation>Kenya Medical Research Institute-Wellcome Trust Research Programme (KWTRP), Kilifi, Kenya. PNjuguna@kemri-wellcome.org.</nlm:affiliation></affiliation></author><author><name sortKey="Enquselassie, Fikre" sort="Enquselassie, Fikre" uniqKey="Enquselassie F" first="Fikre" last="Enquselassie">Fikre Enquselassie</name><affiliation><nlm:affiliation>School of Public Health, Addis Ababa University, Addis Ababa, Ethiopia. fikreens@yahoo.com.</nlm:affiliation></affiliation></author><author><name sortKey="Mckay, Andy" sort="Mckay, Andy" uniqKey="Mckay A" first="Andy" last="Mckay">Andy Mckay</name><affiliation><nlm:affiliation>Department of Economics, University of Sussex, Falmer, Brighton, BN1 9SL, UK. A.Mckay@sussex.ac.uk.</nlm:affiliation></affiliation></author><author><name sortKey="Newport, Melanie" sort="Newport, Melanie" uniqKey="Newport M" first="Melanie" last="Newport">Melanie Newport</name><affiliation><nlm:affiliation>Brighton & Sussex Medical School, University of Sussex, Falmer, Brighton, BN1 9PX, UK. 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H.Seifu@bsms.ac.uk.</nlm:affiliation></affiliation></author><author><name sortKey="Kassahun, Meseret Molla" sort="Kassahun, Meseret Molla" uniqKey="Kassahun M" first="Meseret Molla" last="Kassahun">Meseret Molla Kassahun</name><affiliation><nlm:affiliation>College of Development Studies, Addis Ababa University, Addis Ababa, Ethiopia. mesenana_03@yahoo.com.</nlm:affiliation></affiliation></author><author><name sortKey="Fegan, Greg" sort="Fegan, Greg" uniqKey="Fegan G" first="Greg" last="Fegan">Greg Fegan</name><affiliation><nlm:affiliation>Oxford University Centre for Tropical Medicine, Oxford, UK. GFegan@kemri-wellcome.org.</nlm:affiliation></affiliation></author><author><name sortKey="Njuguna, Patricia" sort="Njuguna, Patricia" uniqKey="Njuguna P" first="Patricia" last="Njuguna">Patricia Njuguna</name><affiliation><nlm:affiliation>Kenya Medical Research Institute-Wellcome Trust Research Programme (KWTRP), Kilifi, Kenya. PNjuguna@kemri-wellcome.org.</nlm:affiliation></affiliation></author><author><name sortKey="Enquselassie, Fikre" sort="Enquselassie, Fikre" uniqKey="Enquselassie F" first="Fikre" last="Enquselassie">Fikre Enquselassie</name><affiliation><nlm:affiliation>School of Public Health, Addis Ababa University, Addis Ababa, Ethiopia. fikreens@yahoo.com.</nlm:affiliation></affiliation></author><author><name sortKey="Mckay, Andy" sort="Mckay, Andy" uniqKey="Mckay A" first="Andy" last="Mckay">Andy Mckay</name><affiliation><nlm:affiliation>Department of Economics, University of Sussex, Falmer, Brighton, BN1 9SL, UK. A.Mckay@sussex.ac.uk.</nlm:affiliation></affiliation></author><author><name sortKey="Newport, Melanie" sort="Newport, Melanie" uniqKey="Newport M" first="Melanie" last="Newport">Melanie Newport</name><affiliation><nlm:affiliation>Brighton & Sussex Medical School, University of Sussex, Falmer, Brighton, BN1 9PX, UK. M.J.Newport@bsms.ac.uk.</nlm:affiliation></affiliation></author><author><name sortKey="Lang, Trudie" sort="Lang, Trudie" uniqKey="Lang T" first="Trudie" last="Lang">Trudie Lang</name><affiliation><nlm:affiliation>Oxford University Centre for Tropical Medicine, Oxford, UK. trudie.lang@ndm.ox.ac.uk.</nlm:affiliation></affiliation></author><author><name sortKey="Davey, Gail" sort="Davey, Gail" uniqKey="Davey G" first="Gail" last="Davey">Gail Davey</name><affiliation><nlm:affiliation>Brighton & Sussex Medical School, University of Sussex, Falmer, Brighton, BN1 9PX, UK. G.Davey@bsms.ac.uk.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Acute Disease</term><term>Bandages</term><term>Clinical Protocols</term><term>Cost of Illness</term><term>Disability Evaluation</term><term>Elephantiasis (diagnosis)</term><term>Elephantiasis (physiopathology)</term><term>Elephantiasis (psychology)</term><term>Elephantiasis (therapy)</term><term>Ethiopia</term><term>Exercise Therapy</term><term>Health Knowledge, Attitudes, Practice</term><term>Humans</term><term>Hygiene</term><term>Informed Consent</term><term>Neglected Diseases (diagnosis)</term><term>Neglected Diseases (physiopathology)</term><term>Neglected Diseases (psychology)</term><term>Neglected Diseases (therapy)</term><term>Patient Compliance</term><term>Patient Education as Topic</term><term>Prejudice (psychology)</term><term>Quality of Life</term><term>Research Design</term><term>Self Care</term><term>Self Report</term><term>Severity of Illness Index</term><term>Shoes</term><term>Stereotyping</term><term>Time Factors</term><term>Time-to-Treatment</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>Ethiopia</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Elephantiasis</term><term>Neglected Diseases</term></keywords><keywords scheme="MESH" qualifier="physiopathology" xml:lang="en"><term>Elephantiasis</term><term>Neglected Diseases</term></keywords><keywords scheme="MESH" qualifier="psychology" xml:lang="en"><term>Elephantiasis</term><term>Neglected Diseases</term><term>Prejudice</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Elephantiasis</term><term>Neglected Diseases</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Acute Disease</term><term>Bandages</term><term>Clinical Protocols</term><term>Cost of Illness</term><term>Disability Evaluation</term><term>Exercise Therapy</term><term>Health Knowledge, Attitudes, Practice</term><term>Humans</term><term>Hygiene</term><term>Informed Consent</term><term>Patient Compliance</term><term>Patient Education as Topic</term><term>Quality of Life</term><term>Research Design</term><term>Self Care</term><term>Self Report</term><term>Severity of Illness Index</term><term>Shoes</term><term>Stereotyping</term><term>Time Factors</term><term>Time-to-Treatment</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Podoconiosis is one of the forgotten types of leg swelling (elephantiasis) in the tropics. Unlike the other, better-known types of leg swelling, podoconiosis is not caused by any parasite, virus or bacterium, but by an abnormal reaction to minerals found in the clay soils of some tropical highland areas. Non-governmental Organizations (NGOs) have been responsible for the development of simple treatment methods without systematic evaluation of its effectiveness. It is essential that a large scale, fully controlled, pragmatic trial of the intervention is conducted. We aim to test the hypothesis that community-based treatment of podoconiosis lymphoedema reduces the frequency of acute dermatolymphangioadenitis episodes ('acute attacks') and improves other clinical, social and economic outcomes.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26177812</PMID><DateCreated><Year>2015</Year><Month>07</Month><Day>16</Day></DateCreated><DateCompleted><Year>2016</Year><Month>04</Month><Day>14</Day></DateCompleted><DateRevised><Year>2017</Year><Month>09</Month><Day>02</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1745-6215</ISSN><JournalIssue CitedMedium="Internet"><Volume>16</Volume><PubDate><Year>2015</Year><Month>Jul</Month><Day>16</Day></PubDate></JournalIssue><Title>Trials</Title><ISOAbbreviation>Trials</ISOAbbreviation></Journal><ArticleTitle>Podoconiosis treatment in northern Ethiopia (GoLBet): study protocol for a randomised controlled trial.</ArticleTitle><Pagination><MedlinePgn>307</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/s13063-015-0818-7</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Podoconiosis is one of the forgotten types of leg swelling (elephantiasis) in the tropics. Unlike the other, better-known types of leg swelling, podoconiosis is not caused by any parasite, virus or bacterium, but by an abnormal reaction to minerals found in the clay soils of some tropical highland areas. Non-governmental Organizations (NGOs) have been responsible for the development of simple treatment methods without systematic evaluation of its effectiveness. It is essential that a large scale, fully controlled, pragmatic trial of the intervention is conducted. We aim to test the hypothesis that community-based treatment of podoconiosis lymphoedema reduces the frequency of acute dermatolymphangioadenitis episodes ('acute attacks') and improves other clinical, social and economic outcomes.</AbstractText><AbstractText Label="METHODS/DESIGN" NlmCategory="METHODS">This is a pragmatic, individually randomised controlled trial. We plan to randomly allocate 680 podoconiosis patients from the East Gojjam Zone in northern Ethiopia to one of two groups: 'Standard Treatment' or 'Delayed Treatment'. Those randomised to standard treatment will receive the hygiene and foot-care intervention from May 2015 for one year, whereas those in the control arm will be followed through 2015 and be offered the intervention in 2016. The trial will be preceded by an economic context survey and a Rapid Ethical Assessment to identify optimal methods of conveying information about the trial and the approaches to obtaining informed consent preferred by the community. The primary outcome will be measured by recording patient recall and using a simple, patient-held diary that will be developed to record episodes of acute attacks. Adherence to treatment, clinical stage of disease, quality of life, disability and stigma will be considered secondary outcome measures. Other outcomes will include adverse events and economic productivity. Assessments will be made at baseline and at 3, 6, 9 and 12 months thereafter.</AbstractText><AbstractText Label="DISCUSSION" NlmCategory="CONCLUSIONS">The evidence is highly likely to inform implementation of the new master plan for integrated control of Neglected Tropical Diseases (NTDs), in which podoconiosis is identified as one of eight NTDs prioritised for control. Potentially, an estimated 3 million patients in Ethiopia will therefore benefit from the results of this trial.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">International Standard Randomised Controlled Trial Number.</AbstractText><AbstractText Label="REGISTRATION NUMBER" NlmCategory="BACKGROUND">ISRCTN67805210. Date of registration: 24 January 2013.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Negussie</LastName><ForeName>Henok</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Brighton & Sussex Medical School, University of Sussex, Falmer, Brighton, BN1 9PX, UK. H.Seifu@bsms.ac.uk.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kassahun</LastName><ForeName>Meseret Molla</ForeName><Initials>MM</Initials><AffiliationInfo><Affiliation>College of Development Studies, Addis Ababa University, Addis Ababa, Ethiopia. mesenana_03@yahoo.com.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Statistics, University of Gondar, Gondar, Ethiopia. mesenana_03@yahoo.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fegan</LastName><ForeName>Greg</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Oxford University Centre for Tropical Medicine, Oxford, UK. GFegan@kemri-wellcome.org.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Kenya Medical Research Institute-Wellcome Trust Research Programme (KWTRP), Kilifi, Kenya. GFegan@kemri-wellcome.org.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Njuguna</LastName><ForeName>Patricia</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Kenya Medical Research Institute-Wellcome Trust Research Programme (KWTRP), Kilifi, Kenya. PNjuguna@kemri-wellcome.org.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Enquselassie</LastName><ForeName>Fikre</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>School of Public Health, Addis Ababa University, Addis Ababa, Ethiopia. fikreens@yahoo.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>McKay</LastName><ForeName>Andy</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Economics, University of Sussex, Falmer, Brighton, BN1 9SL, UK. A.Mckay@sussex.ac.uk.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Newport</LastName><ForeName>Melanie</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Brighton & Sussex Medical School, University of Sussex, Falmer, Brighton, BN1 9PX, UK. M.J.Newport@bsms.ac.uk.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lang</LastName><ForeName>Trudie</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Oxford University Centre for Tropical Medicine, Oxford, UK. trudie.lang@ndm.ox.ac.uk.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Davey</LastName><ForeName>Gail</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Brighton & Sussex Medical School, University of Sussex, Falmer, Brighton, BN1 9PX, UK. G.Davey@bsms.ac.uk.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ISRCTN</DataBankName><AccessionNumberList><AccessionNumber>ISRCTN67805210</AccessionNumber></AccessionNumberList></DataBank></DataBankList><GrantList CompleteYN="Y"><Grant><GrantID>WT092654</GrantID><Agency>Wellcome Trust</Agency><Country>United Kingdom</Country></Grant><Grant><GrantID>WT100715</GrantID><Agency>Wellcome Trust</Agency><Country>United Kingdom</Country></Grant><Grant><GrantID>MR/K007211/1</GrantID><Agency>Medical Research Council</Agency><Country>United Kingdom</Country></Grant><Grant><Agency>Wellcome Trust</Agency><Country>United Kingdom</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D065007">Pragmatic Clinical Trial</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>07</Month><Day>16</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Trials</MedlineTA><NlmUniqueID>101263253</NlmUniqueID><ISSNLinking>1745-6215</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Trop Med Int Health. 2006 Jul;11(7):1136-44</RefSource><PMID Version="1">16827714</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Int Health. 2011 Sep;3(3):176-81</RefSource><PMID Version="1">24038367</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Br J Dermatol. 2008 Sep;159(4):903-6</RefSource><PMID Version="1">18671781</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Ann Trop Med Parasitol. 2008 Sep;102(6):529-40</RefSource><PMID 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Evaluation</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004604" MajorTopicYN="N">Elephantiasis</DescriptorName><QualifierName UI="Q000175" MajorTopicYN="N">diagnosis</QualifierName><QualifierName UI="Q000503" MajorTopicYN="N">physiopathology</QualifierName><QualifierName UI="Q000523" MajorTopicYN="N">psychology</QualifierName><QualifierName UI="Q000628" MajorTopicYN="Y">therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005002" MajorTopicYN="N" Type="Geographic">Ethiopia</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005081" MajorTopicYN="N">Exercise Therapy</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007722" MajorTopicYN="N">Health Knowledge, Attitudes, Practice</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006920" MajorTopicYN="N">Hygiene</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007258" MajorTopicYN="N">Informed Consent</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D058069" MajorTopicYN="N">Neglected Diseases</DescriptorName><QualifierName UI="Q000175" MajorTopicYN="N">diagnosis</QualifierName><QualifierName UI="Q000503" MajorTopicYN="N">physiopathology</QualifierName><QualifierName UI="Q000523" MajorTopicYN="N">psychology</QualifierName><QualifierName UI="Q000628" MajorTopicYN="Y">therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D010349" MajorTopicYN="N">Patient Compliance</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D010353" MajorTopicYN="N">Patient Education as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011287" MajorTopicYN="N">Prejudice</DescriptorName><QualifierName UI="Q000523" MajorTopicYN="N">psychology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011788" MajorTopicYN="N">Quality of Life</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012107" MajorTopicYN="N">Research Design</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012648" MajorTopicYN="Y">Self Care</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D057566" MajorTopicYN="N">Self Report</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012720" MajorTopicYN="N">Severity of Illness Index</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012775" MajorTopicYN="N">Shoes</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013240" MajorTopicYN="N">Stereotyping</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013997" MajorTopicYN="N">Time Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D061665" MajorTopicYN="Y">Time-to-Treatment</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><OtherID 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