Podoconiosis treatment in northern Ethiopia (GoLBet): study protocol for a randomised controlled trial
Identifieur interne : 001986 ( Main/Exploration ); précédent : 001985; suivant : 001987Podoconiosis treatment in northern Ethiopia (GoLBet): study protocol for a randomised controlled trial
Auteurs : Henok Negussie [Royaume-Uni] ; Meseret Molla Kassahun [Éthiopie] ; Greg Fegan [Royaume-Uni, Kenya] ; Patricia Njuguna [Kenya] ; Fikre Enquselassie [Éthiopie] ; Andy Mckay [Royaume-Uni] ; Melanie Newport [Royaume-Uni] ; Trudie Lang [Royaume-Uni] ; Gail Davey [Royaume-Uni]Source :
- Trials [ 1745-6215 ] ; 2015.
Descripteurs français
- KwdFr :
- Autorapport, Autosoins, Bandages, Chaussures, Connaissances, attitudes et pratiques en santé, Consentement libre et éclairé, Coût de la maladie, Délai jusqu'au traitement, Facteurs temps, Humains, Hygiène, Indice de gravité médicale, Maladie aigüe, Maladies négligées (), Maladies négligées (diagnostic), Maladies négligées (physiopathologie), Maladies négligées (psychologie), Observance thérapeutique, Plan de recherche, Prejugé (psychologie), Protocoles cliniques, Qualité de vie, Résultat thérapeutique, Stéréotypage, Traitement par les exercices physiques, Éducation du patient comme sujet, Éléphantiasis (), Éléphantiasis (diagnostic), Éléphantiasis (physiopathologie), Éléphantiasis (psychologie), Éthiopie, Évaluation de l'incapacité.
- MESH :
- diagnostic : Maladies négligées, Éléphantiasis.
- physiopathologie : Maladies négligées, Éléphantiasis.
- psychologie : Maladies négligées, Prejugé, Éléphantiasis.
- Autorapport, Autosoins, Bandages, Chaussures, Connaissances, attitudes et pratiques en santé, Consentement libre et éclairé, Coût de la maladie, Délai jusqu'au traitement, Facteurs temps, Humains, Hygiène, Indice de gravité médicale, Maladie aigüe, Maladies négligées, Observance thérapeutique, Plan de recherche, Protocoles cliniques, Qualité de vie, Résultat thérapeutique, Stéréotypage, Traitement par les exercices physiques, Éducation du patient comme sujet, Éléphantiasis, Éthiopie, Évaluation de l'incapacité.
- Wicri :
- geographic : Éthiopie.
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.
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.
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.
International Standard Randomised Controlled Trial Number. Registration number:
Url:
DOI: 10.1186/s13063-015-0818-7
PubMed: 26177812
PubMed Central: 4504163
Affiliations:
- Kenya, Royaume-Uni, Éthiopie
- Angleterre, Oxfordshire, Sussex de l'Est
- Brighton, Falmer, Oxford
- Université du Sussex
Links toward previous steps (curation, corpus...)
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Le document en format XML
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<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>
<keywords scheme="MESH" xml:lang="fr"><term>Autorapport</term>
<term>Autosoins</term>
<term>Bandages</term>
<term>Chaussures</term>
<term>Connaissances, attitudes et pratiques en santé</term>
<term>Consentement libre et éclairé</term>
<term>Coût de la maladie</term>
<term>Délai jusqu'au traitement</term>
<term>Facteurs temps</term>
<term>Humains</term>
<term>Hygiène</term>
<term>Indice de gravité médicale</term>
<term>Maladie aigüe</term>
<term>Maladies négligées</term>
<term>Observance thérapeutique</term>
<term>Plan de recherche</term>
<term>Protocoles cliniques</term>
<term>Qualité de vie</term>
<term>Résultat thérapeutique</term>
<term>Stéréotypage</term>
<term>Traitement par les exercices physiques</term>
<term>Éducation du patient comme sujet</term>
<term>Éléphantiasis</term>
<term>Éthiopie</term>
<term>Évaluation de l'incapacité</term>
</keywords>
<keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Éthiopie</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><sec><title>Background</title>
<p>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.</p>
</sec>
<sec><title>Methods/Design</title>
<p>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.</p>
</sec>
<sec><title>Discussion</title>
<p>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.</p>
</sec>
<sec><title>Trial registration</title>
<p>International Standard Randomised Controlled Trial Number. Registration number: <ext-link ext-link-type="uri" xlink:href="http://www.controlled-trials.com/ISRCTN67805210">ISRCTN67805210</ext-link>
. Date of registration: 24 January 2013.</p>
</sec>
</div>
</front>
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<author><name sortKey="Bull, S" uniqKey="Bull S">S Bull</name>
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<biblStruct><analytic><author><name sortKey="Alemu, G" uniqKey="Alemu G">G Alemu</name>
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</div1>
</back>
</TEI>
<affiliations><list><country><li>Kenya</li>
<li>Royaume-Uni</li>
<li>Éthiopie</li>
</country>
<region><li>Angleterre</li>
<li>Oxfordshire</li>
<li>Sussex de l'Est</li>
</region>
<settlement><li>Brighton</li>
<li>Falmer</li>
<li>Oxford</li>
</settlement>
<orgName><li>Université du Sussex</li>
</orgName>
</list>
<tree><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Negussie, Henok" sort="Negussie, Henok" uniqKey="Negussie H" first="Henok" last="Negussie">Henok Negussie</name>
</region>
<name sortKey="Davey, Gail" sort="Davey, Gail" uniqKey="Davey G" first="Gail" last="Davey">Gail Davey</name>
<name sortKey="Fegan, Greg" sort="Fegan, Greg" uniqKey="Fegan G" first="Greg" last="Fegan">Greg Fegan</name>
<name sortKey="Lang, Trudie" sort="Lang, Trudie" uniqKey="Lang T" first="Trudie" last="Lang">Trudie Lang</name>
<name sortKey="Mckay, Andy" sort="Mckay, Andy" uniqKey="Mckay A" first="Andy" last="Mckay">Andy Mckay</name>
<name sortKey="Newport, Melanie" sort="Newport, Melanie" uniqKey="Newport M" first="Melanie" last="Newport">Melanie Newport</name>
</country>
<country name="Éthiopie"><noRegion><name sortKey="Kassahun, Meseret Molla" sort="Kassahun, Meseret Molla" uniqKey="Kassahun M" first="Meseret Molla" last="Kassahun">Meseret Molla Kassahun</name>
</noRegion>
<name sortKey="Enquselassie, Fikre" sort="Enquselassie, Fikre" uniqKey="Enquselassie F" first="Fikre" last="Enquselassie">Fikre Enquselassie</name>
<name sortKey="Kassahun, Meseret Molla" sort="Kassahun, Meseret Molla" uniqKey="Kassahun M" first="Meseret Molla" last="Kassahun">Meseret Molla Kassahun</name>
</country>
<country name="Kenya"><noRegion><name sortKey="Fegan, Greg" sort="Fegan, Greg" uniqKey="Fegan G" first="Greg" last="Fegan">Greg Fegan</name>
</noRegion>
<name sortKey="Njuguna, Patricia" sort="Njuguna, Patricia" uniqKey="Njuguna P" first="Patricia" last="Njuguna">Patricia Njuguna</name>
</country>
</tree>
</affiliations>
</record>
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