Family-based intervention for prevention and self-management of disabilities due to leprosy, podoconiosis and lymphatic filariasis versus usual care in Ethiopia: study protocol for a cluster-randomised controlled trial
Introduction Leprosy, podoconiosis and lymphatic filariasis (LF) are three skin-related neglected tropical diseases. All three conditions can lead to temporary and permanent impairments. These impairments progressively worsen and are major determinants of stigma, discrimination and participation res...
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BMJ Publishing Group
2022-03-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/3/e056620.full |
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| author | Anna Tiny van 't Noordende Moges Wubie Aycheh Nurilign Abebe Moges Tesfaye Tadesse Alice P. Schippers |
| author_facet | Anna Tiny van 't Noordende Moges Wubie Aycheh Nurilign Abebe Moges Tesfaye Tadesse Alice P. Schippers |
| author_sort | Anna Tiny van 't Noordende |
| collection | DOAJ |
| description | Introduction Leprosy, podoconiosis and lymphatic filariasis (LF) are three skin-related neglected tropical diseases. All three conditions can lead to temporary and permanent impairments. These impairments progressively worsen and are major determinants of stigma, discrimination and participation restrictions. Self-care is essential to prevent disabilities and chronic disease complications. Many persons with leprosy-related, LF-related and podoconiosis-related disabilities need to practice self-management routines their entire life. This is difficult without support and encouragement of others. The objective of this study was to assess the effectiveness of a family-based intervention in terms of physical outcomes related to prevention and self-management of disabilities due to leprosy, podoconiosis and LF and family quality of life and well-being compared with usual practice and care.Methods and analysis The study will use a cluster-randomised controlled trial design with two study arms. The project will be carried out in endemic districts in East and West Gojjam zones in the Amhara region in Ethiopia. Clusters consist of kebeles (lower administrative structures in the district) that have been merged, based on their geographical proximity and the number of cases in each kebele. A total of 630 participants will be included in the study. The intervention group will consist of 105 persons affected by leprosy, 105 persons affected by LF or podoconiosis, and 210 family members. The control group will consist of 105 persons affected by leprosy and 105 persons affected by LF or podoconiosis. The family-based intervention comprises an essential care package that consists of the following three main components: (1) self-management of disabilities, (2) economic empowerment and (3) psychosocial support. Participants in the control areas will receive usual practice and care. Data analysis includes, but is not limited to, calculating the percentage of change and corresponding 95% CI of physical impairment outcomes in each group, before and after the intervention is implemented, effect sizes, intention to treat and difference in difference analysis.Ethics and dissemination Ethical approval has been obtained from the Debre Markos University Health Sciences Institutional Research Ethics Review Committee. Results will be disseminated through peer-reviewed publications, conference presentations and workshops.Trial registration number PACTR202108907851342. |
| format | Article |
| id | doaj-art-ceac30773f754ac8a080734237049528 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-03-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-ceac30773f754ac8a0807342370495282025-08-20T01:48:11ZengBMJ Publishing GroupBMJ Open2044-60552022-03-0112310.1136/bmjopen-2021-056620Family-based intervention for prevention and self-management of disabilities due to leprosy, podoconiosis and lymphatic filariasis versus usual care in Ethiopia: study protocol for a cluster-randomised controlled trialAnna Tiny van 't Noordende0Moges Wubie Aycheh1Nurilign Abebe Moges2Tesfaye Tadesse3Alice P. Schippers4Disability Studies in the Netherlands, Utrecht, The NetherlandsPublic Health, College of Health Sciences, Debre Markos University, Debre Markos, EthiopiaPublic Health, College of Health Sciences, Debre Markos University, Debre Markos, EthiopiaProgramme, Ethiopian National Association of Persons Affected by Leprosy (ENAPAL), Addis Ababa, EthiopiaDisability Studies in the Netherlands, Utrecht, The NetherlandsIntroduction Leprosy, podoconiosis and lymphatic filariasis (LF) are three skin-related neglected tropical diseases. All three conditions can lead to temporary and permanent impairments. These impairments progressively worsen and are major determinants of stigma, discrimination and participation restrictions. Self-care is essential to prevent disabilities and chronic disease complications. Many persons with leprosy-related, LF-related and podoconiosis-related disabilities need to practice self-management routines their entire life. This is difficult without support and encouragement of others. The objective of this study was to assess the effectiveness of a family-based intervention in terms of physical outcomes related to prevention and self-management of disabilities due to leprosy, podoconiosis and LF and family quality of life and well-being compared with usual practice and care.Methods and analysis The study will use a cluster-randomised controlled trial design with two study arms. The project will be carried out in endemic districts in East and West Gojjam zones in the Amhara region in Ethiopia. Clusters consist of kebeles (lower administrative structures in the district) that have been merged, based on their geographical proximity and the number of cases in each kebele. A total of 630 participants will be included in the study. The intervention group will consist of 105 persons affected by leprosy, 105 persons affected by LF or podoconiosis, and 210 family members. The control group will consist of 105 persons affected by leprosy and 105 persons affected by LF or podoconiosis. The family-based intervention comprises an essential care package that consists of the following three main components: (1) self-management of disabilities, (2) economic empowerment and (3) psychosocial support. Participants in the control areas will receive usual practice and care. Data analysis includes, but is not limited to, calculating the percentage of change and corresponding 95% CI of physical impairment outcomes in each group, before and after the intervention is implemented, effect sizes, intention to treat and difference in difference analysis.Ethics and dissemination Ethical approval has been obtained from the Debre Markos University Health Sciences Institutional Research Ethics Review Committee. Results will be disseminated through peer-reviewed publications, conference presentations and workshops.Trial registration number PACTR202108907851342.https://bmjopen.bmj.com/content/12/3/e056620.full |
| spellingShingle | Anna Tiny van 't Noordende Moges Wubie Aycheh Nurilign Abebe Moges Tesfaye Tadesse Alice P. Schippers Family-based intervention for prevention and self-management of disabilities due to leprosy, podoconiosis and lymphatic filariasis versus usual care in Ethiopia: study protocol for a cluster-randomised controlled trial BMJ Open |
| title | Family-based intervention for prevention and self-management of disabilities due to leprosy, podoconiosis and lymphatic filariasis versus usual care in Ethiopia: study protocol for a cluster-randomised controlled trial |
| title_full | Family-based intervention for prevention and self-management of disabilities due to leprosy, podoconiosis and lymphatic filariasis versus usual care in Ethiopia: study protocol for a cluster-randomised controlled trial |
| title_fullStr | Family-based intervention for prevention and self-management of disabilities due to leprosy, podoconiosis and lymphatic filariasis versus usual care in Ethiopia: study protocol for a cluster-randomised controlled trial |
| title_full_unstemmed | Family-based intervention for prevention and self-management of disabilities due to leprosy, podoconiosis and lymphatic filariasis versus usual care in Ethiopia: study protocol for a cluster-randomised controlled trial |
| title_short | Family-based intervention for prevention and self-management of disabilities due to leprosy, podoconiosis and lymphatic filariasis versus usual care in Ethiopia: study protocol for a cluster-randomised controlled trial |
| title_sort | family based intervention for prevention and self management of disabilities due to leprosy podoconiosis and lymphatic filariasis versus usual care in ethiopia study protocol for a cluster randomised controlled trial |
| url | https://bmjopen.bmj.com/content/12/3/e056620.full |
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