Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202108907851342 Date of Approval: 17/08/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A family-based intervention for prevention and self-management of disabilities due to leprosy, podoconiosis and lymphatic filariasis versus usual care in Ethiopia: cluster-randomized controlled trial
Official scientific title Effectiveness of family-based intervention for prevention and sustainable self-management of disabilities, impacting the quality of life, mental wellbeing and participation of people with leprosy, podoconiosis and lymphatic filariasis and their families in the East and West Gojjam Zones, Northwest Ethiopia.
Brief summary describing the background and objectives of the trial Background: Persons affected by leprosy, lymphatic filariasis (LF) and podoconiosis often experience restrictions in their daily lives, due to their impairments. Most impairment can be prevented when self-management is practiced. There have been efforts to formulate self-care groups, in which people meet and support each other on a regular basis. However, the involvement of families in preventing disabilities has received little attention. To date most prevention of disability effectiveness studies has been flawed by failing to use a randomized controlled design. This has resulted in a lack of evidence about the effectiveness of these interventions. To collect credible evidence for a new, family-based approach, the current study will use a randomized controlled design. The aim of this study will be to assess the effectiveness of a family-based intervention for prevention and self-management of disabilities due to leprosy, podoconiosis and LF compared to usual practice and care, East and West Gojjam Zones, Ethiopia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Leprosy, Lymphatic filariasis and Podoconiosis
Purpose of the trial Supportive care
Anticipated trial start date 01/10/2021
Actual trial start date
Anticipated date of last follow up 30/09/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 630
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Family based intervention Four sessions 12 months In the planed study, family-based intervention which consists of three basic care components. Thus are: a. self-management of disabilities due to leprosy, lymphatic filariasis/Podoconiosis; b. economic empowerment of peoples affected by the three diseases; and c. psychosocial support to persons affected by the disability and their family members. The disabled persons and one family member will involve in awareness creation about the cause, impact, prevention and control of the diseases and how to manage the disability. In addition, the family members will get empowerment to give sustainable support for the disabled persons. Totally the intervention will have four training sessions. Moreover, persons affected by the diseases will be assisted to create self help associations. Once they established association, they will collect small amount of money from the members monthly and access saving credits. Besides, they will encourage to ask and get their right from the government and non-governmental organizations. Along with the listed intervention psychological support will be given to reduce stigma associated with the disability. 420
Control Group Usual practice 12 months The control group will take treatment as usual care. Disabled persons will take one general session about the diseases cause, how to manage disability, material support that assist the self-management of disability. In this group no family member will be involved in the training and follow-up sessions. 210 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All men and women ≥ 15 years Affected by leprosy-, Lymphatic filariasis- or podoconiosis-related disabilities will be included in this study. All persons have to be residents of project areas of the study. People who are unable to participate in an interview Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/10/2020 Debre Markos University Health Sciences College Institutional Research Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Endimata Eyesus Debre Markos 0269 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Family quality of life Before administration of intervention at baseline and after four session of the intervention.
Secondary Outcome Perceived, experienced and self-stigma Before administration of intervention at baseline and after four session of the intervention.
Secondary Outcome Social participation Before administration of intervention at baseline and after four session of the intervention.
Primary Outcome Mental wellbeing Before administration of intervention at baseline and after four session of the intervention.
Secondary Outcome Economic empowerment Before administration of intervention at baseline and after four session of the intervention.
Primary Outcome Disability management practices Before administration of intervention at baseline and after four session of the intervention.
Secondary Outcome Acceptability At the end of the intervention.
Primary Outcome Physical impairment outcomes Before administration of intervention at baseline and after four session of the intervention.
Secondary Outcome Disease knowledge At the beginning and end of the intervention.
Secondary Outcome Attitudes At the beginning and end of intervention.
Secondary Outcome Most significant change in the community At the end of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dega Damot Feres bet Feres bet Ethiopia
Dembecha Dembecha Dembecha Ethiopia
Enarge Enawga Debre Work Debre Work Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Leprosy Research Initiative Wibautstraat 137k, 1097 DN Amsterdam Amsterdam 95005 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Leprosy Research Initiative Wibautstraat 137k, 1097 DN Amsterdam Amsterdam 95005 Netherlands Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
Ethiopian National Association of Persons Affected by Leprosy Zenebework Addis Ababa 70811 Ethiopia
Disability Studies in Netherlands Stadsring 2 3811 HR Amersfoort Amsterdam Netherlands
Debre Markos University Endimata Eyesus Debre Markos 0269 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Moges Wubie Aycheh mogeswub@gmail.com +251912076152 Bole Kebele 08
City Postal code Country Position/Affiliation
Debre Markos 0269 Ethiopia Debre Markos University
Role Name Email Phone Street address
Public Enquiries Tesfaye Tadesse tadesse.tesfaye@ymail.com +251911440367 Zenebework
City Postal code Country Position/Affiliation
Addis Ababa 70811 Ethiopia Ethiopian National Association of Persons Affected by Leprosy
Role Name Email Phone Street address
Public Enquiries Nurilign Abebe Moges nure113@gmail.com +251910106295 Endimata Eyesus
City Postal code Country Position/Affiliation
Debre Markos 0269 Ethiopia Debre Markos University
Role Name Email Phone Street address
Scientific Enquiries Alice Schippers alice.schippers@disabilitystudies.nl +31619933345 Bikkerspolder 14, 3453 NW,
City Postal code Country Position/Affiliation
De Meern Netherlands Disability Studies in Netherlands
Role Name Email Phone Street address
Scientific Enquiries Anna vant Noordende a.vt.noordende@nlrinternational.org +31205950522 Wibautstraat 137K, 1097 DN, Amsterdam
City Postal code Country Position/Affiliation
Amsterdam Netherlands Netherlands Leprosy Relief and Disability Studies in Netherlands
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share IPD that support the results going to be reported in different articles. The data used to construct in text, tables, figures, and appendices will be provided within one year after publication. In addition, the finding of this intervention will be analyzed and disseminated through journal articles, policy reports, and presentations at national, regional, and international conferences and meetings. Informed Consent Form,Study Protocol The IPD may be shared within 12 months after publication of the research papers. Based on formal request, the principal investigator can share data after discussing with research project team members.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information