UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039468 |
|---|---|
| Receipt number | R000044823 |
| Scientific Title | Integrated community led-dog management to enhance the elimination of domestic dog bites and domestic dog-mediated human rabies disease: cluster randomized study |
| Date of disclosure of the study information | 2020/02/12 |
| Last modified on | 2020/08/27 18:19:14 |
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Basic information
Public title
Integrated community led-dog management to enhance the elimination of domestic dog bites and domestic dog-mediated human rabies disease
Acronym
Integrated community led-dog management to enhance the elimination of domestic dog bites and domestic dog-mediated human rabies disease
Scientific Title
Integrated community led-dog management to enhance the elimination of domestic dog bites and domestic dog-mediated human rabies disease: cluster randomized study
Scientific Title:Acronym
Integrated community led-dog management to enhance the elimination of domestic dog bites and domestic dog-mediated human rabies disease: cluster randomized study
Region
| Japan | Africa |
Condition
Condition
Domestic dog bite injury and/or domestic dog mediated human rabies
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Canine rabies is enzootic and, routine control measures, supplies of biologics, relevant recommendations and educational programs are either nonexistent, inoperative or patchy leading to rabies being endemic, wide spread and a neglected disease in Zambia and most other developing countries. There is usually lack of effective educational outreach activities at the community level which has led to gaps in knowledge on best ways to avoid animal bites and administer first aid following animal bites or other forms of exposure. The engagement of community leaders and their communities through the provision of culturally appropriate rabies information, training, and promotion of skill-building activities could improve knowledge of rabies and its prevention. Based on this, an integrated community led-dog management approach will be conducted as a means to increase knowledge and awareness of responsible dog ownership and rabies disease so as to enhance uptake of rabies disease control and prevention activities through dog bite prevention and increased dog vaccination coverage respectively.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Dog vaccination coverage rate
Key secondary outcomes
Knowledge, attitude and practice (KAP) levels of domestic dog-mediated human rabies, its prevention and control.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
3 days Village based participatory knowledge exchange/discussion and training meetings on dog bites and rabies disease and their prevention. This is for the intervention arm
Interventions/Control_2
No intervention activities for the control arm
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study participants target are all permanent residents households heads, adults aged 16 years and above who will agree to join the study.
Key exclusion criteria
Household heads and/or representatives who decline to participate in the study and those who may be visitors in the study area/period and are not permanent residents will be excluded.
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | Gelly |
| Middle name | Simakechula |
| Last name | Chikuni |
Organization
Nagasaki University
Division name
School of tropical Medicine and Global Health
Zip code
852-8523
Address
1-12-4 Sakamoto, Nagasaki
TEL
080-9801-4159
gsimakechula@gmail.com
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kaneko |
Organization
Nagasaki University
Division name
Institute of Tropical Medicine, Nagasaki University
Zip code
852-8523
Address
1-12-4 Sakamoto, Nagasaki
TEL
+81-95-819-7866
Homepage URL
http://www.tm.nagasaki-u.ac.jp/nekken/english/research/eco-epidemiology.html
skaneko@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University, School of Tropical Medicine and Global Health
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University,
School of Tropical Medicine and Global Health
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University, School of Tropical Medicine and Global Health Ethical Committee
Address
852-8523, 1-12-4 Sakamoto, Nagasaki, Japan
Tel
095-819-7583
tmgh_jimu@ml.nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Delayed to start the research due to COVID-19 limitations in travel to the research site and eventual change of research site.
Date of the first journal publication of results
| 2021 | Year | 09 | Month | 30 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 12 | Day |
Last modified on
| 2020 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044823
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
