UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058673 |
|---|---|
| Receipt number | R000067036 |
| Scientific Title | Enhancing malaria knowledge in ethnic minority people in Nong district, Savannakhet province, Lao PDR: a cluster randomized controlled trial |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/08/01 20:22:42 |
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Basic information
Public title
Enhancing malaria knowledge in ethnic minority people in Nong district, Savannakhet province, Lao PDR: a cluster randomized controlled trial
Acronym
Enhancing malaria knowledge in ethnic minority people in Lao PDR
Scientific Title
Enhancing malaria knowledge in ethnic minority people in Nong district, Savannakhet province, Lao PDR: a cluster randomized controlled trial
Scientific Title:Acronym
Enhancing malaria knowledge in ethnic minority people in Lao PDR
Region
| Asia(except Japan) |
Condition
Condition
Malaria
Classification by specialty
| Nursing | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of culturaly tailerd malaria education among ethinic minority people in Nong district, Lao PDR
Basic objectives2
Others
Basic objectives -Others
To assess whether people living in Nong district improve their knowledge about malaria before and after the intervention
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Knowledge about malaria (i.e., knowledge about transmission)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Watching video on malaria control
Interventions/Control_2
Watching video on hand hygiene and food hygiene
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
| 8 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Child participants
1. Child who is the 3rd, 4th or 5th grade student of the study schools
2. Child who is at class on the day of survey
Guardian participants
1. Guardian of the child
2. Aged 18 years old or older
3. Guardian who is at home on the day of survey
Neighbor participants
1. Neighbor living next to the child
2. Aged 18 years old or older
3. Neighbor who is at home on the day of survey
Key exclusion criteria
Child participants
1. Student whom schoolteachers consider inappropriate for participating in the study
Guardian participants and neighbor participants
1. Village resident whom village heads, deputy village heads or other village excecutives consider inappropriate for participating in the study
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Nonaka |
Organization
University of the Ryukyus
Division name
School of Health Sciences, Faculty of Medicine
Zip code
9012725
Address
Kiyuna 1076, Ginowan-city, Okinawa
TEL
+81-98-894-5645
nonakad@cs.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Nouhak |
| Middle name | |
| Last name | Inthavong |
Organization
University of the Ryukyus
Division name
Graduate School of Health Sciences
Zip code
9012725
Address
Kiyuna 1076, Ginowan-city, Okinawa
TEL
+81-98-894-5645
Homepage URL
nouhak_25@yahoo.com
Sponsor or person
Institute
University of the Ryukyus
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japan International Cooperation Agency
IRB Contact (For public release)
Organization
Ethics Review Committee for Medical and Biological Research Involving Human Subjects, University of the Ryukyus
Address
Kiyuna 1076, Ginowan-city, Okinawa
Tel
+81-98-894-1365
krinken@acs.u-ryukyu.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
| 2025 | Year | 08 | Month | 01 | 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
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 01 | Day |
Last modified on
| 2025 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067036
