UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033754 |
|---|---|
| Receipt number | R000038504 |
| Scientific Title | A longitudinal study to reduce NCD related risk factors by using Portable Health Clinic system in rural and urban areas in Bangladesh |
| Date of disclosure of the study information | 2018/08/15 |
| Last modified on | 2024/02/02 03:35:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A longitudinal study to reduce NCD related risk factors by using Portable Health Clinic system in rural and urban areas in Bangladesh
Acronym
A longitudinal study to reduce NCD related risk factors by using Portable Health Clinic system in rural and urban areas in Bangladesh
Scientific Title
A longitudinal study to reduce NCD related risk factors by using Portable Health Clinic system in rural and urban areas in Bangladesh
Scientific Title:Acronym
A longitudinal study to reduce NCD related risk factors by using Portable Health Clinic system in rural and urban areas in Bangladesh
Region
| Japan | Asia(except Japan) |
Condition
Condition
Lifestyle-related diseases, Maternal and child health
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Obstetrics and Gynecology | Pediatrics | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment the needs and effects of non-communicable diseases by Portable Health Clinic system
Basic objectives2
Others
Basic objectives -Others
Assessment the needs and effects of mother-child health by Portable Health Clinic system
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the change of prevalence of diabetes by blood-sugar monitoring
Key secondary outcomes
Change in prevalence of hypertension, change in obesity, change in positive proteinuria rate, change in lifestyle behavior
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine | Food | Behavior,custom |
Interventions/Control_1
Health check and remote medical care by Portable Health Clinic system
Interventions/Control_2
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
| 15 | years-old | <= |
Age-upper limit
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Both sexes adults of residents in Bangladesh, are 35 years old and over.
For mother-child health, women are age from 15 to 49 years old.
Every participant has nationality of Bangladesh, has signed in written informed consent, has health status to receive health check and questionnaire.
Key exclusion criteria
Subjects who don't meet any of key inclusion criteria
Target sample size
750
Research contact person
Name of lead principal investigator
| 1st name | Mariko |
| Middle name | |
| Last name | Nishikitani |
Organization
Kyushu University
Division name
Institute of Decision Science for a Sustainable Society
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka-City
TEL
0926426475
nishikitani.mariko.105@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Sultana |
| Middle name | |
| Last name | Nazneen |
Organization
Grameen Communications
Division name
Global Communication Center
Zip code
150820
Address
Grameen Bank Bhaban, 9th Floor, Mirpur-2, Dhaka-1216
TEL
+880(2)8021051
Homepage URL
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000038504
gc@grameen.com
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Toyota motor corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
JST Future Earth
IRB Contact (For public release)
Organization
Kyushu University Hospital IRB
Address
3-1-1-WW6 Maidashi, Higashi-ku, Fukuoka
Tel
092-642-5082
byskenkyu@jimu.kyushu-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
| 2018 | Year | 08 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 15 | Day |
Last modified on
| 2024 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038504
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
