UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Health and Social Impact of Portable Health Clinic Services in Rajasthan, India
Title of the study (Brief title)	Health and Social Impact of Portable Health Clinic Services in Rajasthan, India
Region	Asia(except Japan)

Condition
Condition	Life style diseases
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effectiveness and acceptance of Portable Health Clinic Services
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes of awareness, treatment, and control and complications rates in type 2 diabetes
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	health check up
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	18 years-old <=
Age-upper limit	100 years-old >=
Gender	Male
Key inclusion criteria	(1) Age => 18 (2) Indian nationals (3) Those who signed in the consent form (4) Healthy enough to participate in health check-up
Key exclusion criteria	Those who do not meet the inclusion criteria.
Target sample size	400

Research contact person
Name of lead principal investigator	Fumihiko Yokota
Organization	Kyushu University
Division name	Institute of Decision Science for a Sustainable Society
Address	744 Motooka Nishi Fukuoka
TEL	092-802-6052
Email	yokota.fumihiko.785@m.kyushu-u.ac.jp

Public contact
Name of contact person	Kumi Kido
Organization	Kyushu University
Division name	Institute of Decision Science for a Sustainable Society
Address	744 Motooka Nishi Fukuoka
TEL	092-802-6049
Homepage URL
Email	ketsudan@jimu.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University
Institute
Department

Funding Source
Organization	JST
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2019 Year 05 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 01 Month 18 Day
Anticipated trial start date	2019 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2019 Year 03 Month 05 Day
Last modified on	2019 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041119