UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035604
Receipt No. R000040568
Scientific Title Development of the Hiesho improvement support model to promote adherence among pregnant women-development of educational material using digital contents to improve nursing knowledge.
Date of disclosure of the study information 2019/01/21
Last modified on 2019/01/21

* 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 Development of the Hiesho improvement support model to promote adherence among pregnant women-development of educational material using digital contents to improve nursing knowledge.
Acronym Development of the Hiesho improvement support model-development of educational material for nurses.
Scientific Title Development of the Hiesho improvement support model to promote adherence among pregnant women-development of educational material using digital contents to improve nursing knowledge.
Scientific Title:Acronym Development of the Hiesho improvement support model-development of educational material for nurses.
Region
Japan

Condition
Condition Nurses working at the maternity or outpatient ward in the hospital or medical clinic, who consented to participate in the study.
Classification by specialty
Obsterics and gynecology Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Developing educational material for nurses based on evidence, using digital contents about the Hiesho of pregnant women, and evaluating the effectiveness of the material in improving nurses' knowledge of Hiesho and awareness regarding Hiesho care.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes In the intervention group, knowledge of Hiesho of the nurse working at maternity ward is significantly higher compared to the control group (p<0.05) after intervention.
Key secondary outcomes Following intervention, nurses in the intervention group, who worked in the maternity ward, exhibited a significant improvement in their knowledge of Hiesho as compared to those in the control group (p<0.05).

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention period: 2 weeks
Description of intervention:
Intervention group: 1) 1 week studying using digital contents on knowledge of Hiesho (Part 1: Theory) 2) 1 week studying using digital contents on improving Hiesho care (Part 2: Practice)
Interventions/Control_2 Control group: Studying using a brochure (1st week: diagnosis of Hiesho, 2nd week: Program for improving Hiesho care)
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 Female
Key inclusion criteria Nurses working at the maternity or outpatient ward in the hospital or medical clinic, who consented to participate in the study.
Key exclusion criteria Participants who do not meet the inclusion criteria.
Target sample size 124

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sachiyo Nakamura
Organization Yokohama City University
Division name School of Medical Nursing Course
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama, Kanazawa 236-0004, Japan
TEL 045-878-2786
Email nakamura@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sachiyo Nakamura
Organization Yokohama City University
Division name School of Medical Nursing Course
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama, Kanazawa 236-0004, Japan
TEL 045-878-2786
Homepage URL
Email nakamura@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sport, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 01 Month 21 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
2018 Year 08 Month 21 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 01 Month 21 Day
Last modified on
2019 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040568

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.