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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028631
Receipt No. R000032769
Scientific Title Influence on Dialysis patients by Zikkuri Ease program intervention. Using nursing intervention affecting self image.
Date of disclosure of the study information 2017/08/10
Last modified on 2017/08/10

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Basic information
Public title
Influence on Dialysis patients by Zikkuri Ease program intervention.
Using nursing intervention affecting self image.
Acronym Influence on Dialysis patients by Zikkuri Ease program intervention.
Scientific Title
Influence on Dialysis patients by Zikkuri Ease program intervention.
Using nursing intervention affecting self image.
Scientific Title:Acronym Influence on Dialysis patients by Zikkuri Ease program intervention.
Region
Japan

Condition
Condition Chronic renal failure
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to clarify the influence on patients caused by intervention using "Card - type Zikkuri EASE Program". Card-type Zikkuri EASE program listens to patients and reveals what their patients value and thoughts. It is an intervention that collects the patient's story as one card. Improvement of the image of the patient to herself can be expected.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Qualitative comments of the patients who received the card, classified into inductive and evaluate.
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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 A quasi-experimental study with A4 size card describing the contents told the patient, pass to the patient intervention study.
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
20 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria 10 name in hemodialysis patients, meet the following requirements to qualify.
(1) patients seeing posters call for participation to the study, their participation in the study indicate the patient obtained or agreed upon by them.
(2) patient consent is obtained, and then understand the meaning, purpose, research contents.
(3) patients for over 20 years.
(4) patient consent is obtained to record on the IC Recorder recording or conversation in notes.
Key exclusion criteria (1) patient not verbal conversations.
(2) patients have been diagnosed with dementia, mental illness.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michoyo Oka
Organization Gunma University
Division name Graduate School of Health Sciences
Zip code
Address 3-39-22, Showamachi, Maebashi-shi, Gumma, Japan
TEL 027-220-7111
Email michiyooka@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kouki Itedan
Organization Gunma University
Division name Graduate School of Health Sciences
Zip code
Address 3-39-22, Showamachi, Maebashi-shi, Gumma, Japan
TEL 027-220-8818
Homepage URL
Email kouki_itedan@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization Gunma University, Graduate School of Health Sciences
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Seseragi hospital
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 せせらぎ病院(群馬県)

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 10 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
2017 Year 07 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 10 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
2017 Year 08 Month 10 Day
Last modified on
2017 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032769

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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