UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028631 |
|---|---|
| Receipt number | 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 18:41:15 |
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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
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
kouki_itedan@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032769
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
