UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033852 |
|---|---|
| Receipt number | R000035789 |
| Scientific Title | The effect of creating personal history books for patients with chronic heart failure and chronic kidney disease. |
| Date of disclosure of the study information | 2018/08/22 |
| Last modified on | 2023/08/28 13:52:35 |
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Basic information
Public title
The effect of creating personal history books for patients with chronic heart failure and chronic kidney disease.
Acronym
The effect of creating personal history books for patients with chronic heart failure and chronic kidney disease.
Scientific Title
The effect of creating personal history books for patients with chronic heart failure and chronic kidney disease.
Scientific Title:Acronym
The effect of creating personal history books for patients with chronic heart failure and chronic kidney disease.
Region
| Japan |
Condition
Condition
Chronic heart failure and chronic kidney disease
Classification by specialty
| Cardiology | Nephrology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main purpose of this study is to evaluate effects of creating personal history books for patients with chronic heart failure and chronic kidney disease.
Basic objectives2
Others
Basic objectives -Others
The other purpose of this study is to explore possibility to give worth living and hope of patients with chronic heart failure and chronic kidney disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The creating personal history books will improve the spirituality of patients with chronic heart failure and chronic kidney disease.
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention is creating personal history books for chronic heart failure and chronic kidney disease.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
chronic heart failure:
Patient who needs self-management , which has been one year since the onset of heart failure for the first time.
chronic kidney disease:
Patient with chronic kidney stage G3a or later and diabetic nephropathy and do not hemodialysis.
Key exclusion criteria
Patients undergoing diagnosis of dementia.
Patients who are undergoing diagnosis of psychiatric disease.
Patients falling under NewYork Heart Association functional classification 3 and 4.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Michiyo |
| Middle name | |
| Last name | Oka |
Organization
Gunma University , Graduate School of Health Sciences
Division name
Nursing
Zip code
371-8514
Address
3-39-22 , Syouwa-machi , Maebashi , Gunma.
TEL
027-220-8926
michiyooka@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Matsumoto |
Organization
Gunma University , Graduate School of Health Sciences
Division name
Nursing
Zip code
371-8514
Address
3-39-22 , Syouwa-machi , Maebashi , Gunma.
TEL
027-220-8818
Homepage URL
mitsuhiro.m@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University , Graduate School of Health Sciences
Address
3-39-22 , Syouwa-machi , Maebashi , Gunma.
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-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 | 22 | 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 | 04 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2028 | 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 | 21 | Day |
Last modified on
| 2023 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035789
| Research Plan | |
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| 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 |
