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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033852
Receipt No. 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 2020/02/20

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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
Email michiyooka@gunma-u.ac.jp

Public contact
Name of contact person
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
Homepage URL
Email michiyooka@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

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
Email 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
2023 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
2020 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035789

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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