UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033140
Receipt No. R000037212
Scientific Title Investigation of influencing factors of mild cognitive impairment on heart failure disease management
Date of disclosure of the study information 2018/07/01
Last modified on 2020/01/06

* 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 Investigation of influencing factors of mild cognitive impairment on heart failure disease management
Acronym Influence of mild cognitive impairment on heart failure disease management
Scientific Title Investigation of influencing factors of mild cognitive impairment on heart failure disease management
Scientific Title:Acronym Influence of mild cognitive impairment on heart failure disease management
Region
Japan

Condition
Condition Heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate disease management status of heart failure patients with mild cognitive impairment in comparison to those with normal cognitive function in Japan.
Basic objectives2 Others
Basic objectives -Others Observational study
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Relationship between cognitive function and disease management status (self-care behavior and re-hospitalization) of heart failure patients.
Key secondary outcomes 1. Calculation of cognitive impairment prevalence of inpatients with heart failure during the study.(MoCA-J)
2. Comparison of demographic and clinical features, self-care (EHFScBS), QOL(Euro QOL-5D-5L), and locus of control (General locus of control scale) between patients with normal cognitive function and patients with mild cognitive impairment at baseline.
3. Comparison of self-care (EHFScBS), QOL(Euro QOL-5D-5L),unplanned hospital visits, re-hospitalization, and length of hospital stay between patients with normal cognitive function and patients with mild cognitive impairment (baseline to 3 months).
4. Comparison of re-hospitalization rate 3 months after discharge from patients with normal cognitive function and patients with mild cognitive impairment.
5. Relationship between cognitive subscale scores of MoCA-J and self-care scale.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 1. Those who participated in the cardiac rehabilitation at Hiroshima University Hospital for the diagnosis of heart failure.
2. Patients who are judged to be normal cognitive function and mild cognitive impairment by the cognitive function screening test.
3. Patient who agreed to participate in this research.
Key exclusion criteria 1. Patients who are unable to evaluate cognitive functions due to severe neuropsychiatric disorders, stroke, vision disorders, and hearing impairment.
2. Patients with dementia.
3. Patients who are unable to participate in the study.
Target sample size 130

Research contact person
Name of lead principal investigator
1st name Michiko
Middle name
Last name Moriyama
Organization Hiroshima University
Division name Nursing Science
Zip code 734-8553
Address Kasumi 1-2-3 Minami-ku, Hiroshima 734-8553 Japan
TEL +81-82-257-5365
Email morimich@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Michiko
Middle name
Last name Moriyama
Organization Hiroshima University
Division name Nursing Science
Zip code 734-8553
Address Kasumi 1-2-3 Minami-ku, Hiroshima 734-8553 Japan
TEL +81-82-257-5367
Homepage URL
Email morimich@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Hiroshima University Hospital Heart Failure Center
University of the Ryukyus hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hiroshima University
Address Kasumi 1-2-3 Minami-ku, Hiroshima 734-8553 Japan
Tel +81-82-257-5367
Email morimich@hiroshima-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 ・広島大学病院心不全センター(広島県)/
Hiroshima University Hospital Heart Failure Center
・琉球大学医学部付属病院(沖縄県)/University of the Ryukyus hospital

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 01 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 Enrolling by invitation
Date of protocol fixation
2017 Year 11 Month 16 Day
Date of IRB
2017 Year 12 Month 01 Day
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2022 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information 1. Calculation of cognitive impairment prevalence of inpatients with heart failure during the study (MoCA-J).
2. Comparison of demographic and clinical features, self-care (EHFScBS), QOL(Euro QOL-5D-5L), and locus of control (General locus of control scale) between patients with normal cognitive function and patients with mild cognitive impairment at baseline.
3. Comparison of self-care (EHFScBS), QOL(Euro QOL-5D-5L),unplanned hospital visits, re-hospitalization, and length of hospital stay between patients with normal cognitive function and patients with mild cognitive impairment (baseline to 3 months).
4. Comparison of re-hospitalization rate 3 months after discharge from patients with normal cognitive function and patients with mild cognitive impairment.
5. Relationship between cognitive subscale scores of MoCA-J and self-care scale.

Management information
Registered date
2018 Year 06 Month 25 Day
Last modified on
2020 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037212

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.