UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033140 |
|---|---|
| Receipt number | 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 | 2022/05/18 05:32:26 |
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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
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
morimich@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
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
unset
Publication of results
Unpublished
Result
URL related to results and publications
unset
Number of participants that the trial has enrolled
74
Results
Three months after discharge, characteristics were compared between the MCI and normal groups on the heart failure self-care scale and quality of life.
The results showed that there was no significant difference in heart failure self-care ability, and patients with MCI were able to maintain the same level as normal patients.
In terms of QOL, the MCI group had significantly lower VAS.
Results date posted
| 2022 | Year | 05 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Comparing the MCI and normal groups at enrollment, the MCI group was significantly older, had higher rates of diabetes comorbidity, fewer years of education, higher HbA1c, and lower quality of life.
There were no significant differences in self-care ability or locus of control, and the results were similar to those of normal individuals even if they had MCI.
Participant flow
Eligibility benchmark n=80
Consent to obtain n=6
Research registrants n=74
MCI group at the time of registration n=44
Normal group at the time of registration n=30
MCI group after 3 months of discharge n=35
Normal group after 3 months of discharge n=23
Adverse events
None
Outcome measures
Three months after discharge, characteristics were compared between the MCI and normal groups on the heart failure self-care scale and quality of life.
The results showed that there was no significant difference in heart failure self-care ability, and patients with MCI were able to maintain the same level as normal patients.
In terms of QOL, the MCI group had significantly lower VAS.
The readmission rate after 3 months of discharge between the MCI and normal groups tended to be higher in the MCI group, but there was no significant difference.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2021 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
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
| 2022 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037212
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