UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045200 |
|---|---|
| Receipt number | R000051639 |
| Scientific Title | The clinical survey of self-management of patients with chronic heart failure using the heart failure management application. |
| Date of disclosure of the study information | 2021/08/19 |
| Last modified on | 2024/08/22 10:56:03 |
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Basic information
Public title
The clinical survey of self-management of patients with chronic heart failure using the heart failure management application.
Acronym
The clinical survey of self-management of patients with chronic heart failure using the heart failure management application.
Scientific Title
The clinical survey of self-management of patients with chronic heart failure using the heart failure management application.
Scientific Title:Acronym
The clinical survey of self-management of patients with chronic heart failure using the heart failure management application.
Region
| Japan |
Condition
Condition
Chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the vital data such as daily blood pressure, heart rate and body weight inputted with the heart failure management application affect the self-management, and to verify the usage status of the application.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The usage rate and status of the application
Key secondary outcomes
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who:
(1) was diagnosed with chronic heart failure
(2) have a smartphone that can connect the Internet
(3) gives written informed consent before enrolling the study
Key exclusion criteria
Patients who:
(1) do not have a smartphone or can not connect the Internet
(2) do not use a smartphone or the application due to impaired cognitive or physical function
(3) refuse to download the application and the agreement
(4) is considered ineligible for enrolling the study by a principal investigator or sub-investigator
(5) is unstable heart failure (NYHA 4) and need continuous hospitalization
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Dohi |
Organization
Mie University Graduate School of Medicine
Division name
Cardiology and Nephrology
Zip code
514-8507
Address
Edobashi 2-174, Tsu, Mie, Japan
TEL
059-231-5015
dohik@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromasa |
| Middle name | |
| Last name | Ito |
Organization
Mie University Hospital
Division name
CCU Network Support Center
Zip code
514-8507
Address
Edobashi 2-174, Tsu, Mie, Japan
TEL
059-231-5015
Homepage URL
h-ito@med.mie-u.ac.jp
Sponsor or person
Institute
Mie University Hospital
Institute
Department
Personal name
Funding Source
Organization
Mie University Graduate School of Medicine, Department of Cardiology and Nephrology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Clinical Research Ethics Review Committee of Mie University Hospital
Address
Edobashi 2-174, Tsu, Mie, Japan
Tel
059-231-5246
kk-sien@med.mie-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
| 2021 | Year | 08 | Month | 19 | 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
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 04 | Month | 30 | Day |
Other
Other related information
Nothing
Management information
Registered date
| 2021 | Year | 08 | Month | 19 | Day |
Last modified on
| 2024 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051639
