UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045729 |
|---|---|
| Receipt number | R000052205 |
| Scientific Title | The effectiveness of a self-management support program starting in the subacute phase based on the symptom experience during acute exacerbation of patients with chronic heart failure |
| Date of disclosure of the study information | 2021/10/15 |
| Last modified on | 2024/10/17 16:36:55 |
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Basic information
Public title
The effectiveness of a self-management support program starting in the subacute phase based on the symptom experience during acute exacerbation of patients with chronic heart failure
Acronym
The effectiveness of a self-management support program starting in the subacute phase based on the symptom experience during acute exacerbation of patients with chronic heart failure
Scientific Title
The effectiveness of a self-management support program starting in the subacute phase based on the symptom experience during acute exacerbation of patients with chronic heart failure
Scientific Title:Acronym
The effectiveness of a self-management support program starting in the subacute phase based on the symptom experience during acute exacerbation of patients with chronic heart failure
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of a self-management support program starting from the subacute stage based on the symptom experience during acute exacerbation of patients with chronic heart failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After the implementation of this program ; before discharge, one month after discharge, and half a year after discharge, the following items will be evaluated.
European Heart Failure Self-care Behavior Scale Japanese ver.
Key secondary outcomes
After the implementation of this program ; before discharge, one month after discharge, and half a year after discharge, the following items will be evaluated.
European Heart Failure Self-care Behavior Scale Japanese ver.
Japanese Heart Failure Knowledge scale
Evaluation Scale for Self-Monitoring by patients with Heart Failure
Semi-structured interviews on heart failure self-care and self-monitoring
Evaluate the presence or absence of the following items 1 year and 2 years after discharge.
Re-hospitalization
Heart accident death
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
| Behavior,custom |
Interventions/Control_1
The following interventions are performed during hospitalization for acute exacerbation of heart failure.
Nurses ask patients about their pre-hospital symptom experiences with questionnaires and tablet devices.
Nurses teach heart failure patients how to manage symptoms with individual pamphlets.
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
Patients admitted to the hospital with a diagnosis of acute exacerbation of chronic heart failure
20 years and over
Patients with written consent
Key exclusion criteria
Patients who have difficulty answering the Japanese questionnaire
Patients whose medical staff deems inappropriate for their participation in research
Patients who refused to participate in the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Shogaki |
Organization
Kobe University Graduate School of Hearth Sciences
Division name
Department of Nursing
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma-ku, Kobe-shi, Hyogo
TEL
078-792-2555
shogaki@people.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Shogaki |
Organization
Kobe University Graduate School of Hearth Sciences
Division name
Department of Nursing
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma-ku, Kobe-shi, Hyogo
TEL
078-792-2555
Homepage URL
shogaki@people.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Hearth Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Graduate School of Hearth Sciences
Address
7-10-2 Tomogaoka, Suma-ku, Kobe-shi, Hyogo
Tel
078-792-4502
syomu2@ams.kobe-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 | 10 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2026 | 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
| 2021 | Year | 10 | Month | 12 | Day |
Last modified on
| 2024 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052205
