UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034918 |
|---|---|
| Receipt number | R000039797 |
| Scientific Title | The effect of patient education intervention in hospitalized patient with heart failure |
| Date of disclosure of the study information | 2019/05/01 |
| Last modified on | 2020/05/20 09:34:58 |
* 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
The effect of patient education intervention in hospitalized patient with heart failure
Acronym
The effect of patient education intervention in hospitalized patient with heart failure
Scientific Title
The effect of patient education intervention in hospitalized patient with heart failure
Scientific Title:Acronym
The effect of patient education intervention in hospitalized patient with heart failure
Region
| Japan |
Condition
Condition
Heart failure(HF)
Classification by specialty
| Cardiology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the effectiveness of multidisciplinary patient education for patients hospitalized with heart failure preserved ejection fraction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of HF-related hospital readmission
Key secondary outcomes
The Japanese Heart Failure Knowledge Scale
The European heart failure self-care behavior scale
Proportion of daily dairy use
Health related QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Multidisciplinary patient education by using the teach-back method during the hospital stay
Interventions/Control_2
Usual care
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)patient hospitalized with heart failure
2)patient with heart failure preserved ejection fraction
Key exclusion criteria
1) Poor prognosis due to severe comorbidity
2) Be expected to discharge to non-home
3) Do not speak or read Japanese
4) Severe cognitive impairment and severe psychiatric condition
5) Patients who have participated in other studies
Target sample size
190
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Kohzuki |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Internal medicine and rehabilitation science
Zip code
980-8574
Address
1-1, Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7351
kohzuki@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Togashi |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Internal medicine and rehabilitation science
Zip code
980-8574
Address
1-1, Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7353
Homepage URL
shintaro.togashi42@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Not receive funds
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sendai Kosei Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Independent Ethics Committee, Tohoku University Graduate School of Medicine
Address
1-1, Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan
Tel
022-728-4105
med-kenkyo@grp.tohoku.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
一般財団法人厚生会 仙台厚生病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | 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
20
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
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 17 | Day |
Last modified on
| 2020 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039797
