UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001715 |
|---|---|
| Receipt number | R000002067 |
| Scientific Title | A randomized controlled trial investigating the effectiveness of self-management program for patients with heart failure |
| Date of disclosure of the study information | 2009/02/18 |
| Last modified on | 2011/08/17 09:13:24 |
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Basic information
Public title
A randomized controlled trial investigating the effectiveness of self-management program for patients with heart failure
Acronym
A randomized controlled trial investigating the effectiveness of self-management program for patients with heart failure
Scientific Title
A randomized controlled trial investigating the effectiveness of self-management program for patients with heart failure
Scientific Title:Acronym
A randomized controlled trial investigating the effectiveness of self-management program for patients with heart failure
Region
| Japan |
Condition
Condition
Chronic heart failure
Classification by specialty
| Cardiology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of heart failure self-management program on self-management behavior, quality of life, morbidity and mortality in patients with heart failure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Self-management behavior
Key secondary outcomes
Quality of Life
Hospitalization for heart failure
All-cause death
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A multi-disciplinary team consisting of a physician, nurse, pharmacist, and dietitian provides self-management program 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients meeting all of the following requirements at the time of registration
1) Diagnosed with heart failure
2) NYHA functional class II or higher
3) Aged 20 years or older
4) Inpatient
Key exclusion criteria
Patients having any of the following criteria at the time of registration
1) Co-morbidities with poor prognosis
2) Severe cognitive disorder
3) Severe psychiatric disease
4) Left ventricular assist device
5) Not providing consent
6) Judged not to be suitable for entry by the attending physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiko Kazuma |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Adult Nursing
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoko Kato |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Adult Nursing
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3508
Homepage URL
naokat-tky@umin.ac.jp
Sponsor or person
Institute
Department of Adult Nursing, Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
The University of Tokyo Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2009 | Year | 02 | Month | 18 | 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
| 2008 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 02 | Month | 17 | Day |
Last modified on
| 2011 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002067
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
