UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000565 |
|---|---|
| Receipt number | R000000657 |
| Scientific Title | Evaluate the efficacy of disease management programs for prognosis of patients with heart failure |
| Date of disclosure of the study information | 2006/12/27 |
| Last modified on | 2012/07/10 15:45:35 |
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Basic information
Public title
Evaluate the efficacy of disease management programs for prognosis of patients with heart failure
Acronym
Japanese Heart Failure Outpatients Disease Management and Cardiac Evaluation(J-HOMECARE)
Scientific Title
Evaluate the efficacy of disease management programs for prognosis of patients with heart failure
Scientific Title:Acronym
Japanese Heart Failure Outpatients Disease Management and Cardiac Evaluation(J-HOMECARE)
Region
| Japan |
Condition
Condition
Chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the benefit of disease management program for prognosis, psychological status and quality of life of patients with heart failure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Prognosis(mortality, readmission due to heart failure)
Key secondary outcomes
Psychological status(depression, anxiety)
QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
(Intervention group) Nurse-led patients education, counseling, home visit once per 2 weeks for 2 months, and monthly telephone contact for 4 months
Interventions/Control_2
(Usual care group) follow-up in clinic
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with heart failure
- patients with heart failure discharged from hospital
- patients with obtained informed consent
- patients with cognitive function to participate in this study
Key exclusion criteria
- Telephone contact not available
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Tsutsui |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, 060-8638, Japan
TEL
011-706-6973
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Tsutsui |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, 060-8638, Japan
TEL
011-706-6973
Homepage URL
htsutsui@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Health Sciences Research Grants from the Japanese Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
| 2006 | Year | 12 | Month | 27 | 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
| 2006 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 12 | Month | 27 | Day |
Last modified on
| 2012 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000657
| 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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