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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001715
Receipt No. 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

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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
Email

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
Email naokat-tky@umin.ac.jp

Sponsor
Institute Department of Adult Nursing, Graduate School of Medicine, The University of Tokyo
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002067

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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