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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005290
Receipt No. R000006293
Scientific Title Effectiveness of multidisciplinary approach on QOL in elderly patients with heart failure
Date of disclosure of the study information 2011/04/01
Last modified on 2018/12/13

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Basic information
Public title Effectiveness of multidisciplinary approach on QOL in elderly patients with heart failure
Acronym Effectiveness of multidisciplinary approch on QOL
Scientific Title Effectiveness of multidisciplinary approach on QOL in elderly patients with heart failure
Scientific Title:Acronym Effectiveness of multidisciplinary approch on QOL
Region
Japan

Condition
Condition heart failure
Classification by specialty
Cardiology Geriatrics Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the multidisciplinary approach on QOL in elderly 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 QOL, ADL
Key secondary outcomes all-cause mortality and length of hospitalization, number of readmission due to heart failure

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 3
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 (Intensive Intervention group) multidisciplinary approach for discharge planning and intervention.
Interventions/Control_2 (Intervention group) observation and education care by home visiting nurses
Interventions/Control_3 (Usual care group) follow-up at clinic
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 heart failure by Framingham Study 1)more than 65 years old 2)discharge from hospital to home
Key exclusion criteria 1)more than level 3 of long-term care insurance 2)terminal stage of cancer
3)planned cardiac surgery
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiderori Arai
Organization Kyoto University Graduate School of Medicine
Division name Department of Human Health Sciences
Zip code
Address 53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL 075-751-3861
Email harai@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiderori Arai
Organization Kyoto University Graduate School of Medicine
Division name Department of Human Health Sciences
Zip code
Address 53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL 075-751-3861
Homepage URL
Email harai@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization Private funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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 京都大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2011 Year 04 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
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
2011 Year 03 Month 22 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
2015 Year 06 Month 01 Day
Date of closure to data entry
2015 Year 12 Month 01 Day
Date trial data considered complete
2016 Year 03 Month 01 Day
Date analysis concluded
2018 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 03 Month 23 Day
Last modified on
2018 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006293

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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