UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of multidisciplinary approach on QOL in elderly patients with heart failure
Title of the study (Brief title)	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	Hiderori Arai
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Human Health Sciences
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	Hiderori Arai
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Human Health Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 03 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000006293