UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Disease Management Program with Telemonitoring System in Patients with Chronic Heart Failure to Prevent Readmission :(Pilot Study)
Title of the study (Brief title)	Disease Management Program with Telemonitoring System in Patients with Chronic Heart Failure to Prevent Readmission
Region	Japan

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

Objectives
Narrative objectives1	Examining the most effective patient support method is essential to prevent aggravation and re-hospitalization due to acute exacerbation of patients with chronic heart failure. Specifically, for the patients of chronic heart failure with high severity; (1) self-management education method incorporating a remote monitoring system for self-management education by nurses and (2) self-monitoring for self-management education by nurses.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	self-efficacy(at 6,12,18,24months) QOL(at 6,12,18,24months) self-care behavior(at 6,12,18,24months) readmission due to heart failure readmission due to all cause death depression(at 6,12,18,24months Patient Satisfaction
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Implementation of disease management program (self-management education and behavioral change for 6 months, and writing in self-management notebook for 12 months) and implementation of telenursing using telemonitoring system.
Interventions/Control_2	Implementation of disease management program (self-management education and behavioral change for 6 months, and writing in self-management notebook for 12 months)
Interventions/Control_3	The participants received routine medical consultations.
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	1.being diagnosed with HF classified as New York Heart Association Class II to IV at registration, but III or IV when exacerbated 2.having at least one previous admission for HF or experienced an unplanned hospital visit with exacerbation of HF. 3. living at home(includes a discharging patient). 4. A patient who is physically and cognitively capable participating the program 5. A patient whom can receive a written consent form
Key exclusion criteria	1.severe comorbidity that require a treatment priority 2. inability to stand still to measure body weight 3. A patient who doesn't have a telephone 4. inability to communicate by telephone 5. A patient who has dementia
Target sample size	60

Research contact person
Name of lead principal investigator	Michiko Moriyama
Organization	Hiroshima university Graduate School of Biomedical & Health Sciences
Division name	Division of Nursing Science
Address	Kasumi 1-2-3 Minami-ku, Hiroshima 734-8553 Japan
TEL	082-257-5365
Email	morimich@hiroshima-u.ac.jp

Public contact
Name of contact person	Mariko Mizukawa
Organization	Hiroshima university Graduate School of Biomedical & Health Sciences
Division name	Ph.D program in Nursing Science
Address	Kasumi 1-2-3 Minami-ku, Hiroshima 734-8553 Japan
TEL	082-257-5367
Homepage URL
Email	unomariko@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University Hiroshima University Hospital
Institute
Department

Funding Source
Organization	Hiroshima Prefecture Government
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor	Hiroshima City Asa Citizens Hospital, Hiroshima, Japan Miyoshi Medical Association Hospital, Miyoshi, Japan JA Onomichi General Hospital, Onomichi, Japan Chugoku Rosai Hospital, Kure, Japan
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

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 11 Month 02 Day
Anticipated trial start date	2012 Year 11 Month 02 Day
Last follow-up date	2015 Year 09 Month 30 Day
Date of closure to data entry	2016 Year 09 Month 30 Day
Date trial data considered complete	2016 Year 09 Month 30 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results	The 18th Annual Scientific Meeting of the Japanese Heart Failure Society
Other related information

Management information
Registered date	2017 Year 12 Month 01 Day
Last modified on	2017 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034508