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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030221
Receipt No. R000034508
Scientific Title Disease Management Program with Telemonitoring System in Patients with Chronic Heart Failure to Prevent Readmission :(Pilot Study)
Date of disclosure of the study information 2017/12/03
Last modified on 2017/12/21

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Basic information
Public title Disease Management Program with Telemonitoring System in Patients with Chronic Heart Failure to Prevent Readmission :(Pilot Study)

Acronym Disease Management Program with Telemonitoring System in Patients with Chronic Heart Failure to Prevent Readmission
Scientific Title Disease Management Program with Telemonitoring System in Patients with Chronic Heart Failure to Prevent Readmission :(Pilot Study)

Scientific Title:Acronym 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
1st name
Middle name
Last name Michiko Moriyama
Organization Hiroshima university Graduate School of Biomedical & Health Sciences
Division name Division of Nursing Science
Zip code
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
1st name
Middle name
Last name Mariko Mizukawa
Organization Hiroshima university Graduate School of Biomedical & Health Sciences
Division name Ph.D program in Nursing Science
Zip code
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)

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
2017 Year 12 Month 03 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The 18th Annual Scientific Meeting of the Japanese Heart Failure Society
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
2012 Year 11 Month 02 Day
Date of IRB
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

Other
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

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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