UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030221 |
|---|---|
| Receipt number | 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 01:14:44 |
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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
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
unomariko@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Hiroshima University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034508
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
