UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005290 |
|---|---|
| Receipt number | 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 15:44:10 |
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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
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
harai@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006293
