UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012653 |
|---|---|
| Receipt number | R000014795 |
| Scientific Title | Clinical survey of stroke patients and Long-Term Care Insurance System: a multicenter retrospective cohort study |
| Date of disclosure of the study information | 2013/12/24 |
| Last modified on | 2014/09/29 09:44:13 |
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Basic information
Public title
Clinical survey of stroke patients and Long-Term Care Insurance System: a multicenter retrospective cohort study
Acronym
Clinical survey of stroke patients and LTCI system
Scientific Title
Clinical survey of stroke patients and Long-Term Care Insurance System: a multicenter retrospective cohort study
Scientific Title:Acronym
Clinical survey of stroke patients and LTCI system
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Medicine in general | Geriatrics | Neurosurgery |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To survey patients with stroke
Basic objectives2
Others
Basic objectives -Others
To clarify whether FIM score recorded on admission could predict mRS score, LTCI care level at discharge, and discharge destination.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
functional outcome and discharge destination
Key secondary outcomes
complications, hospital days, and risk factors
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
post-acute stroke patients
Key exclusion criteria
patients who were not eligible for this survey
Target sample size
492
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Saji |
Organization
Kawasaki Medical School (Hyogo Brain and Heart Center at Himeji)
Division name
Department of Stroke Medicine (Department of Neurology)
Zip code
Address
577 Matsushima, Kurashiki, Okayama
TEL
086-462-1111
sajink@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Saji |
Organization
Kawasaki Medical School (Hyogo Brain and Heart Center at Himeji)
Division name
Department of Stroke Medicine (Department of Neurology)
Zip code
Address
577 Matsushima, Kurashiki, Okayama
TEL
086-462-1111
Homepage URL
sajink@nifty.com
Sponsor or person
Institute
Kawasaki Medical School (Hyogo Brain and Heart Center at Himeji)
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
List of participating acute stroke centers and convalescent rehabilitation wards:
Acute stroke centers: Himeji Red Cross Hospital, National Hospital Organization Himeji Medical Center, Steel Memorial Hirohata Hospital, Hyogo Brain and Heart Center at Himeji, Himeji Central Hospital, Tsukazaki Hospital, Irie Hospital, Chokyu Hospital, and Ako City Hospital.
Convalescent rehabilitation wards: Hyogo Prefectural Rehabilitation Hospital at Nishiharima, Ishikawa Hospital, Tsukazaki Memorial Hospital, Hirohata Century Hospital, Irie Hospital, Hakka Hospital, Himeji Tanaka Hospital, Jonan-Tago Hospi
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
川崎医科大学（岡山県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://informahealthcare.com/doi/abs/10.3109/09638288.2014.918195
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
| 2008 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
| 2013 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 10 | Month | 01 | Day |
Other
Other related information
Of 1261 patients (47% female, mean age 75 years), 492 (39%) fulfilled LTCI care levels 0-2. FIM scores were significantly correlated with mRS scores and LTCI care levels at discharge (P <0.001). On multivariate analysis, age and FIM scores on admission were found to be independent predictors of LTCI care levels 0-2, mRS scores 0-2, and home discharge.
Management information
Registered date
| 2013 | Year | 12 | Month | 22 | Day |
Last modified on
| 2014 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014795
