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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name