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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024783
Receipt No. R000028512
Scientific Title The Current of Frailty in Patients with Chronic Hemodialysis
Date of disclosure of the study information 2016/11/10
Last modified on 2017/11/14

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Basic information
Public title The Current of Frailty in Patients with Chronic Hemodialysis
Acronym Frailty in Hemodialysis Patients
Scientific Title The Current of Frailty in Patients with Chronic Hemodialysis
Scientific Title:Acronym Frailty in Hemodialysis Patients
Region
Japan

Condition
Condition Frailty
Classification by specialty
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The ESRD population is also aging worldwide, particularly in Japan. Mean age of all Japanese prevalent ESRD populations is 67.2 years and 61.8 percent of patients were 65 years old and above, and 30.3 percent were 75 years old and above at the end of 2013. According to the Fried definition, the frailty status has been documented in 7 percent of elderly population, 14 percent of CKD patients without dialysis and 42 percent of hemodialysis (HD) adult ESRD patients. Japanese elderly populations and CKD patients at frailty status are almost comparable with above-mentioned prevalence. However, the status of frailty in Japanese HD patients remains unknown.
The purpose of this study is to identify the prevalence and predictors of frailty in Japanese HD patients.
Basic objectives2 Others
Basic objectives -Others the comparison of frailty between elderly and non-elderly
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes the prevalence of frailty in patients with hemodialysis
Key secondary outcomes the predictors of frailty

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The subjects were all chronic HD patients who regularly visited the institutions within the period of this study, and who agreed with the aim and protocol of the present study.
Key exclusion criteria The initial exclusion criteria were: refusal to participate, hospitalization due to accidents or sickness, and patients with difficulties to answer the questionnaire. Finally, we excluded participants who did not fill the frailty contents in questionnaire completely, from those remaining after initial exclusion.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruhito A. Uchida
Organization Okayama University
Division name Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code
Address 2-5-1 SHIKATA-CHO KITA-KU, Okayama 700-8558, Japan
TEL 086-235-7235
Email hauchida@okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Haruhito A. Uchida
Organization Okayama University
Division name Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code
Address 2-5-1 SHIKATA-CHO KITA-KU, Okayama 700-8558, Japan
TEL 086-235-7235
Homepage URL
Email hauchida@okayama-u.ac.jp

Sponsor
Institute Department of Medicine, Innnoshima General Hospital, Hiroshima, Japan
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Nippon Kokan Fukuyama Hospital, Sumitomo Besshi Hospital, Mihara Shiromachi Hospital, Akaiwa Ishikai Hospital and Sugimoto Clinic
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 因島総合病院(広島県)、日本鋼管福山病院(広島県)、住友別子病院(愛媛県)、三原城町病院(広島県)、赤磐医師会病院(岡山県)、杉本クリニック(岡山県)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Of the 542 patients visiting each institution, 388 were enrolled in this study.  In total, 26.0 percent of participants were categorized as not-frailty, 52.6 percent as pre-frailty and 21.4 percent as frailty.  The prevalence of frailty increased steadily with age and was more prevalent in females than in males and the subjects with frailty received polypharmacy.  A multivariate logistic regression analysis revealed that the factors independently associated with frailty were the following: female gender (OR 3.661), age (OR 1.065), age above 75 years old (OR 4.892), body mass index (BMI) bellow 18.5 (OR 0.110), number of medications being taken (OR 1.351), diabetes mellitus (DM) (OR 2.765) and MNA-SF bellow 11 (OR 7.405).  Frailty was associated with the accumulation of risk factors.
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
2015 Year 08 Month 17 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 01 Day
Last follow-up date
2016 Year 01 Month 31 Day
Date of closure to data entry
2017 Year 11 Month 13 Day
Date trial data considered complete
2017 Year 11 Month 13 Day
Date analysis concluded
2017 Year 11 Month 13 Day

Other
Other related information This result will be published on the "Aging and Disease" in Februaly 2018.
The detail is placed on bellow URL.
http://www.aginganddisease.org/EN/10.14336/AD.2017.0429

Management information
Registered date
2016 Year 11 Month 10 Day
Last modified on
2017 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028512

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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