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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035932
Receipt No. R000040926
Scientific Title Alliance for Quality Assessment in Healthcare-Dialysis
Date of disclosure of the study information 2019/02/25
Last modified on 2021/03/22

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Basic information
Public title Alliance for Quality Assessment in Healthcare-Dialysis
Acronym Alliance for Quality Assessment in Healthcare-Dialysis (AQuAH-D)
Scientific Title Alliance for Quality Assessment in Healthcare-Dialysis
Scientific Title:Acronym Alliance for Quality Assessment in Healthcare-Dialysis (AQuAH-D)
Region
Japan

Condition
Condition Patients with chronic kidney disease who receive maintenance hemodialysis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To descript variations in pattern of patient care.
To explore characteristics of institution and patients that associate with the patterns of patient care.
To explore associations between the patterns of patient care and patient outcomes.
Basic objectives2 Others
Basic objectives -Others To attain the study objectives, medical records and related information of the study subjects will continuously be collected and will be stored in a research database
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Patterns of patient care
Patient outcomes (deaths, hospitalizations, QOLs)
Key secondary outcomes

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 Outpatients who receive hemodialysis in a dialysis facility.
Patients who gave an informed cancent.
Key exclusion criteria Patients who reveive peritoneal dialysis.
Patients less than 20-year old.
Target sample size 14000

Research contact person
Name of lead principal investigator
1st name Sayaka
Middle name
Last name Shimizu
Organization Institute for Health Outcomes & Process Evaluation Research (iHope International)
Division name Research Department
Zip code 604-8006
Address Shimomaruya-cho 403, Nakagyo-ku, Kyoto, JAPAN
TEL 075-555-3457
Email shimizu@i-hope.jp

Public contact
Name of contact person
1st name Sayaka
Middle name
Last name Shimizu
Organization Institute for Health Outcomes & Process Evaluation Research (iHope International)
Division name Research Department
Zip code 604-8006
Address Shimomaruya-cho 403, Nakagyo-ku, Kyoto, JAPAN
TEL 075-555-3457
Homepage URL https://www.aquah-d.com/
Email aqd@i-hope.jp

Sponsor
Institute Institute for Health Outcomes & Process Evaluation Research (iHope International)
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Ethical Review Committee of iHope International
Address Shimomaruya-cho 403, Nakagyo-ku, Kyoto, JAPAN
Tel 075-555-3457
Email research@i-hope.jp

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 千船クリニック(大阪府)、柏友千代田クリニック(大阪府)、医療法人社団 明洋会柴垣医院自由が丘(東京都)、医療法人社団 明洋会柴垣医院久が原(東京都)、医療法人社団 明洋会柴垣医院戸越(東京都)、西崎内科医院(岡山県)、加美川クリニック(広島県)、飯塚病院(福岡県)、鷹揚郷弘前病院(青森県)、津山中央記念病院(岡山県)、松山医院大分腎臓内科(大分県)、藤井寺敬任会クリニック(大阪府)、良町ふくしまクリニック(熊本県)、仁誠会クリニック光の森(熊本県)、仁誠会クリニックながみね(熊本県)、うきクリニック(熊本県)、春水会山鹿中央病院(熊本県)、松下会あけぼのクリニック(熊本県)、松下会あけぼの第2クリニック(熊本県)、金山クリニック(愛知県)、キナシ大林病院(香川県)、海部医院(香川県)、嶋田病院(熊本県)、仁誠会クリニック新屋敷(熊本県)、仁誠会クリニック黒髪(熊本県)、仁誠会クリニック大津(熊本県)、熊本泌尿器科病院(熊本県)、仁楡会 仁楡会病院(北海道)、仁楡会 澄腎クリニック(北海道)、萌生舎 宮の沢腎・泌尿器科クリニック(北海道)、萌生舎 琴似腎臓内科・泌尿器科(北海道)、朋裕会 とよた腎泌尿器科クリニック(北海道)

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 25 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 Enrolling by invitation
Date of protocol fixation
2018 Year 03 Month 26 Day
Date of IRB
2018 Year 03 Month 26 Day
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
2026 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: open, cohort study.
Subjects: outpatients who receive hemodialysis in participating dialysis facilities.
Study period: from January 2017 to December 2026 (data prior to the initiation of study will be collected retrospectively)
Data collection: health insurance claims, laboratory tests, hemodialysis records, patient characteristics, clinical outcomes, and patient-reported outcomes

Management information
Registered date
2019 Year 02 Month 19 Day
Last modified on
2021 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040926

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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