UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035932 |
|---|---|
| Receipt number | R000040926 |
| Scientific Title | Alliance for Quality Assessment in Healthcare-Dialysis |
| Date of disclosure of the study information | 2019/02/25 |
| Last modified on | 2023/09/14 15:11:20 |
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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
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/
aqd@pedal.or.jp
Sponsor or person
Institute
Institute for Health Outcomes & Process Evaluation Research (iHope International)
Institute
Department
Personal name
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
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）、光寿会 光寿会クリニック（兵庫）、眞仁会 横須賀クリニック（神奈川）、朋進会 東神クリニック（神奈川）
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
https://bmjopen.bmj.com/content/12/1/e054427
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
| 2023 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.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 |
