UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025326
Receipt No. R000029132
Scientific Title Dialysis patients take prescribed medications more regularly than their healthcare providers assume
Date of disclosure of the study information 2016/12/20
Last modified on 2016/12/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Dialysis patients take prescribed medications more regularly than their healthcare providers assume
Acronym The gap in the medication compliance between the actual compliance rate and the assumption of healthcare providers
Scientific Title Dialysis patients take prescribed medications more regularly than their healthcare providers assume
Scientific Title:Acronym The gap in the medication compliance between the actual compliance rate and the assumption of healthcare providers
Region
Japan

Condition
Condition Chronic Renal Failure
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We herein investigated both the actual medication compliance rate and the assumed rate by healthcare providers, and analyzed the reasons for their assumption. We also researched whether the age of patients, the number of prescription, the form of medication or the time of dialysis session could affect the medication compliance.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1) The actual medication compliance rate of patients
2) The estimated medication compliance rate by healthcare providers
Key secondary outcomes The medication compliance rate by the age of patients, the number of prescription, the form of medication and the time of dialysis session

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 Among 302 patients on maintenance hemodialysis, 172 patients with self-control were enrolled in this study.
Key exclusion criteria 1) The patients with dementia
2)The patients who had diagnosed psychological disorders
Target sample size 172

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Funakoshi
Organization Nagasaki Kidney Hospital
Division name Department of nephrology
Zip code
Address 5-1 Kouzen-machi, Nagasaki,
TEL 095-824-1101
Email Satoshi2754@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Funakoshi
Organization Nagasaki Kidney Hospital
Division name Department of nephrology
Zip code
Address 5-1 Kouzen-machi, Nagasaki,
TEL 095-824-1101
Homepage URL
Email Satoshi2754@yahoo.co.jp

Sponsor
Institute Nagasaki Kidney Hospital
Department of nephrology
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
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

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 20 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 Completed
Date of protocol fixation
2014 Year 12 Month 06 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Unregistered Investigation

Management information
Registered date
2016 Year 12 Month 19 Day
Last modified on
2016 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029132

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.