UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dialysis patients take prescribed medications more regularly than their healthcare providers assume
Title of the study (Brief title)	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	Satoshi Funakoshi
Organization	Nagasaki Kidney Hospital
Division name	Department of nephrology
Address	5-1 Kouzen-machi, Nagasaki,
TEL	095-824-1101
Email	Satoshi2754@yahoo.co.jp

Public contact
Name of contact person	Satoshi Funakoshi
Organization	Nagasaki Kidney Hospital
Division name	Department of nephrology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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