UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory intervention study of elderly hypertensive patients using tools to keep track of their medication
Acronym	Exploratory intervention study of elderly hypertensive patients using tools to keep track of their medication
Scientific Title	Exploratory intervention study of elderly hypertensive patients using tools to keep track of their medication
Scientific Title:Acronym	Exploratory intervention study of elderly hypertensive patients using tools to keep track of their medication
Region	Japan

Condition
Condition	hypertension
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To collect data by introducing tools to keep track of medication to patients with poor medication adherence.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	None(Exploratory intervention study)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Installation of tools to check medication. Medication instruction based on information obtained from the tool.
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Age 65 or older at the time of consent 2)Taking one or more antihypertensive drugs 3)Taking drugs (including non-antihypertensive drugs) 2 to 4 times a day 4)Medications are packaged in one-dose 5)Systolic blood pressure 130 mmHg or higher at home or hospital 6)Poor medication adherence (correspond to either or both of (1) or (2)) (1)Medication Possession Ratio (MPR)*1 in the last two months is less than 90% or 110% or more (2)One or more of the drug management issues*2
Key exclusion criteria	1)Pharmacist give home-care 2)Principal investigator may consider that assistance is required to take medicine 3)Residing in a place where the principal investigator cannot go within 2 hours 4)Principal investigator may consider unsuitable for participants
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Chigusa Middle name Last name Kikuchi
Organization	Graduate school of pharmaceutical Science, Nagoya City University
Division name	Department of Clinical Pharmacy
Zip code	4678603
Address	3-1 Tanabe-dori, Mizuho-ku, Nagoya
TEL	0528363460
Email	kikuchi@phar.nagoya-cu.ac.jp

Public contact
Name of contact person	1st name Chigusa Middle name Last name Kikuchi
Organization	Graduate school of pharmaceutical Science, Nagoya City university
Division name	Department of Clinical Pharmacy
Zip code	4678603
Address	3-1 Tanabe-dori, Mizuho-ku, Nagoya
TEL	0528363460
Homepage URL
Email	kikuchi@phar.nagoya-cu.ac.jp

Sponsor
Institute	Graduate school of pharmaceutical Science, Nagoya City university
Institute
Department

Funding Source
Organization	Pfizer Health Research Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Nagoya City University Hospital Clinical Research Review board
Address	1 Kawasumi, Mizuho-ku, Nagoya
Tel	+81-52-851-5511
Email	clinical_research@med.nagoya-cu.ac.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

Other administrative information
Date of disclosure of the study information	2019 Year 10 Month 03 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	2019 Year 08 Month 28 Day
Date of IRB	2019 Year 09 Month 09 Day
Anticipated trial start date	2019 Year 10 Month 07 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 03 Day
Last modified on	2021 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043537