UMIN-CTR Clinical Trial

Basic information
Public title	Research on patients with medication support equipment
Acronym	Research on patients with medication support equipment
Scientific Title	Research on patients with medication support equipment
Scientific Title:Acronym	Research on patients with medication support equipment
Region	Japan

Condition
Condition	Not specified
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Introduce medication support equipment to patient homes that require home visits, and confirm whether there are results such as improvement in medication adherence and reduction of burden on medication assistants.
Basic objectives2	Others
Basic objectives -Others	Improving medication adherence
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluate the average number of remaining medicines for 2 months before and after the introduction of medication support devices.
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	Educational,Counseling,Training
Type of intervention	Device,equipment
Interventions/Control_1	Introduction of medication support equipment for 2 months
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	Adults, mainly elderly
Key exclusion criteria	Minors
Target sample size	14

Research contact person
Name of lead principal investigator	1st name Takahashi Middle name Last name Yoshinori
Organization	Gunma Pharmaceutical Association
Division name	Officer
Zip code	371-0013
Address	5-18-36 Nishi-Katagai-machi, Maebashi City, Gunma Prefecture
TEL	027-243-6650
Email	gpa-dic@gunyaku.or.jp

Public contact
Name of contact person	1st name Miyata Middle name Last name Hikaru
Organization	Gunma Pharmaceutical Association
Division name	General Affairs Department Information Section
Zip code	371-0013
Address	5-18-36 Nishi-Katagai-machi, Maebashi City, Gunma Prefecture
TEL	027-243-6650
Homepage URL
Email	gpa-dic@gunyaku.or.jp

Sponsor
Institute	Gunma Pharmaceutical Association
Institute
Department

Funding Source
Organization	Gunma Prefectural Government Office
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Gunma Pharmaceutical Association
Address	5-18-36 Nishi-Katagai-machi, Maebashi City, Gunma Prefecture
Tel	027-243-6650
Email	rinri@gunyaku.or.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 08 Month 22 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	4
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 22 Day
Date of IRB	2019 Year 08 Month 15 Day
Anticipated trial start date	2019 Year 08 Month 22 Day
Last follow-up date	2020 Year 03 Month 23 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 08 Month 22 Day
Last modified on	2020 Year 08 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043053