UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038198 |
|---|---|
| Receipt number | R000043537 |
| Scientific Title | Exploratory intervention study of elderly hypertensive patients using tools to keep track of their medication |
| Date of disclosure of the study information | 2019/10/03 |
| Last modified on | 2021/04/06 13:40:42 |
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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
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
kikuchi@phar.nagoya-cu.ac.jp
Sponsor or person
Institute
Graduate school of pharmaceutical Science, Nagoya City university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043537
