UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044881 |
|---|---|
| Receipt number | R000051260 |
| Scientific Title | Suito-Ogaki selfcare trial |
| Date of disclosure of the study information | 2021/07/16 |
| Last modified on | 2021/10/04 09:59:12 |
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Basic information
Public title
Suito-Ogaki selfcare trial
Acronym
Suito-Ogaki selfcare trial
Scientific Title
Suito-Ogaki selfcare trial
Scientific Title:Acronym
Suito-Ogaki selfcare trial
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct an exploratory case-series study on the effects of pharmacists' guidance for lifestyle modification
Basic objectives2
Others
Basic objectives -Others
The effects of pharmacists' guidance for lifestyle modification
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of measurements and values of blood pressure, body weight, activity, blood turbidity during the observation period, and results of surveys on mental and physical frailty, behavior change, and pharmacists' guidance
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
pharmacists' guidance for lifestyle modification in accordance with guidelines for management of hypertension
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
(1) Those who can freely and voluntarily give their written consent to participate in the study.
(2) Be at least 20 years old at the time they wish to participate in the study
(3) Be able to manage their lifestyle at home using a device or smartphone application after receiving explanation from the pharmacist in charge
Key exclusion criteria
(1) Those who are undergoing medical examination for a chronic disease at the time they wish to participate in the study and have not received permission from their physician to participate
(2) Others who are judged by the pharmacist in charge to be inappropriate for participation in this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Hibino |
Organization
General Incorporated Association Ogaki Pharmacists Association
Division name
None
Zip code
503-0887
Address
2F, 1-80-5 Kuruwa-machi,Ogaki,Gifu Japan
TEL
0584-78-6666
gakiyaku@blue.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Hibino |
Organization
General Incorporated Association Ogaki Pharmacists Association
Division name
None
Zip code
503-0887
Address
2F, 1-80-5 Kuruwa-machi,Ogaki,Gifu Japan
TEL
0584-78-6666
Homepage URL
gakiyaku@blue.ocn.ne.jp
Sponsor or person
Institute
General Incorporated Association Ogaki Pharmacists Association
Institute
Department
Personal name
Funding Source
Organization
General Incorporated Association Japan Selfcare Promotion Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Academic research ethical review committee of Gifu pharmaceutical association
Address
4-5 Kokonoe-cho,Gifu,Gifu,Japan
Tel
058-260-8800
center@gifuyaku.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
サニー調剤薬局（岐阜県）、ケンコー薬局（岐阜県）、ラブダイイチ東薬局（岐阜県）、すずの木薬局（岐阜県）、中日調剤薬局 寺内店（岐阜県）、三笠堂薬局（岐阜県）、ヒグチ薬局（岐阜県）、ハロー薬局 大垣中央店（岐阜県）、ハロー薬局 大垣駅前店（岐阜県）、トーカイ薬局 安八店（岐阜県）、スギ薬局 中野店（岐阜県）、スギ薬局 垂井店（岐阜県）、ユタカ薬局 大垣旭町店（岐阜県）、ラブダイイチ大垣薬局（岐阜県）、金の鈴薬局 安八店（岐阜県）、ハーモニー調剤薬局 宮代店（岐阜県）、アイン薬局 大垣南店（岐阜県）、ハーモニー調剤薬局（岐阜県）、シノダ薬局 大垣店（岐阜県）、ラブダイイチながさわ薬局（岐阜県）、ハーモニー調剤薬局 桐ヶ崎店（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 16 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 14 | 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
| 2021 | Year | 07 | Month | 16 | Day |
Last modified on
| 2021 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051260
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
