UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048737 |
|---|---|
| Receipt number | R000047369 |
| Scientific Title | Verification of the effect of assistance application for medication. -Randomized controlled trial- |
| Date of disclosure of the study information | 2022/08/24 |
| Last modified on | 2024/03/01 19:14:10 |
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Basic information
Public title
Verification of the effect of assistance application for medication. -Randomized controlled trial-
Acronym
Verification of the effect of assistance application for medication.
Scientific Title
Verification of the effect of assistance application for medication. -Randomized controlled trial-
Scientific Title:Acronym
Verification of the effect of assistance application for medication.
Region
| Japan |
Condition
Condition
The patient of hypertention, diabetes, Dyslipidemia
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of a smartphone-based support tool in improving medication adherence rates and adherence to medication
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Medication adherence rate
Key secondary outcomes
MMAS-8 score, change in MMAS-8 score before and after intervention, percentage of medication noncompliance (medication compliance less than 80%), percentage of medication compliance by age/sex/disease
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Medication support tool as a smartphone application
Interventions/Control_2
No intaervention
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
People who are 40 years of age or older and are taking regular medication for lifestyle-related diseases (hypertension, diabetes or dyslipidemia)
Smartphone users who are able to install LINE and register as LINE friends to use the medication support tool.
People who are not taking any prescription or over-the-counter drugs other than those dispensed by the target dispensing pharmacy.
Persons who understand the content of the study and who can voluntarily agree to participate in the study.
Key exclusion criteria
Those who cannot manage their own medication
Persons whose smartphone version or model is not compatible with the LINE application
Prescribers with prescriptions of less than 21 days
Persons whose prescriptions are not stable (those who have had a change in prescriptions related to lifestyle-related diseases within the past 3 months of inclusion and those who plan to change their prescriptions during the intervention period)
Other persons deemed inappropriate by the researcher.
Target sample size
190
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Iwami |
Organization
Kyoto University
Division name
Graduate School of medicine
Zip code
606-8501
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto-city
TEL
075-753-4400
iwami.taku.8w@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Tateyama |
Organization
Kyoto Univestity
Division name
Graduate school of medicine
Zip code
606-8501
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto-city
TEL
075-753-4400
Homepage URL
https://yobou.med.kyoto-u.ac.jp/wp-content/uploads/2021/04/f8b1d26af3a78779889c6f4872a04761.pdf
iwami.taku.8w@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medecine
Institute
Department
Personal name
Funding Source
Organization
Healthtech labolatory Inc.
TOWA PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto university Graduate school and faculty of medicine, ethics committee
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
総合メディカル株式会社
はやぶさ薬局阪神千鳥橋店
とおやま薬局
長野台薬局
ナズミ薬局
木下薬局
さくら薬局
はしづめ薬局並松店
つばさ薬局
プラチナ薬局水明台店
てるてる薬局
あんず薬局谷町店
アビス薬局土居店
ウエストゲート薬局
茨木撫子薬局
みのり薬局
ナオール薬局宿院店
きたしらかわ薬局
ベルデ薬局新三田店
ピースマイル薬局うめきた店
なごみ薬局
コアラ薬局 光明池店
サポート薬局恵比寿店
スマイル薬局
八仙堂薬局滝内店
カトウ薬局
有限会社かんまき薬局
あゆみ薬局竹見台店
シンバシ薬局四條畷店
枚方マルゼン薬局
ユニカムドラッグ少路薬局
OSファーマシー
シンバシ薬局
わかたけ薬局
たけのこ調剤薬局伊丹店
柏原もみじ薬局
ニコニコ薬局
きし薬局下戸田店
みどり薬局
みやび薬局日根野
ハンワ薬局
フミヨ薬局
カルナ薬局
みつき調剤薬局
ヘルシー21スミヨシ薬局今福店
ヘルシー21スミヨシ薬局蒲生店
山田薬局
エンド薬局
ゆうせい薬局
ライフ薬局
メディセレ薬局
さざなみ薬局
今里コスモス薬局
ふじ薬局
なごみ薬局
西鈴駅前さくら薬局
しきさい薬局神戸西店
しろくま薬局
さら薬局
エン薬局長浜風の街店
ニシムラ薬局
マロン薬局
りんご薬局
保険調剤ナンバーワン薬局
サンプラザ調剤薬局
ならの木薬局大原野店
フジタ薬局高野店
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 24 | 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 | 01 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 08 | Month | 24 | Day |
Last modified on
| 2024 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047369
