UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043161
Receipt number R000048124
Scientific Title Effect of diabetes educational program for prevent the hypoglycemia in pharmacies: A cluster Randomized Controlled Trial
Date of disclosure of the study information 2021/02/01
Last modified on 2023/09/27 10:44:40

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Basic information

Public title

Effect of diabetes educational program for prevent the hypoglycemia in pharmacies: A cluster Randomized Controlled Trial

Acronym

Effect of diabetes educational program for prevent the hypoglycemia in pharmacies: A cluster Randomized Controlled Trial

Scientific Title

Effect of diabetes educational program for prevent the hypoglycemia in pharmacies: A cluster Randomized Controlled Trial

Scientific Title:Acronym

Effect of diabetes educational program for prevent the hypoglycemia in pharmacies: A cluster Randomized Controlled Trial

Region

Japan


Condition

Condition

diabetes mellitus

Classification by specialty

Endocrinology and Metabolism Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To test whether pharmacists' use of the Sick Day card (developed by the researchers) in teaching diabetic patients will improve patients' understanding of sick day and what to do when sick day occurs.

Basic objectives2

Others

Basic objectives -Others

Examine the impact of the Sick Day Card initiative on pharmacists.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Differences between the two groups of changes in patient anxiety, motivation, and attitude scores measured by a questionnaire survey

Key secondary outcomes

Comparison of the number of hypoglycemias.
Confirmation of Appropriate response during sick day.
Existence of doctor's instructions.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Use sick day card for medicine notebook

Interventions/Control_2

Not use sick day card for medicine notebook

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)Patients who are 20 years old or more at the time of consent acquisition.
(2) Patients provided informed consent
(3)Patients who have been issued prescriptions by medical institutions

Key exclusion criteria

(1)Requested for cancellation from patients
(2)Interrupted due to the circumstances of the research patients (moving, changing doctor / hospital, busy, unfollowable)
(3)Judged that evaluation is not possible due to serious deviation from protocol
(4)Patients judged inappropriate in this study

Target sample size

600


Research contact person

Name of lead principal investigator

1st name keisuke
Middle name
Last name kado

Organization

KRAFT HONSHA Inc.

Division name

kyoikukikakubu

Zip code

100-8225

Address

PALACE building-10F,1-1-1,Marunouchi,Tiyoda-ku,Tokyo,Japan

TEL

03-5208-9800

Email

k-kado@kraft-net.co.jp


Public contact

Name of contact person

1st name keisuke
Middle name
Last name kado

Organization

KRAFT HONSHA Inc.

Division name

kyoikukikakubu

Zip code

100-8225

Address

PALACE building-10F,1-1-1,Marunouchi,Tiyoda-ku,Tokyo,Japan

TEL

03-5208-9800

Homepage URL


Email

k-kado@kraft-net.co.jp


Sponsor or person

Institute

KRAFT HONSHA Inc.

Institute

Department

Personal name



Funding Source

Organization

KRAFT HONSHA Inc.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Health Informatics, Kyoto University School of Public Health
KRAFT Inc.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

KRAFT Inc. Institutional Review Board

Address

PALACE building-10F,1-1-1,Marunouchi,Tiyoda-ku,Tokyo,Japan

Tel

03-5208-9800

Email

rinriiinkai@kraft-net.co.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

2021 Year 02 Month 01 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

318

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

2021 Year 01 Month 21 Day

Date of IRB

2021 Year 01 Month 21 Day

Anticipated trial start date

2021 Year 02 Month 01 Day

Last follow-up date

2023 Year 09 Month 30 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 01 Month 28 Day

Last modified on

2023 Year 09 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048124


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name