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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031668
Receipt No. R000036169
Scientific Title Individualized intervention by community pharmacists for supporting self-care of diabetic patients: Implementation of the tool predicting poor medication adherence with collaborative interviewing
Date of disclosure of the study information 2018/03/11
Last modified on 2019/10/03

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Basic information
Public title Individualized intervention by community pharmacists for supporting self-care of diabetic patients: Implementation of the tool predicting poor medication adherence with collaborative interviewing
Acronym Self-care support of diabetic patients by community pharmacists using the tool predicting poor medication adherence
Scientific Title Individualized intervention by community pharmacists for supporting self-care of diabetic patients: Implementation of the tool predicting poor medication adherence with collaborative interviewing
Scientific Title:Acronym Self-care support of diabetic patients by community pharmacists using the tool predicting poor medication adherence
Region
Japan

Condition
Condition Type 2 diabetic patients
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine psychosocial metrics, treatment attitude and behavior, and QOL of the diabetic patients who receive individualized intervention from community pharmacists via collaborative interviewing.
Basic objectives2 Others
Basic objectives -Others Treatment attitude and behavior
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Problem areas in Diabetes (PAID) Score (at the 6th and 12th month)
Key secondary outcomes - HbA1c
- QOL (EU-5D-5L,VAS)
- Medication Adherence
- Treatment motivation
All the above items to be evaluated at the 6th and 12th month.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Community pharmacists examine in advance the probability of poor medication adherence of subjects using a newly developed "Risk predicting tool for medication adherence" and implement self-care support depending on each subject's profile of illness insight. In principle, intervention is to be executed at the time when subjects visit community pharmacies for 6 to 12 months. The number of interventions (collaborative interviewing) differ for each subject.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Type 2 diabetic patients who receive outpatient medication and meet the following:
(1) To have had at least 6 months, but not more than 10 years, since the medical treatment for diabetes initiated.
(2) To own a diabetes collaboration notebook and agree provision of copies of relevant medical records.
(3) To agree to cooperate with collecting required data; such as filling out the questionnaires at the start, 6th, and 12th month, responding to interviewing and phone-contacting.
Key exclusion criteria Among the subjects who satisfy the inclusion criteria, those who able unable to communicate, read, and write in the Japanese language.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mayumi Mochizuki
Organization Keio University, Faculty of Pharmacy
Division name Division of Hospital Pharmacy Science
Zip code
Address 1-5-30 Shibakoen, Minato-ku, Tokyo 105-8512, Japan
TEL 03-5400-2486
Email mochizuki-my@pha.keio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiko Tominaga
Organization Keio University, Faculty of Pharmacy
Division name Division of Hospital Pharmacy Science
Zip code
Address 1-5-30 Shibakoen, Minato-ku, Tokyo 105-8512, Japan
TEL 03-5400-2486
Homepage URL
Email y-tominaga.pha@keio.jp

Sponsor
Institute Keio University, Faculty of Pharmacy, Division of Hospital Pharmacy Science
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 ツルハ薬局17軒(東京、山梨、茨城、神奈川)、なの花薬局5軒(東京、神奈川、静岡)、上田薬剤師会会員薬局9軒(長野)、市民調剤薬局1軒(新潟)、総合メディカル14軒(岩手、福島、宮城、茨城、群馬、栃木、埼玉、千葉、東京、神奈川、静岡、富山)、さくら薬局13軒(茨城、栃木、群馬)、ホームケアファーマシー1軒(鹿児島)



Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 11 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 Open public recruiting
Date of protocol fixation
2017 Year 10 Month 20 Day
Date of IRB
2017 Year 10 Month 20 Day
Anticipated trial start date
2018 Year 03 Month 12 Day
Last follow-up date
2021 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
2018 Year 03 Month 11 Day
Last modified on
2019 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036169

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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