UMIN-CTR Clinical Trial

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	No longer 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	2021 Year 03 Month 15 Day

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