UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031668 |
|---|---|
| Receipt number | 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 | 2021/03/15 08:43:02 |
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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
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
y-tominaga.pha@keio.jp
Sponsor or person
Institute
Keio University, Faculty of Pharmacy, Division of Hospital Pharmacy Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036169
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