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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038880
Receipt No. R000044336
Scientific Title Usefulness of telephone tracking after medication by pharmacists for patients with type 2 diabetes
Date of disclosure of the study information 2020/01/05
Last modified on 2020/02/12

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Basic information
Public title A study of the effect of telephone follow-up by pharmacists on diabetic patients
Acronym Phone follow-up study by pharmacists for diabetics
Scientific Title Usefulness of telephone tracking after medication by pharmacists for patients with type 2 diabetes
Scientific Title:Acronym Randomized controlled trial in which pharmacists follow phone calls for patients with type 2 diabetes
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of improving DTR-QOL and achieving better blood glucose control through pharmacist telephone intervention for patients with type 2 diabetes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Compare the DTR QOL of the intervention group and control group after 3 months with the baseline
Key secondary outcomes
HbA1c
Copmare mean increase or decrease values of intervention group and control group
Compliance and adherence
Compare the mean number of days prescribed for the intervention group and the control group divided by the interval between visits.
Remaining drug remaining drug amount
Compare the baseline and difference of the intervention group and control group after 3 months. The price is calculated at the price determined by the Ministry of Health Labor and Welfare.
Side effects sick days
Compare the percentage of all phone calls in the intervention group that found side effects and sick days.
Number of written reports to doctors
Compare the number of written submissions in the intervention and control groups the number of drug changes and dose changes.
Reduced drug
Compared the increase and decrease in the number of drugs in the diabetes prescription of the intervention group and the control group.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are 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 Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 In addition to regular care, the pharmacist calls five times for a total of three months. Based on "telephone follow contents". The contents are: (1) Confirmation of side effects such as hypoglycemia, (2) Response to sick days, (3) Confirmation of adherence from remaining drug status, (4) Confirmation of additional use of concomitant drugs and OTC drugs, (5) Confirmation of eating habits such as snacks, (6) Future pathological conditions and Anxiety about medication.
Confirm the above 6 points.
Interventions/Control_2 Normal care
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with type 2 diabetes who have been taking 2 or more oral antidiabetic drugs for more than 3 months.
The prescription time at the time of consent is 28 days or more.
Men and women over the age of 18 when obtaining consent.
Consent for study participation was obtained.
Patients who meet all of the above.
Key exclusion criteria Use of insulin injection, use of GLP-1 receptor agonist, home patient, dementia, diabetes completely cured during study period, hospitalized patient, drug management is third party, dialysis patient, lactating woman, alcohol / Drug addiction. Those who receive dietary guidance from a dietitian during the survey period. The above is excluded.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Hirose
Middle name
Last name Takashi
Organization Total Medical Service Co., Ltd.
Division name Sakura Pharmacy, Shingu Chuo Station
Zip code 811-0119
Address 4-17-4, Midorigahama, Kasuya Gun Shingu Machi, Fukuoka Ken, 811-0119, Japan
TEL 092-410-1194
Email takashi.hirose.tms@msnw.co.jp

Public contact
Name of contact person
1st name Hirose
Middle name
Last name Takashi
Organization Total Medical Service Co., Ltd.
Division name Sakura Pharmacy, Shingu Chuo Station
Zip code 811-0119
Address 4-17-4, Midorigahama, Kasuya Gun Shingu Machi, Fukuoka Ken, 811-0119, Japan
TEL 092-410-1194
Homepage URL
Email shinguchuoekimae@msnw.co.jp

Sponsor
Institute Total Medical Service Co., Ltd.
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical System Network Inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hokkaido Institute for Pharmacy Benefit Co.,Ltd
Address 2-1, Kita10-jonishi, Sapporo Shi Chuo Ku, Hokkaido, 060-0010, Japan
Tel 011-613-3577
Email rinri-shinsa@iyakusoken.com

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 九州、山口地区の(株)トータル・メディカルサービス所属の薬局

Other administrative information
Date of disclosure of the study information
2020 Year 01 Month 05 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
2020 Year 01 Month 04 Day
Date of IRB
2019 Year 12 Month 18 Day
Anticipated trial start date
2020 Year 01 Month 05 Day
Last follow-up date
2020 Year 05 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 12 Month 13 Day
Last modified on
2020 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044336

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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