UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038880 |
|---|---|
| Receipt number | 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 | 2022/03/22 16:37:58 |
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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
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
shinguchuoekimae@msnw.co.jp
Sponsor or person
Institute
Total Medical Service Co., Ltd.
Institute
Department
Personal name
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
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
Terminated
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
| 2022 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044336
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/03/22 | ＴＭＳテレフォンフォローアップ研究計画書.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
