UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037954 |
|---|---|
| Receipt number | R000042143 |
| Scientific Title | Effects of Community Pharamcists' Medication Assisst for the Patients Taking Antihypertensives |
| Date of disclosure of the study information | 2019/09/10 |
| Last modified on | 2022/04/11 11:11:50 |
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Basic information
Public title
Effects of Community Pharamcists' Medication Assisst for the Patients Taking Antihypertensives
Acronym
Effects of Community Pharamcists' Medication Assisst for the Patients Taking Antihypertensives
Scientific Title
Effects of Community Pharamcists' Medication Assisst for the Patients Taking Antihypertensives
Scientific Title:Acronym
Effects of Community Pharamcists' Medication Assisst for the Patients Taking Antihypertensives
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Determine whether medication support based on cognitive behavioral therapy by pharmacy pharmacists improves adherence for patients taking antidepressants.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Medication Adherence during the intervention period (6 months)
Key secondary outcomes
QOL, Cost-effectiveness, Severity of the disease, The relationship between pharmacists and patients
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Medication support based on cognitive behavioral therapy
Interventions/Control_2
Medication consultation by phone
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with depression
Key exclusion criteria
Dementia, bipolar, schizophrenia, patients who have difficulty in answering questionnaires
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Mitsuko |
| Middle name | |
| Last name | Onda |
Organization
Osaka University of Pharmaceutical Sciences
Division name
laboratory of Social and Administrative Pharmacy
Zip code
569-1094
Address
4-20-1, Nasahara Takatsuki, Osaka, Japan
TEL
072-690-1059
onda@gly.oups.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Shoji |
Organization
Osaka University of Pharmaceutical Sciences
Division name
laboratory of Social and Administrative Pharmacy
Zip code
569-1094
Address
4-20-1, Nasahara Takatsuki, Osaka, Japan
TEL
072-690-1059
Homepage URL
shoji@gly.oups.ac.jp
Sponsor or person
Institute
Osaka University of Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Public Interest Incorporated Foundation The Health Care Science Institute
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
Osaka University of Pharmaceutical Sciences, Research Ethics Committee
Address
4-20-1, Nasahara Takatsuki, Osaka, Japan
Tel
072-690-1103
kenkyus@gly.oups.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 10 | 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
31
Results
Nineteen participants in the intervention group and 12 in the control group completed the study. The intervention group tended to have higher DAI-10 scores (dIG: 1.059, dCG: -2.000; p=0.035) and PHQ-9 scores (dIG: 0.813, dCG: -2.818; p=0.049)than the control group
Results date posted
| 2020 | Year | 09 | Month | 07 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Due to a delay in recruitment.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
At the beginning of the study, 25 participants were enrolled in the IG and 14 in the CG; however, six participants from the IG and two from the CG dropped out of the study during follow-up. Nineteen participants in the IG and 12 in the CG completed the study.
Adverse events
No adverse events have been reported as a result of this study.
Outcome measures
Drug Attitude Investigator(DAI)-10,
Patient Health Questionnaire(PHQ)-9,
EQ-5D5L,
Patient Satisfaction,
The pharmacists' confidence scale about medication consultation for depressive patients(PCMCD)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 12 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 06 | Day |
Last modified on
| 2022 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042143
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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