UMIN-CTR Clinical Trial

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
Email	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
Email	shoji@gly.oups.ac.jp

Sponsor
Institute	Osaka University of Pharmaceutical Sciences
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042143