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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041671
Receipt No. R000047563
Scientific Title Evaluation of community pharmacist-provided telephone interventions to improve adherence of SSRI/SNRI-treated patients
Date of disclosure of the study information 2020/09/04
Last modified on 2020/09/03

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Basic information
Public title Evaluation of community pharmacist-provided telephone interventions to improve adherence of SSRI/SNRI-treated patients
Acronym Evaluation of community pharmacist-provided telephone interventions to SSRI/SNRI-treated patients
Scientific Title Evaluation of community pharmacist-provided telephone interventions to improve adherence of SSRI/SNRI-treated patients
Scientific Title:Acronym Evaluation of community pharmacist-provided telephone interventions to SSRI/SNRI-treated patients
Region
Japan

Condition
Condition Depression
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study examines the effect of community pharmacist-provided telephone interventions to improve adherence of SSRI/SNRI-treated patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Treatment persistence rate
Key secondary outcomes DAI-10, medication adherence, Pharmacy satisfaction, Utilization of CBT-A

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 3-month treatment persistence rate for the group of usual medication guidance plus telephone support (intervention group)
1.Telephone support is provided 3 times in the middle of the day before the next scheduled visit to the clinic.
2. If any side effects are found, Pharmacist will respond to them according to the protocol.
3.Support for anxiety about medication is provided through the cognitive-behavioral therapy approach (CBT-A).
Interventions/Control_2 Treatment persistence rate at 3 months in the usual medication guidance group (control group)
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients being prescribed an SNRI/SSRI for the first time
2.Patients who visit a clinic where the research co-investigator works and bring a prescription issued by the clinic to the research co-investigator's pharmacy
Key exclusion criteria 1.Patients in the hospital
2.Patients who were previously prescribed SNRI/SSRI
3.Men and women under the age of 20
4.Patients who did not get their consent to participate in the study
Target sample size 130

Research contact person
Name of lead principal investigator
1st name Fumiyuki
Middle name
Last name Watanabe
Organization School of Pharmacy, Nihon University
Division name Laboratory of Pharmacy practice in primary care
Zip code 274-8555
Address 7-7-1 Narashinodai, Funabashi, Chiba, Japan
TEL 047-465-7394
Email watanabe.fumiyuki@nihon-u.ac.jp

Public contact
Name of contact person
1st name Fumiyuki
Middle name
Last name Watanabe
Organization School of Pharmacy, Nihon University
Division name Laboratory of Pharmacy practice in primary care
Zip code 274-8555
Address 7-7-1 Narashinodai, Funabashi, Chiba, Japan
TEL 047-465-7394
Homepage URL
Email watanabe.fumiyuki@nihon-u.ac.jp

Sponsor
Institute School of Pharmacy, Nihon University
Institute
Department

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 Ethics Review Committee, School of Pharmacy, Nihon University
Address 7-7-1 Narashinodai, Funabashi, Chiba, Japan
Tel 047-465-5919
Email pha.res-staff@nihon-u.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
2020 Year 09 Month 04 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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 08 Day
Date of IRB
2020 Year 07 Month 08 Day
Anticipated trial start date
2020 Year 09 Month 04 Day
Last follow-up date
2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 09 Month 03 Day
Last modified on
2020 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047563

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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