UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026618 |
|---|---|
| Receipt number | R000030570 |
| Scientific Title | the effectiveness of medication instructions for medication adherence in psychiatric patients |
| Date of disclosure of the study information | 2017/03/22 |
| Last modified on | 2021/09/22 17:57:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
the effectiveness of medication instructions for medication adherence in psychiatric patients
Acronym
the effectiveness of medication instructions for medication adherence in psychiatric patients
Scientific Title
the effectiveness of medication instructions for medication adherence in psychiatric patients
Scientific Title:Acronym
the effectiveness of medication instructions for medication adherence in psychiatric patients
Region
| Japan |
Condition
Condition
Diagnosis of psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders-fifth edition (DSM-5)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify how medication instruction by pharmacist affects medication adherence in patients with psychiatric disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Drug Attitude Inventory-30
(At hospitalization,At the start of taking medicine myself,At the start of medication instruction,At discharge)
Key secondary outcomes
Drug Attitude Inventory-10
(At hospitalization,At the start of taking medicine myself,At the start of medication instruction,At discharge)
Adherence confirmed by the pill count method
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Starting taking medicine by self-management from the time the doctor judges it possible.
After 2 weeks taking medicine by self-management, pharmacists conducted medication instruction until discharge.
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient who the attending physician judged possible to participate.
Received informed consent.
Key exclusion criteria
Patient who the attending physician judged impossible to participate.
Unreceived informed consent.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Tokutani |
Organization
The Hospital of Hyogo College of Medicine
Division name
Department of pharmacy
Zip code
663-8501
Address
1-1 Mukogawacho,Nishinomiya,Hyogo,Japan
TEL
0798-45-6189
yktokuta@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Tokutani |
Organization
The Hospital of Hyogo College of Medicine
Division name
Department of pharmacy
Zip code
658-8501
Address
1-1 Mukogawacho,Nishinomiya,Hyogo,Japan
TEL
0798-45-6189
Homepage URL
yktokuta@hyo-med.ac.jp
Sponsor or person
Institute
Department of pharmacy,The Hospital of Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of pharmacy,The Hospital of Hyogo College of Medicine
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
The Hospital of Hyogo College of Medicine
Address
1-1 Mukogawacho,Nishinomiya,Hyogo,Japan
Tel
0798-45-6006
chiken02@hyo-med.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
| 2017 | Year | 03 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2030 | Year | 10 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 20 | Day |
Last modified on
| 2021 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030570
