UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010042 |
|---|---|
| Receipt number | R000011755 |
| Scientific Title | Substantiative study of adherence enhancement manual categorized by residual factors |
| Date of disclosure of the study information | 2013/02/15 |
| Last modified on | 2013/09/17 15:42:13 |
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Basic information
Public title
Substantiative study of adherence enhancement manual categorized by residual factors
Acronym
Substantiative study of manual categorized by residual factors
Scientific Title
Substantiative study of adherence enhancement manual categorized by residual factors
Scientific Title:Acronym
Substantiative study of manual categorized by residual factors
Region
| Japan |
Condition
Condition
chronic disease
Classification by specialty
| Medicine in general | Obstetrics and Gynecology | Dermatology |
| Oto-rhino-laryngology | Orthopedics | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Aiming to improve the medication adherence of the patients with chronic diseases, prepare the "Manual for the care according to the unused medicines factors" for the community pharmacists, and clarify the clinical utility.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Community pharmacists: The rate to find unused medicines among the patients with chronic diseases.
The rate to solve problems.
(It records for one week at the time of baseline, one month after intervention, and three months after.)
Key secondary outcomes
Community pharmacists:consciousness for the medication adherence.
Patients with chronic diseases:Unused medicine rate. Medication consciousness.
(A self-reported questionnaire is carried out for one week at the time of baseline and one month after intervention. )
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Community pharmacy is an allotment unit.Randomly allocate either the intervention group or the controlled group to each Community pharmacy.
All the pharmacists who may carry out the pharmaceutical care shall receive the training. After the training, the pharmacists shall confirm the unused medicines and solve the problem based on the Manual
Interventions/Control_2
Carry out the ordinary pharmaceutical 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
[Pharmacy / Pharmacist]
1. To agree with the purpose of this empirical research, and to hope to participate in it
2. More than 30% of the visiting patients are with chronic diseases
3. To be able to have all the pharmacists that will carry out the medication guidance receive the training in one way or another
[Patients with chronic disease]
1.Aged 90 and below aged 30 and over
2.To be the patient with a chronic disease that has been receiving the continuous treatment
3. Even the patients that came for the first time, if he/she were receiving therapeutic medicine of the chronic disease, it can be a research object
Key exclusion criteria
[Pharmacy / Pharmacist]
1. The pharmacies that have only one pharmacist on duty
[Patients with chronic disease]
1. The patient who cannot administer the medicine by him/herself
2. Patients with mental disorder
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiko Goto |
Organization
TOKYO UNIVERSITY OF SIENCE
Division name
Faculty of Pharmaceutical sciences
Zip code
Address
2641,Yamazaki,Noda-Chiba,Japan
TEL
04-7121-4108
kgoto@rs.noda.tus.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Goto |
Organization
TOKYO UNIVERSITY OF SIENCE
Division name
Faculty of Pharmaceutical sciences
Zip code
Address
2641,Yamazaki,Noda-Chiba,Japan
TEL
04-7121-4108
Homepage URL
kgoto@rs.noda.tus.ac.jp
Sponsor or person
Institute
Laboratory of health psychology, Faculty of Pharmaceutical sciences, TOKYO UNIVERSITY OF SIENCE
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Faculty of Pharmacy, Meijyo University
School of education,Waseda University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 02 | Month | 15 | 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
Completed
Date of protocol fixation
| 2013 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 06 | Day |
Date of closure to data entry
| 2013 | Year | 07 | Month | 12 | Day |
Date trial data considered complete
| 2013 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 14 | Day |
Last modified on
| 2013 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011755
