UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046750 |
|---|---|
| Receipt number | R000053216 |
| Scientific Title | Evaluation of the effect of regular patient guidance by insurance pharmacy pharmacists and provision of information to hospitals on heart failure management |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2025/03/21 14:31:41 |
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Basic information
Public title
Evaluation of the effect of regular patient guidance by insurance pharmacy pharmacists and provision of information to hospitals on heart failure management
Acronym
Evaluation of the Effectiveness of Insurance Pharmacy Pharmacist Intervention for Heart Failure Patients
Scientific Title
Evaluation of the effect of regular patient guidance by insurance pharmacy pharmacists and provision of information to hospitals on heart failure management
Scientific Title:Acronym
Evaluation of the Effectiveness of Insurance Pharmacy Pharmacist Intervention for Heart Failure Patients
Region
| Japan |
Condition
Condition
Chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the Effectiveness of Insurance Pharmacy Pharmacist Intervention for Heart Failure Patients
chronic heart failure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Initial readmissions, emergency room visits and fatal events due to worsening of chronic heart failure
Key secondary outcomes
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
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
Guidance, medical treatment support, and information provision by an insurance pharmacy pharmacist once every two weeks for one year
Interventions/Control_2
Interventions as existing for one year
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who were hospitalized for heart failure treatment at the time of consent acquisition and are scheduled to visit the Department of Cardiology as an outpatient for heart failure after discharge.
2.Patients who have been diagnosed as AHA stage C heart failure.
3. Patients who are 18 years old or older at the time of obtaining consent.
4. Patients who have a specific pharmacy to dispense prescriptions.
Key exclusion criteria
1.Patients who have difficulty in voluntarily agreeing to participate in this study.
2. Patients with serious disorders (renal, hepatic, hematological, respiratory, digestive, neuropsychiatric, metabolic, etc.) who are judged by the attending physician to be ineligible for this study.
3. Patients who have difficulty or refuse to come to our hospital.
4. Other patients who are judged by the attending physician to be ineligible for this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Terashima |
Organization
Tosei general hospital
Division name
Pharmaceutical department
Zip code
489-8642
Address
160, Nishi-Oiwake-cho, Seto City, Aichi Prefecture, Japan
TEL
+81-561-82-5101
c212806@ed.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Terashima |
Organization
Tosei general hospital
Division name
Pharmaceutical department
Zip code
489-8642
Address
160, Nishi-Oiwake-cho, Seto City, Aichi Prefecture, Japan
TEL
+81-561-82-5101
Homepage URL
c212806@ed.nagoya-cu.ac.jp
Sponsor or person
Institute
Tosei general hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagoya City University Graduate School of Pharmaceutical Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tosei general hospital medical ethics committee
Address
160, Nishi-Oiwake-cho, Seto City, Aichi Prefecture, Japan
Tel
+81-561-82-5101
ychikenn@tosei.or.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
| 2022 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://jphcs.biomedcentral.com/articles/10.1186/s40780-025-00426-5
Number of participants that the trial has enrolled
71
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
| 2021 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 27 | Day |
Last modified on
| 2025 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053216
