UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055597 |
|---|---|
| Receipt number | R000063510 |
| Scientific Title | Pharmacist Remote Monitoring of Heart Failure Patients: A Prospective, Observational Study |
| Date of disclosure of the study information | 2024/09/24 |
| Last modified on | 2025/07/01 18:06:32 |
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Basic information
Public title
Pharmacist Remote Monitoring of Heart Failure Patients: A Prospective, Observational Study
Acronym
PHARE-HF (Pharmacy and Hospital Alliance on Remote Engagement in Heart Failure) Study
Scientific Title
Pharmacist Remote Monitoring of Heart Failure Patients: A Prospective, Observational Study
Scientific Title:Acronym
PHARE-HF (Pharmacy and Hospital Alliance on Remote Engagement in Heart Failure) Study
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective is to create use cases in real-world clinical settings through remote monitoring of heart failure patients by hospital and community pharmacists. Secondarily, the study aims to evaluate the effectiveness of pharmacist support in improving self-care, medication adherence, and health-related quality of life (HRQoL).
Basic objectives2
Others
Basic objectives -Others
Indicators for evaluating the effectiveness of pharmacist-led monitoring
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of information provided by pharmacists (information shared by hospital pharmacists with physicians and issuance of tracing reports by community pharmacists).
Number of community pharmacists' prescription suggestions and acceptance
Number of pharmacists' suggestions for consultation with the physician
Key secondary outcomes
Number of hospital pharmacists'prescription suggestions and acceptance
Number of patients monitored
Consent rate for research participation
Number of responses to the self-check questionnaire
Alert frequency
Alert follow-up
Insurance claims for CHOUZAIGO YAKUZAI SHIDOUKASAN2 (consultation after medication is given)
Satisfaction survey of healthcare professionals
Satisfaction survey of patients
European Heart Failure Self-care Behaviour Scale (EHFScBS) Japanese version
Morisky Medication Adherence Scale (MMAS) 4
MOS36-Item Short-Form Health Survey (SF-36)
Hospital readmission
Mortality
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Heart failure patients from Kurashiki Central Hospital or those using a study-affiliated pharmacy during the enrollment period
Aged 20 years or older at the consent
Informed consent
Patients who can operate electronic devices
Key exclusion criteria
Patients deemed inappropriate by healthcare professionals for the following reasons:
- Patients who are clearly unable to perform self-assessments due to mental illness or cognitive impairment
- Patients participating in other studies during the same period, which may interfere with the input required for self-monitoring in this study
- Patients deemed inappropriate by healthcare professionals
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takehito |
| Middle name | |
| Last name | Kame |
Organization
Public interest incorporated foundation Ohara HealthCare Foundation Kurashiki Central Hospital
Division name
Department of Pharmacy
Zip code
710-8602
Address
1-1-1 Miwa, Kurashiki, Okayama, Japan
TEL
086-422-0210
tk7441@kchnet.or.jp
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | |
| Last name | Kaichi |
Organization
Public interest incorporated foundation Ohara HealthCare Foundation Kurashiki Central Hospital
Division name
Department of Pharmacy
Zip code
710-8602
Address
1-1-1 Miwa, Kurashiki, Okayama, Japan
TEL
086-422-0210
Homepage URL
hk18030@kchnet.or.jp
Sponsor or person
Institute
Public interest incorporated foundation Ohara HealthCare Foundation Kurashiki Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Economy, Trade and Industry, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurashiki Central Hospital, Medical Ethics Committee
Address
1-1-1 Miwa, Kurashiki, Okayama, 710-8602 Japan
Tel
086-422-0210
www-adm@kchnet.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
公益財団法人大原記念倉敷中央医療機構 倉敷中央病院（岡山県）
ウエルシア薬局：岡山東島田店、岡山築港新町店、岡山浜店、岡山奉還町店、倉敷真備店、倉敷駅前店（岡山県）
金光薬局：岡山山崎店、倉敷店、倉敷昭和店、倉敷中庄店、水島神田店、倉敷福島店、大高店、新倉敷店、倉敷新田店、倉敷林店、金光店、児島柳田店、新倉敷西店（岡山県）
そうごう薬局：児島店、新倉敷店、中庄店、東塚店、水島中央店、南春日店（岡山県）
マスカット薬局：倉敷店、児島店（岡山県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 24 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 24 | 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
Interim analyses data will be presented soon
Management information
Registered date
| 2024 | Year | 09 | Month | 24 | Day |
Last modified on
| 2025 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063510
