UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050520 |
|---|---|
| Receipt number | R000057424 |
| Scientific Title | A multicenter single-arm study to evaluate physicians' and patients' acceptability of a heart failure app that nudges toward optimal medical therapy and overcomes clinical inertia. |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2023/09/21 16:16:24 |
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Basic information
Public title
A multicenter single-arm study to evaluate physicians' and patients' acceptability of a heart failure app that empowers toward better communication.
Acronym
A multicenter single-arm study to evaluate physicians' and patients' acceptability of a heart failure app that empowers toward better communication.
Scientific Title
A multicenter single-arm study to evaluate physicians' and patients' acceptability of a heart failure app that nudges toward optimal medical therapy and overcomes clinical inertia.
Scientific Title:Acronym
A multicenter single-arm study to evaluate physicians' and patients' acceptability of a heart failure app that nudges toward optimal medical therapy and overcomes clinical inertia.
Region
| Japan |
Condition
Condition
Heart failure with reduced ejection fraction(HFrEF)
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the acceptability of our novel heart failure app in the clinical setting.
Basic objectives2
Others
Basic objectives -Others
Usability and acceptability
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The percent of days the patient entered their health records in the app from the first day of app use to day 28.
Key secondary outcomes
1)Percentage of patients who had an initiation/intensification of GDMT at the first outpatient visit after inclusion.
2)Percentage of patients who had a reduction of GDMT at the first outpatient visit after inclusion.
3)SUS(system usability score) of the app
4)Qualitative details of the software malfunction
5)Patients' qualitative opinions on the app
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
| Device,equipment | Behavior,custom |
Interventions/Control_1
Use of a smartphone app that supports physicians and patients to efficiently discuss their heart failure medication regimen.
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.left ventricular ejection fraction (LVEF) of 40% or less on the most recent cardiology imaging study (at least within 1 year at the time of inclusion)
2.regularly visiting their cardiology outpatient clinic at intervals of approximately 28-56 days.
3.not receiving their Guideline Directed Medical Therapy at the maximum recommended dose described in the guidelines published by the Japanese Circulation Society.
4.can provide written consent to participate in the study of his/her own free will.
Key exclusion criteria
1.considered unable to use a smartphone.
2.unable to read Japanese
3.prognosis expected to be less than 1 year
4.receiving intravenous inotropic drugs
5.last laboratory value(at least within 3 months from the day of inclusion) of eGFR less than 15 mL/min/1.73 m2
6.equipped with a Left Ventricular Assist Device (LVAD)
7.NYHA classIV heart failure
8.on the waiting list for heart transplantation
9.pregnant, suspected to be pregnant, or lactating woman
10.judged by the investigator to be ineligible for participation in this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | Hayashi |
Organization
Oita University Faculty of Medicine
Division name
Department of Clinical Pharmacology and Therapeutics
Zip code
8795593
Address
1-1 Idaigaoka, Hasama-Machi, Yufu-Shi, Oita, 879-5593 Japan
TEL
0975865952
khayashi@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Hayashi |
Organization
Oita University Faculty of Medicine
Division name
Department of Clinical Pharmacology and Therapeutics
Zip code
8795593
Address
1-1 Idaigaoka, Hasama-Machi, Yufu-Shi, Oita, 879-5593 Japan
TEL
0975865952
Homepage URL
khayashi@oita-u.ac.jp
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
Funding Source
Organization
Daiwa Securities Health Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Oita University Hospital, Clinical Trial Ethics Committee
Address
1-1 Idaigaoka, Hasama-Machi, Yufu-Shi, Oita, 879-5593 Japan
Tel
097-586-6163
gcrcjimu@oita-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
1.大分大学医学部附属病院
2.名古屋市立大学医学部附属東部医療センター
3.獨協医科大学日光医療センター
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 31 | 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
5
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
| 2023 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 07 | Day |
Last modified on
| 2023 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057424
