UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061492 |
|---|---|
| Receipt number | R000070364 |
| Scientific Title | Survey on Real-World Usage of a Mobile Application for Self-Management of Chronic Heart Failure |
| Date of disclosure of the study information | 2026/05/08 |
| Last modified on | 2026/05/08 15:57:09 |
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Basic information
Public title
Survey on Real-World Usage of a Mobile Application for Self-Management of Chronic Heart Failure
Acronym
Follow-up Survey of the Heart Failure Management App
Scientific Title
Survey on Real-World Usage of a Mobile Application for Self-Management of Chronic Heart Failure
Scientific Title:Acronym
Follow-up Survey of the Heart Failure Management App
Region
| Japan |
Condition
Condition
Chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate usage patterns of the app following its release by analysing life log data (e.g. daily blood pressure, pulse and weight) and heart failure symptom data obtained from patients with chronic heart failure who have installed and used the app. The app is being released on a limited basis. The aim is to use the feedback and evaluations received to improve the programming, user interface (UI) and user experience (UX) of the app in future versions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Three-month retention rate for the app
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with chronic heart failure (regardless of treatment or underlying conditions)
2) Owners of a smartphone capable of connecting to the internet
3) Individuals who have provided informed consent to participate in the study
4) Aged 18 years or older
Key exclusion criteria
1) Patients who are unable to use a smartphone (or use the app) due to cognitive or physical decline or impairment;
2) Patients who have withdrawn their consent to participate in this study;
3) Patients whom the principal investigator or co-investigator deems unsuitable for inclusion in the study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Dohi |
Organization
Mie University Graduate School ofMedicine
Division name
Department of Cardiology and Nephrology
Zip code
5148507
Address
Edobashi 2-174, Tsu, Mie, Japan
TEL
0592315015
dohik@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromasa |
| Middle name | |
| Last name | Ito |
Organization
Mie University Hospital
Division name
Depatment of Cardiology
Zip code
5148507
Address
Edobashi 2-174, Tsu, Mie, Japan
TEL
0592321111
Homepage URL
h-ito@med.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
Mie University
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 Clinical Research Ethics Review Committiee of Mie University Hospital
Address
Edobashi 2-174, Tsu, Mie, Japan
Tel
0592315045
kk-sien@med.mie-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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Baseline Assessment Items
At the time of initial app registration\
Basic information (gender, date of birth, email address)
Lifestyle habits (wake-up time, bedtime, meal times, smoking habits, drinking habits, exercise habits)\
Underlying conditions (underlying diseases related to chronic heart failure)
Ideal weight, height
KCCQ score, EQ-5D score
Information on primary care physician
Status of visits to medical institutions
Medication information (obtained via JAHIS-compatible QR code or Myna Portal integration *Optional)
Health checkup information (obtained via Myna Portal integration *Optional)
Medical expense information (obtained via Myna Portal integration *Optional)
Evaluation items during the observation period
Items entered daily by study participants using this app
Systolic blood pressure, diastolic blood pressure, pulse rate, weight
Subjective symptoms: Shortness of breath on exertion, edema, cough, loss of appetite, shortness of breath at rest
Weather information (Combines weather data obtained via API with approximate location data at the time of entry [based on postal code area])
Physical activity (step count)
Evaluation items at assessment points (3 months, 6 months, 1 year, 2 years)
App usage time, time of day, and number of items entered
Questionnaire: Evaluation items regarding app usage and health literacy
Systolic blood pressure, diastolic blood pressure, pulse rate, weight
Self-reported symptoms: Shortness of breath on exertion, edema, cough, loss of appetite, shortness of breath at rest
Physical activity (step count)
KCCQ score, EQ-5D score
Questionnaire regarding medical consultation status
Management information
Registered date
| 2026 | Year | 05 | Month | 08 | Day |
Last modified on
| 2026 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070364
