UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057444 |
|---|---|
| Receipt number | R000065441 |
| Scientific Title | Validation of an Individualized IoT-based Self-Care Support Program for Chronic Heart Failure Patients |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/29 11:57:37 |
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Basic information
Public title
Validation of an Individualized IoT-based Self-Care Support Program for Chronic Heart Failure Patients
Acronym
Heart Failure Patient Self-Care Support Program Validation
Scientific Title
Validation of an Individualized IoT-based Self-Care Support Program for Chronic Heart Failure Patients
Scientific Title:Acronym
Heart Failure Patient Self-Care Support Program Validation
Region
| Japan |
Condition
Condition
Chronic heart failure
Classification by specialty
| Cardiology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Testing the effectiveness of an IoT-based program to support self-care for patients with chronic heart failure
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Self-Care Index (Japanese version of the Self-Care Rating Scale for Heart Failure 7.2)
Key secondary outcomes
Weight, blood pressure, number of steps, QOL (Japanese version of the questionnaire for cardiac tetany), general attributes (weight, blood pressure, number of steps, age, gender, primary disease, computer (type B) natrium diuretic peptide[BNP], left ventricular excretion rate [LVEF], period of treatment for cardiac insufficiency, number of hospital admissions, past history, cohabitant or not, employment or not, cognitive function (The)).Montreal Cognitive Assessment)
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
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Graphic feedback(weight, blood pressure, step count)
Phone Feedback
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Age 40 or older at the time of registration
2.Able to measure weight and blood pressure at home
3.Able to own and operate a smart phone
4.Written consent to participate in the research has been obtained from the research subject
Key exclusion criteria
Patients whose treatment policy regarding hospitalization, drugs, etc. has been changed during the study period
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Yamamoto |
Organization
Osaka Medical and Pharmaceutical University/Kyoto Prefectural Medical University
Division name
Graduate School of Nursing/ Department of Nursing, Faculty of Medicine
Zip code
569-0095
Address
7-6 Hachonishi-cho, Takatsuki-shi, Osaka, Japan
TEL
072-683-1221
hiroko@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Yamamoto |
Organization
Osaka Medical and Pharmaceutical University/Kyoto Prefectural Medical University
Division name
Graduate School of Nursing/ Department of Nursing, Faculty of Medicine
Zip code
569-0095
Address
7-6 Hachonishi-cho, Takatsuki-shi, Osaka, Japan
TEL
072-683-1221
Homepage URL
hiroko@koto.kpu-m.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical University, Research and Development Division
Address
2-7 Daigaku-cho, Takatsuki-shi, Osaka, Japan
Tel
072-683-1221
rinri@ompu.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
京都府立医科大学附属病院（京都市）/Kyoto Prefectural Medical University Hospital
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 03 | Month | 29 | Day |
Last modified on
| 2025 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065441
