UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047676 |
|---|---|
| Receipt number | R000054360 |
| Scientific Title | The impact of application-based management of heart failure by using internet of things |
| Date of disclosure of the study information | 2022/05/08 |
| Last modified on | 2023/05/10 09:18:36 |
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Basic information
Public title
The impact of application-based management of heart failure by using internet of things
Acronym
IAM-HF
Scientific Title
The impact of application-based management of heart failure by using internet of things
Scientific Title:Acronym
IAM-HF
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether self-care of heart failure is improved after changing its medium from a notebook to a specific application with internet of things in adult patients with HF.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the scores of the Self-care of Heart Failure Index (SCHFI) between baseline and 6months after the introduction of application-based HF self-care.
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
Patients who fulfilled all the criteria were considered eligible:
1) Adult patients who regularly visit to the outpatient department of Cardiology in Chiba University hospital.
2) Patients who had been maintaining self-care by using a notebook in which vital signs, heart failure-related symptoms, and/or drug adherence were recorded daily.
3) Patients who can manipulate the Omron device HCR-7800T, a manometer and a simple electrocardiogram with IoT function.
4) Patients who can manipulate the self-care application on the smartphone or tablet device.
5) Patients who can adequately communicate in Japanese.
Key exclusion criteria
Patients were excluded if they were
1) In Stage D heart failure or end-stage heart failure
2) Unable to regularly visit to the clinic
3) Unable to maintain self-care due to cognitive or mental disorders
4) expected to survive less than 1 year
5) unwilling to join the study
6) considered ineligible by the principal or collaborative investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Okada |
Organization
Chiba university Graduate School of Medicine
Division name
Cardiovascular Medicine
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba
TEL
043-226-2555
shookada-circ@umin.ac.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Okada |
Organization
Chiba university Graduate School of Medicine
Division name
Cardiovascular Medicine
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba
TEL
043-226-2555
Homepage URL
shookada-circ@umin.ac.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
self-funded; OMRON Healthcare Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital Clinical study Clinical Research Ethics Review Committee
Address
1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba
Tel
043-222-7171
prc-jim@chiba-u.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 | 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
20
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
| 2022 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Change in the European Heart Failure Self-Care Scale after 6 months of use
2) Increase in the percentage of patients with good self-care on the Heart Failure Self-Care Index after 6 months of use
3) Change in BNP or NT-proBNP levels after 6 months of use
4) Change in NYHA functional class at 6 months
5) Correlation between change in BNP or NT-proBNP and each questionnaire score
6) Exacerbation of heart failure (increase in diuretic dose or hospitalization due to heart failure)
7) Continued use of the application during the first 1-2 months of use
8) Changes in blood pressure or weight measurements per month before and after the start of the application
9) Number of times the app is used per month
Management information
Registered date
| 2022 | Year | 05 | Month | 08 | Day |
Last modified on
| 2023 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054360
