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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000047676
Receipt No. 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 2022/05/08

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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
Email 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
Email shookada-circ@umin.ac.jp

Sponsor
Institute Chiba University
Institute
Department

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
Email 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
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
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
2022 Year 05 Month 08 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054360

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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