UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051144 |
|---|---|
| Receipt number | R000058327 |
| Scientific Title | Study on providing cardiovascular disease prevention services using telemonitoring with IoT medical devices |
| Date of disclosure of the study information | 2023/05/23 |
| Last modified on | 2023/11/22 10:15:39 |
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Basic information
Public title
Study on providing cardiovascular disease prevention services using telemonitoring with IoT medical devices
Acronym
Study on providing cardiovascular disease prevention services using telemonitoring with IoT medical devices
Scientific Title
Study on providing cardiovascular disease prevention services using telemonitoring with IoT medical devices
Scientific Title:Acronym
Study on providing cardiovascular disease prevention services using telemonitoring with IoT medical devices
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether cardiovascular disease prevention services using telemonitoring with IoT medical devices at home can prevent readmission of heart failure patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of days until readmission due to heart failure
Key secondary outcomes
Blood pressure, Heart rate, Body weight, Body temperature, Oxygen saturation
Blood test: Total protein, Albumin, Blood neutral fat (TG), HDL-cholesterol, LDL-cholesterol, AST(GOT), ALT(GPT), ALP, gamma -GTP, CPK, Total bilirubin, Uric acid, Urea nitrogen, Creatinine, eGFR, Sodium, Potassium, Chlorine, TSH, fT4, fT3, BNP, Blood glucose
Urine test: General urine (Protein qualitative, Glucose qualitative, Occult blood qualitative, Protein quantitative, Creatinine quantitative, Na, K quantitative)
Subjective findings (Heart failure pocket book)
Objective findings (medical interview, etc.)
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
To monitor the measurements taken by blood pressure monitors, weight scales, thermometers, and pulse oximeters for up to one year, and provide online medical consultations or instructions from a doctor via online diagnosis to patients who have issues.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2. Japanese men and women aged 20 years or older at the time of obtaining consent
3. Persons who have been hospitalized due to heart failure
Key exclusion criteria
1. Persons who cannot properly perform self-measurement using blood pressure monitors, weight scales, thermometers, and pulse oximeters
2. Persons who were judged as inappropriate for study participants by the attending physician and the principal investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Yatabe |
Organization
General Incorporated Association
telemedEASE
Division name
Representative Director
Zip code
102-0083
Address
2F Kojimachi New Yahiko Building, 2-30, Kojimachi 6-chome, Chiyoda-ku, Tokyo
TEL
050-3528-8454
support@telemedease.org
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Yatabe |
Organization
General Incorporated Association telemedEASE
Division name
Representative Director
Zip code
102-0083
Address
2F Kojimachi New Yahiko Building, 2-30, Kojimachi 6-chome, Chiyoda-ku, Tokyo
TEL
050-3528-8454
Homepage URL
support@telemedease.org
Sponsor or person
Institute
General Incorporated Association
telemedEASE
Institute
Department
Personal name
Funding Source
Organization
Tateisi Science and Technology Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
TAKEDA GENERAL HOSPITAL
University of Aizu
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel
052-734-8885
soumu@hc-sys.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
| 2023 | Year | 05 | Month | 23 | 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
| 2023 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 05 | Month | 23 | Day |
Last modified on
| 2023 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058327
