UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055240 |
|---|---|
| Receipt number | R000063115 |
| Scientific Title | Study on Changes in Heart Rate Variability Indicators Estimated from Ballistocardiography in Terminally Ill Elderly Patients |
| Date of disclosure of the study information | 2024/08/31 |
| Last modified on | 2024/08/14 13:15:39 |
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Basic information
Public title
Study on Changes in Heart Rate Variability Indicators Estimated from Ballistocardiography in Terminally Ill Elderly Patients
Acronym
Study on Changes in Heart Rate Variability Indicators Estimated from Ballistocardiography in Terminally Ill Elderly Patients
Scientific Title
Study on Changes in Heart Rate Variability Indicators Estimated from Ballistocardiography in Terminally Ill Elderly Patients
Scientific Title:Acronym
Study on Changes in Heart Rate Variability Indicators Estimated from Ballistocardiography in Terminally Ill Elderly Patients
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By prospectively observing changes in heart rate variability indicators calculated from BCG in terminally ill elderly patients, we aim to predict the patient's condition and the timing of end-of-life care.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In-hospital events (death, deterioration)
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Patients aged 65 or older at the time of obtaining consent
2 Bedridden terminally ill elderly patients receiving care
Key exclusion criteria
1 Patients with severe organ failure
2 Patients with an implanted pacemaker
3 Patients with chronic atrial fibrillation or frequent premature contractions
4 Patients taking medications that affect heart rate variability (e.g., beta-blockers)
5 Cancer patients
6 Other patients deemed unsuitable for the study by the principal investigator
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Naotake |
| Middle name | |
| Last name | Yanagisawa |
Organization
Juntendo University
Division name
Medical Technology Innovation Center
Zip code
113-8421
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL
03-3830-3704
n-yanagisawa@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Naotake |
| Middle name | |
| Last name | Yanagisawa |
Organization
Juntendo University
Division name
Medical Technology Innovation Center
Zip code
113-8421
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL
03-3830-3704
Homepage URL
n-yanagisawa@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
hongo-rinri@juntendo.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
| 2024 | Year | 08 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study targeting terminally ill elderly residents in nursing care facilities. It aims to observe heart rate variability indicators and investigate the association between these indicators and the occurrence of events.
Management information
Registered date
| 2024 | Year | 08 | Month | 14 | Day |
Last modified on
| 2024 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063115
