UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046360 |
|---|---|
| Receipt number | R000052898 |
| Scientific Title | Palliative care research using wearable devices and the Internet of Things |
| Date of disclosure of the study information | 2021/12/12 |
| Last modified on | 2021/12/12 18:05:54 |
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Basic information
Public title
Palliative care research using wearable devices and the Internet of Things
Acronym
Palliative care research using wearable devices and the Internet of Things
Scientific Title
Palliative care research using wearable devices and the Internet of Things
Scientific Title:Acronym
Palliative care research using wearable devices and the Internet of Things
Region
| Japan |
Condition
Condition
all disease
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will use wearable devices and the Internet of Things (IOT) to assess physical pain, such as pain and dyspnea, as well as blood pressure and pulse rate fluctuations to provide early symptom relief and improve the quality of palliative care.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessing changes in the patient during changes in blood pressure and pulse rate
Key secondary outcomes
Palliative care quality assessment after research intervention
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients were aware of pain when evaluated with the Numerical Rating Scale (NRS), Visual Analogue Scale (VAS), Verbal Rating Scale (VRS), and Faces Pain Scale (FPS) at rest.
Key exclusion criteria
Cases in which the patient is unable to give consent or the physician deems it inappropriate.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takehito |
| Middle name | |
| Last name | Kobayashi |
Organization
Saitama Medical University
Division name
Department of General Medicine
Zip code
3500495
Address
38, Morohongo, Moroyama-machi, Iruma-gun, Saitama Pref.
TEL
0492761319
jaczikk1025@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takatoshi |
| Middle name | |
| Last name | Uno |
Organization
Saitama Medical University
Division name
Department of General Medicine
Zip code
3500495
Address
38, Morohongo, Moroyama-machi, Iruma-gun, Saitama Pref.
TEL
0492761319
Homepage URL
jaczikk1025@yahoo.co.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University
Address
38, Morohongo, Moroyama-machi, Iruma-gun, Saitama Pref.
Tel
0492761319
tuno@saitama-med.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
| 2021 | Year | 12 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 12 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2021 | Year | 12 | Month | 12 | Day |
Last modified on
| 2021 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052898
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
