UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048707 |
|---|---|
| Receipt number | R000055498 |
| Scientific Title | A Prospective Observational Study Using the Application Programming Interface Calomir for Meal Image Analysis to Assess Dietary Intake in Elderly Patients with Heart Failure and Malnutrition |
| Date of disclosure of the study information | 2022/08/20 |
| Last modified on | 2023/03/09 00:31:09 |
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Basic information
Public title
A Prospective Observational Study Using the Application Programming Interface Calomir for Meal Image Analysis to Assess Dietary Intake in Elderly Patients with Heart Failure and Malnutrition
Acronym
A Prospective Observational Study Using the Application Programming Interface Calomir for Meal Image Analysis to Assess Dietary Intake in Elderly Patients with Heart Failure and Malnutrition
Scientific Title
A Prospective Observational Study Using the Application Programming Interface Calomir for Meal Image Analysis to Assess Dietary Intake in Elderly Patients with Heart Failure and Malnutrition
Scientific Title:Acronym
A Prospective Observational Study Using the Application Programming Interface Calomir for Meal Image Analysis to Assess Dietary Intake in Elderly Patients with Heart Failure and Malnutrition
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prospectively observe and investigate eating habits after discharge from the hospital using the Dietary Image Analysis API and Calomir to evaluate actual caloric intake
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nutrient content analysis results
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 65 years of age or older (regardless of gender) at the time of consent
(2) Patients with GLIM criteria or NRS-2002 more than points and evaluated as undernourished
(3) Patients who are able to take 3 regular meals orally
(4) Patients who are expected to be outpatients for at least 3 months after discharge home
(5) Patients who have a smartphone, tablet device, or other devices that can download and use the Calomir meal image analysis API
(6) Patients who have received a thorough explanation of their participation in this study, and who have given their free and voluntary written consent based on sufficient understanding
Key exclusion criteria
(1) Patients with malignant tumors (Patients who are found to have malignant tumors after participation in the study will be excluded from the analysis)
(2) Patients with diseases that affect the nutritional and metabolic pathology, such as chronic obstructive pulmonary disease, hyperthyroidism, and hypothyroidism
(3) Patients with at least one diabetic disease, hepatic disorder, or renal disorder that meets the following criteria
AST (GOT) or ALT (GPT) exceeding 2.5 times the upper limit of the facility standard
Cr exceeding 2.0 mg/dL
HbA1c (NGSP value) exceeding 8.4%
(4) Patients with a history of intestinal resection (colon polypectomy and appendicitis surgery are acceptable)
(5) Other patients deemed inappropriate by the physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuya |
| Middle name | |
| Last name | Matsue |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-0033
Address
3-3-9, Hongo, Bunkyo-Ku, Tokyo
TEL
0338133111
y-matsue@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Taishi |
| Middle name | |
| Last name | Dotare |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-0033
Address
3-3-9, Hongo, Bunkyo-Ku, Tokyo
TEL
0338133111
Homepage URL
t-dotare@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
EN Otsuka Pharmaceutical Co.
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
Research Ethics Commiittee, Faculty of Medicine, Juntendo University
Address
3-1-3, Hongo, Bunkyo-Ku, Tokyo
Tel
0358021584
hongo-rinri@juntendo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
E22-0139
Org. issuing International ID_1
Research Ethics Commiittee, Faculty of Medicine, Juntendo University
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 | 08 | Month | 20 | 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
| 2022 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 08 | Month | 20 | Day |
Last modified on
| 2023 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055498
