UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053089 |
|---|---|
| Receipt number | R000058705 |
| Scientific Title | Effects of participation in online health program on health-related indicators |
| Date of disclosure of the study information | 2023/12/13 |
| Last modified on | 2023/12/12 12:05:03 |
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Basic information
Public title
Effects of participation in online health program on health-related indicators for the elderly
Acronym
Effects of participation in online health program on health-related indicators
Scientific Title
Effects of participation in online health program on health-related indicators
Scientific Title:Acronym
Effects of participation in online health program on health-related indicators
Region
| Japan |
Condition
Condition
Frailty
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of participating in an online health program on maintaining and improving health-related indicators, digital use, and creating connections.
To test the effectiveness of a comprehensive online health program that promotes the elimination of the digital divide and the maintenance and improvement of cognitive function, in addition to the three pillars of the Anti-Frail Measures: exercise, diet, and social participation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frailty
Key secondary outcomes
<Physical Measurement Items>
Health-related indicators
Height, body composition, physical activity, vegetable intake, brain health, emotional evaluation, autonomic balance evaluation, hemoglobin measurement evaluation, BDHQ evaluation
<ICT skill items>
Time when participants completed Zoom connection, participation in health program (number of times)
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
| Behavior,custom |
Interventions/Control_1
Intervention group
People who participate in online health program
-Physical condition check 10 minutes / Exercise 45 minutes / Dietary lecture 5 minutes / Photo sharing game about 20 minutes
-Once a week for a total of 6 sessions as a set.
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
| 84 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults aged 65-84 years old living in Chofu City, Tokyo.
Key exclusion criteria
Certified as requiring assistance or nursing care.
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Ohkawara |
Organization
The University of Electro-Communications
Division name
Graduate School of Informatics and Engineering
Zip code
1828585
Address
1-5-1 Chofugaoka, Chofu, Tokyo, 182-8585, Japan
TEL
042-443-5584
ohkawara_kazunori@e-one.uec.ac.jp
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | |
| Last name | Ohkawara |
Organization
The University of Electro-Communications
Division name
Graduate School of Informatics and Engineering
Zip code
1828585
Address
1-5-1 Chofugaoka, Chofu, Tokyo, 182-8585, Japan
TEL
042-443-5584
Homepage URL
ohkawara_kazunori@e-one.uec.ac.jp
Sponsor or person
Institute
The University of Electro-Communications
Institute
Department
Personal name
Funding Source
Organization
Chofu city, Tokyo
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Labor and safty office, Personnel and labor affairs office, The University of Electro-Communications
Address
1-5-1 Chofugaoka, Chofu, Tokyo, 182-8585, Japan
Tel
042-443-5028
human-ethics@office.uec.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
| 2023 | Year | 12 | Month | 13 | 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
145
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | 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 | 12 | Month | 13 | Day |
Last modified on
| 2023 | 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=R000058705
