UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054661 |
|---|---|
| Receipt number | R000059509 |
| Scientific Title | Intervention studies to test the effectiveness of health support bubbles. |
| Date of disclosure of the study information | 2024/06/14 |
| Last modified on | 2024/06/14 10:48:36 |
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Basic information
Public title
Intervention studies to test the effectiveness of health support bubbles.
Acronym
The test the effectiveness of health support bubbles.
Scientific Title
Intervention studies to test the effectiveness of health support bubbles.
Scientific Title:Acronym
The test the effectiveness of health support bubbles.
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Conduct intervention studies using health management apps and examine measures for early detection and intervention of frailty and pre-frailty.
Basic objectives2
Others
Basic objectives -Others
Examine the effectiveness of the 'health support bubble' as a new mechanism for family support for the effects of using ICT to improve health self-monitoring capacity.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
social isolation, frailty, pre-frailty
Key secondary outcomes
Weight, blood pressure, muscle mass, body fat, heart rate, number of steps, health score, breakfast, lunch, dinner, subjective mood, time of falling asleep, time of waking, sleeping time, type of exercise, duration of exercise.
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Family support
Interventions/Control_2
No family support
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Men and women currently aged 40 and over.
Must have and be able to use a smartphone.
Must have a family member (whether living with or living separately).
Must be able to install and use the health management application specified in this study.
Those who, after having been fully informed about the study and having fully understood it, are able to give their consent of their own free will in writing or via the web.
Key exclusion criteria
You plan to have a family member use the health management app within the next year
Your family (regardless of whether they live with or apart from you) do not have a smartphone, or have one but for some reason are unable to use the health management app.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Chisato |
| Middle name | |
| Last name | Hayashi |
Organization
University of Hyogo
Division name
Research Institute of Nursing Care for People and Community
Zip code
6620813
Address
13-71,Kitaoji-cho, Akashi, Hyogo
TEL
09069024135
chisaton2@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Chisato |
| Middle name | |
| Last name | Hayashi |
Organization
University of Hyogo
Division name
Research Institute of Nursing Care for People and Community
Zip code
6738588
Address
13-71Kitaoji-cho, Akashi, Hyogo
TEL
0789259653
Homepage URL
chisato_hayashi@cnas.u-hyogo.ac.jp
Sponsor or person
Institute
University of Hyogo
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
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
University of Hyogo
Address
13-71 Kitaoji-cho, Akashi, Hyogo
Tel
0789259653
chisato_hayashi@cnas.u-hyogo.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 | 06 | Month | 14 | Day |
Related information
URL releasing protocol
https://calomama.com/news_topics/571/
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
151
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
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 07 | 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
Management information
Registered date
| 2024 | Year | 06 | Month | 14 | Day |
Last modified on
| 2024 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059509
