UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050302 |
|---|---|
| Receipt number | R000057271 |
| Scientific Title | The effectiveness of smartphone training class in physical activities and social isolation of community-dwelling older adults; Randomized Controlled Trial |
| Date of disclosure of the study information | 2023/02/10 |
| Last modified on | 2024/08/12 11:39:33 |
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Basic information
Public title
The effectiveness of smartphone training class in physical activities and social isolation of community-dwelling older adults; Randomized Controlled Trial
Acronym
The effectiveness of smartphone training class in physical activities and social isolation of community-dwelling older adults; Randomized Controlled Trial
Scientific Title
The effectiveness of smartphone training class in physical activities and social isolation of community-dwelling older adults; Randomized Controlled Trial
Scientific Title:Acronym
The effectiveness of smartphone training class in physical activities and social isolation of community-dwelling older adults; Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Community-dwelling older adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identifying the effectiveness of smartphone class in physical activities and social isolation of community-dwelling older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1)Physical activities
Pre intervention and 8 weeks post intervention
Key secondary outcomes
1)Frequency of interpersonal interaction
2)Loneliness (The Three-Item Loneliness Scale; TIL-scale)
3)Frequency of using the smartphone
4)Frequency of going out
5)Sleeping time
Pre intervention and 8 weeks post intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participate in 60-minute smartphone class once a week for 8 weeks.
Interventions/Control_2
No intervention
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Men and Women over 60 years old residing in Osaka City who own a smartphone.
Key exclusion criteria
1) Persons with circulatory or respiratory diseases that limit their ability to exercise.
2) Patients who have difficulty walking independently without a caregiver.
3) Suspected general cognitive impairment with a Mini-Cog result of 2 points or less at baseline assessment.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Higuchi |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation
Zip code
583-8555
Address
3-7-30 Habikino, Habikino City, Osaka, Japan
TEL
072-950-2111
Higu_reha@omu.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Hashimoto |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation
Zip code
583-8555
Address
3-7-30 Habikino, Habikino City, Osaka, Japan
TEL
072-950-2111
Homepage URL
sf22165w@st.omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Welfair Promotion Section, Osaka Area Management Department, UR Urban Renaissance Agency West Japan Branch
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Metropolitan University
Address
3-7-30 Habikino, Habikino City, Osaka, Japan
Tel
072-950-2111
sf22165w@st.omu.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 | 02 | Month | 10 | 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
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 10 | 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 | 02 | Month | 10 | Day |
Last modified on
| 2024 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057271
