UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056572 |
|---|---|
| Receipt number | R000054916 |
| Scientific Title | Verification of the effectiveness of the Lifestyle Improvement Program through Tablets for the elderly living in the community Crossover randomized controlled trial |
| Date of disclosure of the study information | 2024/12/27 |
| Last modified on | 2024/12/26 09:46:06 |
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Basic information
Public title
Verification of the effectiveness of the Lifestyle Improvement Program through Tablets for the elderly living in the community Crossover randomized controlled trial
Acronym
Verification of the effectiveness of the Lifestyle Improvement Program through Tablets for the elderly living in the community Crossover randomized controlled trial
Scientific Title
Verification of the effectiveness of the Lifestyle Improvement Program through Tablets for the elderly living in the community Crossover randomized controlled trial
Scientific Title:Acronym
Verification of the effectiveness of the Lifestyle Improvement Program through Tablets for the elderly living in the community Crossover randomized controlled trial
Region
| Japan |
Condition
Condition
No disease
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to conduct a crossover randomized controlled trial in which community-dwelling elderly persons aged 65 years or older were randomly assigned to two groups, one group was given a program to support social participation using ICT equipment and the other group was given a program to improve physical and mental functions focusing on the locomotor system. The purpose of the study was to determine whether changes in lifestyle function, quality of life (QOL), and social participation could be expected.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
WHO/QOL26
Checklist for Preventing Caregiving
Physical Function
Key secondary outcomes
FAI self-assessment chart
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Each session of the experimental group program will have a theme related to ICT and will consist of two parts: a "lecture" and an "exercise. In the "Lecture," participants will reflect on their lives and daily routines, and learn how ICT devices can expand the range of their lives and how they can be used. In the "Exercises," participants will practice tasks using ICT devices (sending e-mails, watching videos, etc.) that they can apply in their daily lives in cooperation with other participants so that they can use the devices in their actual lives.
The program, which lasts about 80 minutes per session, will be held a total of 8 times over a period of about 4 months.
Interventions/Control_2
The control group's program consisted mainly of practical skills for improving motor unit functions and preventing cognitive decline, based on the manual for preventing nursing care provided by the Ministry of Health, Labour and Welfare.
The first half of the program consists of a "lecture" on health, and the second half is an "exercise" program of actual physical activity. The first half of the program consists of a "lecture" on health, and the second half consists of an "exercise" program for actual physical activity.
The program, which lasts about 80 minutes per session, will be held a total of eight times over a period of about four months.
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
Those who are 65 years of age or older and not certified as requiring nursing care 1 or higher.
Able to come to the program site unassisted or accompanied by a family member.
People 65 years of age or older living in the area who meet the above two criteria.
Key exclusion criteria
Those who cannot come to the venue where the program is conducted
Those who cannot understand the content of the research
Those who cannot show their willingness to cooperate in the research
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Kawabata |
Organization
Tokyo Metropolitan University
Division name
Doctor Course, Department of Occupational Therapy, Graduate School of Human Health Sciences
Zip code
1160012
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
TEL
03-3819-1211
kawabata0723ot@gmail.com
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Kawabata |
Organization
Tokyo Metropolitan University
Division name
Doctor Course, Department of Occupational Therapy, Graduate School of Human Health Sciences
Zip code
1160012
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
TEL
03-3819-1211
Homepage URL
kawabata0723ot@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
None
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
Tokyo Metropolitan University
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
Tel
03-3819-1211
kawabata0723ot@gmail.com
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 | 12 | Month | 27 | 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
54
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 | 01 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 01 | 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 | 12 | Month | 26 | Day |
Last modified on
| 2024 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054916
