UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036900 |
|---|---|
| Receipt number | R000042036 |
| Scientific Title | Pilot study on development of social participation support program that relates life and ICT for elderly people living in the community |
| Date of disclosure of the study information | 2019/05/30 |
| Last modified on | 2020/06/08 15:33:16 |
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Basic information
Public title
Pilot study on development of social participation support program that relates life and ICT for elderly people living in the community
Acronym
Pilot study on development of ICT program for elderly people living in the community
Scientific Title
Pilot study on development of social participation support program that relates life and ICT for elderly people living in the community
Scientific Title:Acronym
Pilot study on development of ICT program for elderly people living in the community
Region
| Japan |
Condition
Condition
Geriatrics
Psychiatry
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is to verify the program's effectiveness which are like the use situation of ICT equipment and operation skill level, health related QOL, social life skills. The program is a group program will be implemented about 80 minutes for a total of eight times, which will help participants to improve their own health through ICT equipment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire about use of ICT equipment
WHO/QOL26
Key secondary outcomes
Frenchay Activities Index
JST agency index to assess functional capacity
OSA ver.2.1
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Programs focusing on health promotion with using ICT equipment
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) The comprehensive daily living support elderly over 65 years old
2) Those who can come to the program implementation site on their own or can attend family attendance
Key exclusion criteria
1) Those who can not visit the program
2) Those who can not understand the contents of reserch
3) Those who can not show their intension to cooperate on their own
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Kawabata |
Organization
Tokyo Metropolitan University
Division name
Master 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
Master 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
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metroporitan 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
| 2019 | Year | 05 | Month | 30 | 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
34
Results
The significant differences in the amount of change were found in the following items: understanding of the questionnaire on the use of ICT devices, interest All items of frequency of use, importance, level of performance, satisfaction, use of new equipment in JST, life management The following items are included in this category: the items of the OSA on willpower and ability to perform, the psychological domain in WHO-QOL26, the environment area and FAI, all of which were higher after the intervention.
Results date posted
| 2020 | Year | 06 | Month | 08 | Day |
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
| 2019 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 30 | Day |
Last modified on
| 2020 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042036
