UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000036900
Receipt No. 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 (Ver. 4)

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

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
Email 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
Email kawabata0723ot@gmail.com

Sponsor
Institute Tokyo Metropolitan University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042036