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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029350
Receipt No. R000033542
Scientific Title Feasibility of community residents' health promotion support program using cognitive behavioral therapy approach via information and communication technology (ICT)
Date of disclosure of the study information 2017/10/01
Last modified on 2019/04/01

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Basic information
Public title Feasibility of community residents' health promotion support program using cognitive behavioral therapy approach via information and communication technology (ICT)
Acronym Development of community residents' health promotion support program using of CBT approach
Scientific Title Feasibility of community residents' health promotion support program using cognitive behavioral therapy approach via information and communication technology (ICT)
Scientific Title:Acronym Development of community residents' health promotion support program using of CBT approach
Region
Japan

Condition
Condition Healthy person
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 we conduct intervention by the health promotion support program based on the theory and skill of cognitive behavioral therapy via ICT and examine feasibility of it
Basic objectives2 Others
Basic objectives -Others Ask elderly people to use a health promotion program based on CBT through smart devices such as robots, tablets, smart phones, etc. to evaluate mental health and program feeling before and after use, and obtain suggestions.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes positive emotion (Environmental Reward Observation Scale)
Key secondary outcomes

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 to enter the activity content and mood of the day in the smart device and read the column on health delivered by the smart device
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
60 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Live or work in Kesennuma-shi, Miyagi prefecture
2. Living alone
3. Work and community activities are less than 30 hours a week
4. Have experience using smartphones, tablets, personal computers and operation is not difficult
5. Japanese is the mother tongue
6. Understand the purpose and contents of this research, and obtain the consent of necessary research participation from the principal in writing
Key exclusion criteria 1. Currently being treated for mental illness
2. Remarkable suicidal thought
3. Substance use disorders such as alcohol dependence
4. Intellectual disability
5. Organic brain injury
6. Understanding Japanese is difficult
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Kazunori
Middle name
Last name Matsumoto
Organization Tohoku University Graduate School of Medicine
Division name Department of Psychiatry
Zip code 9808574
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL 022-717-8059
Email kaz-mat@umin.net

Public contact
Name of contact person
1st name Kazunori
Middle name
Last name Kazunori Matsumoto
Organization Tohoku University Graduate School of Medicine
Division name Department of Psychiatry
Zip code 9808574
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL 022-717-8059
Homepage URL
Email kaz-mat@umin.net

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization NEC Solution Innovators, Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee Tohoku University Graduate School of Medicine
Address 2-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
Tel 022-717-8007
Email med-kenkyo@grp.tohoku.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
2017 Year 10 Month 01 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 No longer recruiting
Date of protocol fixation
2017 Year 09 Month 27 Day
Date of IRB
2018 Year 09 Month 05 Day
Anticipated trial start date
2018 Year 09 Month 05 Day
Last follow-up date
2019 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
2017 Year 09 Month 29 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033542

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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