UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029350 |
|---|---|
| Receipt number | 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 | 2020/10/02 04:32:39 |
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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
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
kaz-mat@umin.net
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
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
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
10
Results
9 were treated as analysis subjects. The score totals for the EROS, GHQ-30, UCLA, PGC, SE were analyzed using Wilcoxon signed-rank test. No significant differences were found in all indexes between pre- and post-intervention. The changes in EROS showed a slight but non-significant correlation with number of inputs to the device (r=.636, p<.10). 89% subjects positively evaluated the quality of this program, and 78% subjects answered that this program was useful.
Results date posted
| 2019 | Year | 10 | Month | 03 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
because the paper was rejected
Date of the first journal publication of results
| 2020 | Year | 12 | Month | 01 | Day |
Baseline Characteristics
mean age: 69.4 years old (SD=2.6)
1 male, 8 female
Participant flow
The research participants were recruited by regional health and welfare service personnel and via public relations magazine. 3 subjects participated in the pilot trial that was conducted preliminarily before trial to detect the problems and to renovate the system. Then 10 participants recruited by regional health and welfare service personnel, via public relations magazine and newspapers joined in the definitive intervention. Out of 10 data, the 9 data were used in the analysis, and 1 participants were declined participation for reasons other than the program.
Adverse events
None
Outcome measures
1. EROS(Environmental Reward Observation Scale)
2. GHQ-30(the General Health Questionnaire-30)
3. UCLA loneliness scale (version 3)
4. revised Philadelphia Geriatric Center Moral Scale
5. self-esteem scale
6. social capital scale
7. M.I.N.I. (Mini International Neuropsychiatric Interview)
Plan to share IPD
None
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2019 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 29 | Day |
Last modified on
| 2020 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033542
