UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| 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 | 2020/10/02 (Ver. 9) |
* 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 | 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 |
|
|
| Condition | ||
| Condition | Healthy person | |
| Classification by specialty |
|
|
| 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 |
|
|
| 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 |
|
|||
| Age-upper limit |
|
|||
| 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 |
|
||||||
| 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 |
|
||||||
| 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 | |
| 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 |
| 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 |
|
||||||
| 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 |
|
||||||
| Results Delayed |
|
||||||
| Results Delay Reason | because the paper was rejected | ||||||
| Date of the first journal publication of results |
|
||||||
| 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 |
|
||||||
| Date of IRB |
|
||||||
| Anticipated trial start date |
|
||||||
| Last follow-up date |
|
||||||
| Date of closure to data entry |
|
||||||
| Date trial data considered complete |
|
||||||
| Date analysis concluded |
|
||||||
| Other | |
| Other related information | |
| Management information | |||||||
| Registered date |
|
||||||
| Last modified on |
|
||||||
| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033542 |
