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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033573
Receipt No. R000038272
Official scientific title of the study Inquiry into the effects of undertaking programs aimed at mental, psychological, and social aspects in a preventive care
Date of disclosure of the study information 2018/08/03
Last modified on 2018/07/31

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Basic information
Official scientific title of the study Inquiry into the effects of undertaking programs aimed at mental, psychological, and social aspects in a preventive care
Title of the study (Brief title) Inquiry into the effects of undertaking programs aimed at mental, psychological, and social aspects in a preventive care
Region
Japan

Condition
Condition People who live in community
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To inquire into the effects of undertaking groupwork activities aimed at mental, psychological, and social aspects in a preventive care program
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Activities of daily living and occupational functions
Key secondary outcomes Cognitive functions, automatic thoughts, and physical functions

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom Other
Interventions/Control_1 Participants engaged in exercises and lectures about improving their nutritional condition and preventing diseases, for 60-90 minutes, and groupwork activities aimed at mental, psychological, and social aspects for 30-60 minutes.
Programs are carried out for about two hours each time, about 12 times, and for three months.
Interventions/Control_2 Participants engaged in exercises and lectures about improving their nutritional condition and preventing diseases, for 60-90 minutes, and games and chatting and so on for 30-60 minutes.
Programs are carried out for about two hours each time, about 12 times, and for three months.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Persons who participate in this program by getting to know about it through circular notices, leaflets, and bulletin boards in Atsubetsu-ku in Sapporo city, and agree with taking part in this study.
Key exclusion criteria Not applicable
Target sample size 50

Research contact person
Name of lead principal investigator Risa Takashima
Organization Hokkaido University
Division name Faculty of Health Sciences, Department of Functioning and Disability
Address Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-0812, Japan
TEL 011-706-3380
Email risa-t@hs.hokudai.ac.jp

Public contact
Name of contact person Risa Takashima
Organization Hokkaido University
Division name Faculty of Health Sciences, Department of Functioning and Disability
Address Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-0812, Japan
TEL 011-706-3380
Homepage URL
Email risa-t@hs.hokudai.ac.jp

Sponsor
Institute Faculty of Health Sciences, Department of Functioning and Disability, Hokkaido 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)

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
2018 Year 08 Month 03 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 08 Month 03 Day
Anticipated trial start date
2018 Year 08 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 31 Day
Last modified on
2018 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038272

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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