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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033246
Receipt No. R000037905
Scientific Title Developing a program for a more active senior life in Iwamizawa City
Date of disclosure of the study information 2018/07/02
Last modified on 2018/07/02

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Basic information
Public title Developing a program for a more active senior life in Iwamizawa City
Acronym Developing a program for a more active senior life
Scientific Title Developing a program for a more active senior life in Iwamizawa City
Scientific Title:Acronym Developing a program for a more active senior life
Region
Japan

Condition
Condition Healthy aged people or aged people with mild frailty who live in community
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To subjectively and objectively explore the effects brought by a program for a more active senior life for aged people living in community.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Subjective sense of well-being, quality of life, and degree of autonomy and satisfaction of life (occupations)
Key secondary outcomes Health condition, depressive state, cognitive functions, and visual function

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 Prevention
Type of intervention
Behavior,custom Other
Interventions/Control_1 "Intervention 1: Reflecting on one' s life".
Participants engage in the group work using "Iro-karuta", which is a traditional Japanese card game consisted by 128 colored cards.
"Intervention 2: Practice to slightly improve life in near feature".
First, participants identify important occupations to improve their lives in near feature. Then, they make a plan to perform the occupations. After that, they practice the plan in their daily lives for a few months.
"Intervention 3: Reflecting on practice".
Participants engage in the group work to reflect on their practices of the Interventions 2 with each other.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Members of an activity group of autonomous aged people in Iwamizawa City in Hokkaido who agree with participating in this research.
Key exclusion criteria To score less than 15 in the Mini Mental State Examination (MMSE).
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Risa Takashima
Organization Hokkaido University
Division name Faculty of Health Sciences, Department of Functioning and Disability
Zip code
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
1st name
Middle name
Last name Risa Takashima
Organization Hokkaido University
Division name Faculty of Health Sciences, Department of Functioning and Disability
Zip code
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 "Innovative Food & Healthcare MASTER" of the Center of Innovation (COI) STREAM
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 岩見沢市日の出南会館(北海道)/ Iwamizawa-shi Hinode Minami Kaikan (Hokkaido)

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 02 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 Preinitiation
Date of protocol fixation
2018 Year 07 Month 02 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 02 Day
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
2018 Year 07 Month 02 Day
Last modified on
2018 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037905

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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