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Name:
UMIN ID:

Recruitment status Completed
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 2021/01/10

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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 Risa
Middle name
Last name Takashima
Organization Hokkaido University
Division name Faculty of Health Sciences, Department of Functioning and Disability
Zip code 060-0812
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 Risa
Middle name
Last name Takashima
Organization Hokkaido University
Division name Faculty of Health Sciences, Department of Functioning and Disability
Zip code 060-0812
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 Expert committee of the Faculty of Health Sciences of Hokkaido University
Address Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-0812, Japan
Tel 011-706-3316
Email shomu@hs.hokudai.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 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 https://doi.org/10.1080/11038128.2020.1849395
Publication of results Published

Result
URL related to results and publications https://doi.org/10.1080/11038128.2020.1849395
Number of participants that the trial has enrolled 22
Results This study developed Colour Narrative and quantitatively and qualitatively explored its effects.
As a result, the harsh living conditions due to heavy snowfall reduced the participants' overall activity. In this environment, Colour Narrative encouraged them to control their lives more in their own ways and enhanced their HRQOL. The core of their experiences was
'negating occupations'. This negotiation was a highly intellectual task that significantly improved their cognitive function.
Results date posted
2021 Year 01 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Mean age (age(SD)): 74.9(6.1).
Gender(n(%)) Man/Woman: 2 (12.5)/14 (87.5).
Family structure (n(%)) single-living/living together: 5 (31.3)/11 (68.7).
Cognitive function: According to the results of the Mini-Mental State Examination-Japanese, 7 participants had a score of 28 or more (normal level), 8 participants had a score of 24-27 (mild cognitive impairment level), and 1 participant had a score of 23 or less (suspected dementia level).
Participant flow A total of 22 older adults participated in the intervention program.
Two participants who used long-term care services dropped out due to poor physical condition. Two of the participants refused quantitative assessments, and two others were absent from the post-intervention assessments.
Therefore, the results of 16 participants were valid for quantitative data analysis and 20 for qualitative data analysis.
Adverse events None
Outcome measures Cognitive functions: Trail Making Test (Part A), Standard verbal paired-associate learning test, Mini-Mental State Examination-Japanese.

Depressive symptoms: Geriatric Depression Scale-15

Exercise habits: Transtheoretical model

Instrumental activities of daily living: Frenchay Activities Index

Participation status of valuable occupations: Self-completed Occupational Performance Index

Health-related quality of life: World Health Organization Quality of Life 26

Process of the Colour Narrative: Qualitative interviews
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 07 Month 02 Day
Date of IRB
2018 Year 07 Month 17 Day
Anticipated trial start date
2018 Year 07 Month 02 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
2018 Year 07 Month 02 Day
Last modified on
2021 Year 01 Month 10 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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