UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033246 |
|---|---|
| Receipt number | 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 17:43:35 |
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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
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
risa-t@hs.hokudai.ac.jp
Sponsor or person
Institute
Faculty of Health Sciences, Department of Functioning and Disability, Hokkaido University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037905
