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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030814
Receipt No. R000035176
Scientific Title Development of the program to improve the daily occupational satisfaction for community-dwelling older adults
Date of disclosure of the study information 2018/01/18
Last modified on 2020/07/17

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Basic information
Public title Development of the program to improve the daily occupational satisfaction for community-dwelling older adults
Acronym Development of the program to improve the daily occupational satisfaction
Scientific Title Development of the program to improve the daily occupational satisfaction for community-dwelling older adults
Scientific Title:Acronym Development of the program to improve the daily occupational satisfaction
Region
Japan

Condition
Condition Well older adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To pilot a group program for community-dwelling middle-aged and elderly people using the Activity Diary and to examine the effectiveness of the program
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Outcomes are measured at the start and end of the program.
Activity and Daily Life Satisfaction Scale for the Elderly
Key secondary outcomes Life Satisfaction Index Z
Scale for the Feeling that Life is Worth Living among the Aged

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
Behavior,custom
Interventions/Control_1 Participants attend the once a week for one and half hour, total 4 times group program. The program is constracted of lecture, individual work and group discassion.
Participants write the occupational diary for 3 weeks.
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
60 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria The criterias are to live in the community, be independent in daily life and not have full time job.
Key exclusion criteria Nothing
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Masayuki
Middle name
Last name Takagi
Organization Prefectural University of Hiroshima
Division name Department of Occupational Therapy
Zip code 723-0053
Address 1-1 Gakuen-cho, Mihara, Hiroshima
TEL 0848-60-1197
Email takagi@pu-hiroshima.ac.jp

Public contact
Name of contact person
1st name Masayuki
Middle name
Last name Takagi
Organization Prefectural University of Hiroshima
Division name Department of Occupational Therapy
Zip code 723-0053
Address 1-1 Gakuen-cho, Mihara, Hiroshima
TEL 0848-60-1197
Homepage URL
Email takagi@pu-hiroshima.ac.jp

Sponsor
Institute Prefectural University of Hiroshima
Institute
Department

Funding Source
Organization Mihara city
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokyo Metropolitan University
Name of secondary funder(s) Nothing

IRB Contact (For public release)
Organization Prefectural University of Hiroshima
Address 1-1 Gakuen-cho, Mihara, Hiroshima
Tel 0848-60-1120
Email health_by_doing@yahoo.co.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 県立広島大学

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 18 Day

Related information
URL releasing protocol https://www.jstage.jst.go.jp/article/jotr/39/2/39_153/_pdf/-char/ja
Publication of results Published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/jotr/39/2/39_153/_pdf/-char/ja
Number of participants that the trial has enrolled 29
Results 
The percentage of attendance was 99.1%. All participants expressed satisfaction with the program at the last session. There were statistically significant improvements of the score of satisfaction with occupations, feeling of Ikigai, and life satisfaction. Effect sizes (r) were for the ADLSS 0.50, for the K-I 0.41, and for the LSI-Z 0.50.
Results date posted
2019 Year 12 Month 12 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 04 Month 15 Day
Baseline Characteristics 
The average age (SD) was 67.4 (3.18) years. 60% of participants were women and 40% had paid jobs. More than 90% had a hobby, interacted with friends more than once a month, and drove a car.
Participant flow 
One of the 29 participants was absent from the last session and could not be evaluated at the end of the program. Furthermore, we excluded 3 patients with missing values and finally analyzed 25 patients.
Adverse events 
None
Outcome measures 
Satisfaction with occupations was measured by the Activity and Daily Life Satisfaction Scale (ADLSS). The feeling of Ikigai was measured the K-I Scale for the Feeling that Life is Worth Living among the Aged (K-I Scale).  Life satisfaction was measured by the Life Satisfaction Index-Z (LSIZ).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 11 Month 15 Day
Date of IRB
2017 Year 12 Month 05 Day
Anticipated trial start date
2018 Year 01 Month 15 Day
Last follow-up date
2018 Year 02 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2019 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 01 Month 15 Day
Last modified on
2020 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035176

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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