UMIN-CTR Clinical Trial

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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