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 Middle name Last name Masayuki Takagi
Organization	Prefectural University of Hiroshima
Division name	Department of Occupational Therapy
Zip code
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 Middle name Last name Masayuki Takagi
Organization	Prefectural University of Hiroshima
Division name	Department of Occupational Therapy
Zip code
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
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	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
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	No longer recruiting
Date of protocol fixation	2017 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date	2018 Year 01 Month 15 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 01 Month 15 Day
Last modified on	2019 Year 08 Month 29 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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