UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030814
Receipt number 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 2023/04/17 18:55:15

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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 or person

Institute

Prefectural University of Hiroshima

Institute

Department

Personal name



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

2023 Year 04 Month 17 Day



Link to view the page

Value
https://center6.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