UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000034743
Receipt number R000039609
Scientific Title The effectiveness of the Occupational Management Program for community-dwelling older adults using the Activity Diary
Date of disclosure of the study information 2018/11/09
Last modified on 2023/04/17 19:00:49

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Basic information

Public title

The effectiveness of the Occupational Management Program for community-dwelling older adults using the Activity Diary

Acronym

The effectiveness of the Occupational Management Program

Scientific Title

The effectiveness of the Occupational Management Program for community-dwelling older adults using the Activity Diary

Scientific Title:Acronym

The effectiveness of the Occupational Management Program

Region

Japan


Condition

Condition

community-dwelling older adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the effectiveness on daily occupation, life satisfaction, the feeling that life is worth and subjective health of the Occupational Management Program for community-dwelling older adults using the Activity Diary

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The evaluation is implemented at baseline, at the end and at the three month follow-up of the program.
Satisfaction of daily occupation is primary outcome. The Activity and Daily Life Satisfaction Scale is used to measure satisfaction with daily occupation.

Key secondary outcomes

Life satisfaction and the feeling that life is worth are measured as key secondary outcomes.
The Life Satisfaction Inventory- Z (LSI-Z) is used to measure life satisfaction. The K- I Scale for the Feeling that Life is Worth (K-I Scale) is used to measure the feeling that life is worth.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

The program is constructed from 4 times session for 120 minute per week. Each session is constructed from a lecture of occupation and group discussion of reflection on and planning of their daily occupations. Participants repeated planning, doing, checking, and acting cycle of their occupation using the Activity Diary in the program.

Interventions/Control_2

No intervention

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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The participants of the program are community-dwelling older adults who are over 65 years old and are independent in ADL.

Key exclusion criteria

None

Target sample size

100


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

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

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


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Prefectural University of Hiroshima

Address

1-1 Gakuen machi

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



Other administrative information

Date of disclosure of the study information

2018 Year 11 Month 09 Day


Related information

URL releasing protocol

https://www.jstage.jst.go.jp/article/jotr/39/3/39_301/_pdf/-char/ja

Publication of results

Partially published


Result

URL related to results and publications

https://www.jstage.jst.go.jp/article/jotr/39/3/39_301/_pdf/-char/ja

Number of participants that the trial has enrolled

144

Results

At the end of the program, the change scores of the intervention group improved significantly more than the control group for the ADLSS, K-I scale and LSI-Z (P<.001). The effect sizes r for each outcomes were medium (r=0.33-0.38).
On all scales, the scores 3 months after the end of the program were significantly higher than at the start of the intervention. Continued use of the activity diary was selected as a factor influencing changes in satisfaction with occupation after the program was completed.

Results date posted

2020 Year 11 Month 02 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The average age (SD) of the participants was 73 years, and the proportion of women was 70%.

Participant flow

Of the 144 participants, 125 were assigned to the experimental group and the control group. Of the 62 participants in the experimental group, 59 participants were able to re-evaluate. Of the 63 participants in the control group, 62 participants were able to re-evaluate. All 125 participants were analyzed using ITT analysis. Of the 144 participants, 137 participants completed the evaluation 3 months after the end of the program.

Adverse events

None

Outcome measures

The primary outcome was the Activity and Daily Life Satisfaction Scale (ADLSS) to measure satisfaction with occupations. The secondary outcomes were K-I Scale for the Feeling that Life is Worth Living among the Aged (K-I Scale) to measure the feeling of Ikigai and Life Satisfaction Index-Z (LSI-Z) to measure life satisfaction.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 10 Month 30 Day

Date of IRB

2018 Year 11 Month 28 Day

Anticipated trial start date

2019 Year 01 Month 09 Day

Last follow-up date

2019 Year 06 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 11 Month 01 Day

Last modified on

2023 Year 04 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039609


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name