UMIN-CTR 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
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
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
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/ctr_e/ctr_view.cgi?recptno=R000039609
