![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000030814 |
Receipt No. | 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 | 2020/07/17 |
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 |
|
Condition | ||
Condition | Well older adults | |
Classification by specialty |
|
|
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 | ||||||
takagi@pu-hiroshima.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
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 | |||||||
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 |
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 |
|
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 |
|
||||||
Results Delayed | |||||||
Results Delay Reason | |||||||
Date of the first journal publication of results |
|
||||||
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
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 |
|
||||||
Last modified on |
|
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 |