UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034743
Receipt No. R000039609
Official scientific title of the study 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 2018/11/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study The effectiveness of the Occupational Management Program for community-dwelling older adults using the Activity Diary
Title of the study (Brief title) 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, The Social Activities-Related Daily Life Satisfaction Scale, and an original questionnaire based on the Canadian Occupational Performance Measure (the questionnaire for important occupation) are used to measure satisfaction with daily occupation.
Key secondary outcomes Life satisfaction, the feeling that life is worth and subjective health 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. SF-12 is used to measure the subjective health.

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 Masayuki Takagi
Organization Prefectural University of Hiroshima
Division name Department of Occupational Therapy
Address 1-1 Gakuen-Cho Mihara
TEL 0848-60-1197
Email takagi@pu-hiroshima.ac.jp

Public contact
Name of contact person Masayuki Takagi
Organization Prefectural University of Hiroshima
Division name Department of Occupational Therapy
Address 1-1 Gakuen-Cho Mihara
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
Name of secondary funder(s)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 10 Month 30 Day
Anticipated trial start date
2019 Year 01 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 01 Day
Last modified on
2018 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_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


Contact us.