UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039689 |
|---|---|
| Receipt number | R000045267 |
| Scientific Title | Intervention effects of support to enhance achievement motive for care prevention of healthy elderly: Preliminary study of before-after trial among regional salon participants |
| Date of disclosure of the study information | 2020/03/04 |
| Last modified on | 2024/03/07 09:39:41 |
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Basic information
Public title
Intervention effects of support to enhance achievement motive for care prevention of healthy elderly: Preliminary study of before-after trial among regional salon participants
Acronym
Preliminary study of support to enhance achievement motive for healthy elderly
Scientific Title
Intervention effects of support to enhance achievement motive for care prevention of healthy elderly: Preliminary study of before-after trial among regional salon participants
Scientific Title:Acronym
Preliminary study of support to enhance achievement motive for healthy elderly
Region
| Japan |
Condition
Condition
Healthy elderly
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the effect on improvement of daily activities and frail symptoms for community-dwelling elderly by assessing the state of achievement motive and by intervention based on self-regulated learning to enhance them.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Daily activities (using activity monitoring devices and index of activities of daily living)
Key secondary outcomes
Muscle mass using body composition analyzer, Physical functions (grip strength, short physical performance battery), Scale for achievement motive in geriatrics, Comprehensive environment questionnaire, number of role expectation
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Comparison of the baseline phase (before the intervention) and the phase of immediately after the intervention (for about 6 months) by the support to encourage setting and carry through goals.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Elderly people living in Fukuoka City who are 65 years or older and have signed the consent to participate in the study
Key exclusion criteria
Persons with symptoms such as dementia or mental illness (schizophrenia, etc.)
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Sano |
Organization
Fukuoka International University of Health and Welfare
Division name
Department of Occupational Therapy
Zip code
8140001
Address
3-6-40, Momochihama, Sawara Ward, Fukuoka City, Fukuoka Prefecture
TEL
092-832-1200
sano@takagigakuen.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Sano |
Organization
Fukuoka International University of Health and Welfare
Division name
Department of Occupational Therapy
Zip code
814001
Address
3-6-40, Momochihama, Sawara Ward, Fukuoka City, Fukuoka Prefecture
TEL
092-832-1200
Homepage URL
sano@takagigakuen.ac.jp
Sponsor or person
Institute
Fukuoka International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
No fund
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka International University of Health and Welfare
Address
3-6-40, Momochihama, Sawara Ward, Fukuoka City, Fukuoka Prefecture
Tel
092-832-1200
fiuhw-rinri@takagigakuen.ac.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
| 2020 | Year | 03 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
0
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2020 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Due to the effects of COVID-19, it became difficult to participate in the study population, which led to the cancellation of the study.
Management information
Registered date
| 2020 | Year | 03 | Month | 04 | Day |
Last modified on
| 2024 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045267
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
