UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034698 |
|---|---|
| Receipt number | R000039556 |
| Scientific Title | Continuing participation factor and discontinuation factor for health promotion activities of the elderly |
| Date of disclosure of the study information | 2018/11/05 |
| Last modified on | 2020/04/30 12:40:41 |
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Basic information
Public title
Continuing participation factor and discontinuation factor for health promotion activities of the elderly
Acronym
Continuation / interruption factor in health promotion activities of the elderly
Scientific Title
Continuing participation factor and discontinuation factor for health promotion activities of the elderly
Scientific Title:Acronym
Continuation / interruption factor in health promotion activities of the elderly
Region
| Japan |
Condition
Condition
Frail elderly
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Participation in health promotion activities and extraction of interruption factors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function, psychological scale, semistructured interview
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Monthly health promotion activities
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elderly people without doctor's participation restrictions
Key exclusion criteria
Elderly people who can not participate due to physical fitness and medical condition
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazue |
| Middle name | |
| Last name | Sawami |
Organization
Nara Medical University
Division name
Department of Nursing
Zip code
634-8521
Address
840 Shijo, Kashihara, Nara, Japan
TEL
0744-22-3051
sawami@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazue |
| Middle name | |
| Last name | Sawami |
Organization
Nara Medical University
Division name
Department of Nursing
Zip code
634-8521
Address
840 Shijo, Kashihara, Nara, Japan
TEL
0744-22-3051
Homepage URL
sawami@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University
Address
840 Shijo, Kashihara, Nara, Japan
Tel
0744-22-3051
sawami@naramed-u.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
| 2018 | Year | 11 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
65
Results
As a result of the creative activity, it improved significantly to immediate replay memory.
The self-esteem scale, vitality and sense of accomplishment improved, but there was no significant difference.
Although stress was reduced, there was no significant difference.
Results date posted
| 2019 | Year | 10 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Elderly people living in one area
Participant flow
Performed creative activities for half a year
Adverse events
None
Outcome measures
Cognitive function
Psychological scale
Impression description
Plan to share IPD
None
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 10 | 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 | 10 | Month | 30 | Day |
Last modified on
| 2020 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039556
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
