UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037384 |
|---|---|
| Receipt number | R000042616 |
| Scientific Title | Study on effectiveness of multiple education / practice programs for community-dwelling older adults |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2022/07/19 10:18:11 |
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Basic information
Public title
Study on effectiveness of multiple education / practice programs for community-dwelling older adults
Acronym
Effectiveness of multiple intervention programs for community-dwelling older adults
Scientific Title
Study on effectiveness of multiple education / practice programs for community-dwelling older adults
Scientific Title:Acronym
Effectiveness of multiple intervention programs for community-dwelling older adults
Region
| Japan |
Condition
Condition
Elderly individuals aged 60 years old or older
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of the multiple education / practice programs which is focused on the prevention of frailty for the physical and mental conditions of community-dwelling older adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
frailty index of before and after the intervention
Key secondary outcomes
The Activities of Daily Living(ADL),Oquality of life(QOL),the Geriatric Depression Scale(GDS-15),Apacy, health literacy Survey Questionnaire(J-HLS-EU-Q47),social network, physical functions(gait speed, balance ability, etc),cognitive functions (MMSE, MoCA-J, trail making test, etc.),and the Oral function, before and after the intervention (6-month after).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participation in the multiple education / practice programs which is focused on the prevention of frailty for 6 months
Interventions/Control_2
Live as usual for 6 months
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All elderly people living in Toyoyama-cho, over 60 years old
Those who understand the research content and obtained consent by writing
Key exclusion criteria
Individuals who do not have enough ability to fully agree on research participation
Individuals who have received nursing care certification
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Kuzuya |
Organization
Nagoya University
Division name
Institute of innovation for future society (Department of community health & geriatrics graduate school of medicine)
Zip code
4668550
Address
65 Tsurumai-cyo, Showa-ku, Nagoya, 466-8550, Japan
TEL
+81527442368
aiaiori@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Aiko |
| Middle name | |
| Last name | Inoue |
Organization
Nagoya University
Division name
Institute of innovation for future society (Department of community health & geriatrics graduate sch
Zip code
466-8550
Address
65 Tsurumai-cyo, Showa-ku, Nagoya, 466-8550, Japan
TEL
052-744-2364
Homepage URL
aiaiori@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Japan science and technology agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Toyoyama-cho, Nishikasugai-gun, Aichi prefecture, Japan
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University
Address
65 Tsurumai-cyo, Showa-ku, Nagoya, 466-8550, Japan
Tel
052-744-2368
aiaiori@med.nagoya-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
| 2019 | Year | 09 | Month | 01 | 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
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 16 | Day |
Last modified on
| 2022 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042616
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
