UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032307 |
|---|---|
| Receipt number | R000036843 |
| Scientific Title | Health promotion effect of group programs specialized in enabling life performance for the Comprehensive Daily Living Support elderly |
| Date of disclosure of the study information | 2018/04/18 |
| Last modified on | 2019/03/08 15:56:08 |
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Basic information
Public title
Health promotion effect of group programs specialized in enabling life performance for the Comprehensive Daily Living Support elderly
Acronym
Health promotion effect of group programs for the Comprehensive Daily Living Support elderly
Scientific Title
Health promotion effect of group programs specialized in enabling life performance for the Comprehensive Daily Living Support elderly
Scientific Title:Acronym
Health promotion effect of group programs for the Comprehensive Daily Living Support elderly
Region
| Japan |
Condition
Condition
Frail elderly people
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is to verify whether the improving life performance and health promotion effects can be expected, when group programs focusing on the enabling life performance are implemented for the Comprehensive Daily Living Support elderly, compared with group programs focusing on physical and mental functions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Goal Attainment Scale light
WHO/QOL26
Life Satisfaction Index
Grip strength, 5-m walking time, time and a timed up & go
Key secondary outcomes
Tokyo Metropolitan Institute of Gerontorogy Index of Competence
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Intervention group: Programs focusing on life performance (composed of two stages of learning group and group work)
Interventions/Control_2
Control group: Programs focusing on practical skills such as improving functions of exercisers prevention of cognitive deterioration
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) the Comprehensive Daily Living Support elderly from 65 to 85 years old
2) Those who can come to the program implementation site on their own or can attend family attendance
Key exclusion criteria
1) Those who can not visit the program implementation site
2) Those who can not understand the contents of the research
3) Those who can not show their intention to cooperate on their own
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichiro Furuta |
Organization
Tokyo Metroporitan University
Division name
Master Course, Department of Occupational Therapy, Graduate School of Human Health Sciences
Zip code
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
TEL
03-3819-1211
furuta-kenichiro@ed.tmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichiro Furuta |
Organization
Tokyo Metroporitan University
Division name
Master Course, Department of Occupational Therapy, Graduate School of Human Health Sciences
Zip code
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
TEL
03-3819-1211
Homepage URL
furuta-kenichiro@ed.tmu.ac.jp
Sponsor or person
Institute
Tokyo Metroporitan University
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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 | 04 | Month | 18 | 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
| 2018 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 18 | Day |
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
| 2018 | Year | 04 | Month | 18 | Day |
Last modified on
| 2019 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036843
| 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 |
