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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032307
Receipt No. 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

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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
Email 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
Email furuta-kenichiro@ed.tmu.ac.jp

Sponsor
Institute Tokyo Metroporitan University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036843

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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