UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021950 |
|---|---|
| Receipt number | R000025313 |
| Scientific Title | Development of coaching program to prevent conditions which requires nursing care for single elderly people and elderly couples. |
| Date of disclosure of the study information | 2019/03/31 |
| Last modified on | 2016/04/17 17:23:14 |
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Basic information
Public title
Development of coaching program to prevent conditions which requires nursing care for single elderly people and elderly couples.
Acronym
Development of program to prevent conditions which requires nursing care.
Scientific Title
Development of coaching program to prevent conditions which requires nursing care for single elderly people and elderly couples.
Scientific Title:Acronym
Development of program to prevent conditions which requires nursing care.
Region
| Japan |
Condition
Condition
healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate the effects of a coaching program to improvement stress-cognition in normal healthy elderly people without nursing care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health-related QOL,Geriatric Depression Scale,Mini Mental State Examination.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
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
The Coaching Program 10 hours
Interventions/Control_2
Ordinary life
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
Single elderly people and elderly couples without nursing car.
Key exclusion criteria
No establish
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ohashi Junko |
Organization
Kyoto prefectural university of medicine
Division name
Graduate school of nursing
Zip code
Address
465 kajii-cho kawaramachi agaru hirokoji kamigyo-ku koto Japan
TEL
075-212-5440
johashi@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ohashi Junko |
Organization
Kyoto prefectural university of medicine
Division name
Graduate school of nursing
Zip code
Address
465 kajii-cho kawaramachi agaru hirokoji kamigyo-ku koto Japan
TEL
075-212-5440
Homepage URL
johashi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto prefectural university of medicine graduate school of nursing
Institute
Department
Personal name
Funding Source
Organization
Kyoto prefectural university of medicine graduate school of nursing
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
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
| 2019 | Year | 03 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 12 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 31 | 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
| 2016 | Year | 04 | Month | 17 | Day |
Last modified on
| 2016 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025313
