UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of coaching program to prevent conditions which requires nursing care for single elderly people and elderly couples.
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Ohashi Junko
Organization	Kyoto prefectural university of medicine
Division name	Graduate school of nursing
Address	465 kajii-cho kawaramachi agaru hirokoji kamigyo-ku koto Japan
TEL	075-212-5440
Email	johashi@koto.kpu-m.ac.jp

Public contact
Name of contact person	Ohashi Junko
Organization	Kyoto prefectural university of medicine
Division name	Graduate school of nursing
Address	465 kajii-cho kawaramachi agaru hirokoji kamigyo-ku koto Japan
TEL	075-212-5440
Homepage URL
Email	johashi@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto prefectural university of medicine graduate school of nursing
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 12 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025313