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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006463
Receipt No. R000007671
Scientific Title Development and effects of preventive home visit program among ambulatory frail older people living at home
Date of disclosure of the study information 2011/10/04
Last modified on 2017/04/07

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Basic information
Public title Development and effects of preventive home visit program among ambulatory frail older people living at home
Acronym Development and effects of preventive home visit program among frail older people living at home
Scientific Title Development and effects of preventive home visit program among ambulatory frail older people living at home
Scientific Title:Acronym Development and effects of preventive home visit program among frail older people living at home
Region
Japan

Condition
Condition Support Level 1 or 2 certified by the Japanese Long-Term Care Insurance system
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop and examine the effects of a strucutured preventive home visit program.
Basic objectives2 Others
Basic objectives -Others To examine the difference of the effects of the preventive home visit program according to ADLs
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes ADLs
Functional Capacity
Social activities-related daily life satisfaction
Metamemory:capacity
Depression
Self-efficay of health promotion
Key secondary outcomes Long-term care utilization

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Providing home visits once per 3-months for 2-years conducted by care managers or nurses in community-based comprehensive care centers, including structured comprehensive assessments and recommendations to participants
Interventions/Control_2 Providing usual care.
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 Living at home.
Certified as Support Level 1 or 2 by the Long-Term Care Insurance System at baseline.
Being Clients the community- based comprehensive care centers participated in the projects.
Having informed consent.
Key exclusion criteria Being at hospital or institutionalized at baseline.
Target sample size 360

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ayumi Kono
Organization Osaka City University
Division name School of Nursing
Zip code
Address 1-5-17 Asahi, Abeno, Osaka
TEL 06-6645-3540
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ayumi Kono
Organization Osaka City University
Division name School of Nursing
Zip code
Address 1-5-17 Asahi, Abeno, Osaka
TEL 06-6645-3540
Homepage URL
Email ayukono@nurs.osaka-cu.ac.jp

Sponsor
Institute Osaka City University
Institute
Department

Funding Source
Organization Japan Society for the promotion of science: Kiban-B
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Osaka Prefecture University
Konan Women's University
Oklahoma University
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 大阪府岬町・岬町地域包括支援センター
大阪府泉南市・泉南市地域包括支援センター
大阪府大東市・大東市地域包括支援センター

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2011 Year 04 Month 30 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
2015 Year 01 Month 31 Day
Date of closure to data entry
2015 Year 01 Month 31 Day
Date trial data considered complete
2015 Year 01 Month 31 Day
Date analysis concluded
2016 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 10 Month 04 Day
Last modified on
2017 Year 04 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007671

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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