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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001113
Receipt No. R000001345
Scientific Title Effects of preventive home visits for ambulatory frail elders: a randomized clinical trial in Osaka, Japan
Date of disclosure of the study information 2008/04/07
Last modified on 2010/04/08

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Basic information
Public title Effects of preventive home visits for ambulatory frail elders: a randomized clinical trial in Osaka, Japan
Acronym Preventive Home Visit for Frail Elders: Osaka Study
Scientific Title Effects of preventive home visits for ambulatory frail elders: a randomized clinical trial in Osaka, Japan
Scientific Title:Acronym Preventive Home Visit for Frail Elders: Osaka Study
Region
Japan

Condition
Condition Geriatric Syndrome
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the study is to evaluate the effects of preventive home visits for frail ambulatory elders living at home.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Activities of Daily Livings
Institutionalization
Mortality
Hospitalization
Instrumental Activities of Daily Livings
Key secondary outcomes Health Care Utilization Costs
Long Term Care Utilization Costs
Social Support
Depression

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 Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Home visits based on specific care assessment model conducted by community care nurses or workers
Interventions/Control_2 Routine community based 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 1.Certified as being in the two lowest care needs levels in the LTCI(Long Term Care Insurance)
2.Living at home at the baseline survey
3.Not utilizing the LTCI services
Key exclusion criteria 1.Utilizing the LTCI services within two months
Target sample size 323

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ayumi Kono
Organization Osaka City University, School of Nursing
Division name Department of Home Care Nursing
Zip code
Address 1-5-17 Asahi, Abeno, Osaka 545-0051
TEL 06-6645-3540
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ayumi Kono
Organization Osaka City University, School of Nursing
Division name Department of Home Care Nursing
Zip code
Address 1-5-17 Asahi, Abeno, Osaka 545-0051
TEL 06-6645-3540
Homepage URL
Email ayukono-tky@umin.ac.jp

Sponsor
Institute Osaka City University, School of Nursing, Department of Home care Nursing
Institute
Department

Funding Source
Organization the Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2008 Year 04 Month 07 Day

Related information
URL releasing protocol
Publication of results Partially 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
2008 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2008 Year 01 Month 01 Day
Last follow-up date
2010 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2011 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 04 Month 07 Day
Last modified on
2010 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001345

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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