UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001113 |
|---|---|
| Receipt number | 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 08:40:37 |
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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
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
ayukono-tky@umin.ac.jp
Sponsor or person
Institute
Osaka City University, School of Nursing, Department of Home care Nursing
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001345
