UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006463 |
|---|---|
| Receipt number | 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 11:19:25 |
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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
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
ayukono@nurs.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007671
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
