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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029468
Receipt No. R000033648
Scientific Title A research on effective support for homeless elderly persons
Date of disclosure of the study information 2017/11/01
Last modified on 2020/04/06

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Basic information
Public title A research on effective support for homeless elderly persons
Acronym Effective support for homeless elderly persons
Scientific Title A research on effective support for homeless elderly persons
Scientific Title:Acronym Effective support for homeless elderly persons
Region
Japan

Condition
Condition homeless persons in the shelters
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To measure the effect of the integrated community-based care of mental and physical health on elderly homeless persons
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes QOL
Key secondary outcomes Frailty

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 To conduct a deep interview by the psychiatrist when the homeless person is referred to the institution, and to deliver more person-centered care.
Interventions/Control_2
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
100 years-old >
Gender Male and Female
Key inclusion criteria homeless persons who are 65+ referred to the shelters
Key exclusion criteria those who rejected to participate
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Tsuyoshi
Middle name
Last name Okamura
Organization Tokyo Metropolitan Institute of Gerontology
Division name Research Team for Promoting Independence of the Elderly
Zip code 173-0015
Address 35-2 Sakae-cho, Itabashi-ku, Tokyo, 173-0015, Japan
TEL 080-1079-0492
Email t.okamura.jp@gmail.com

Public contact
Name of contact person
1st name Tsuyoshi
Middle name
Last name Okamura
Organization Tokyo Metropolitan Institute of Gerontology
Division name Research Team for Promoting Independence of the Elderly
Zip code 173-0015
Address 35-2 Sakae-cho, Itabashi-ku, Tokyo, 173-0015, Japan
TEL 080-1079-0492
Homepage URL
Email t.okamura.jp@gmail.com

Sponsor
Institute Tokyo Metropolitan Institute of Gerontology
Institute
Department

Funding Source
Organization Nissei Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical Committee of TMIG
Address 35-2 Sakae-cho, Itabashi-ku, Tokyo, 173-0015, Japan
Tel 03-3964-3241
Email naomi_hasegawa@tmghig.jp

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
2017 Year 11 Month 01 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-bin/icdr/ctr_view.cgi?recptno=R000033648
Publication of results Unpublished

Result
URL related to results and publications https://upload.umin.ac.jp/cgi-bin/icdr/ctr_view.cgi?recptno=R000033648
Number of participants that the trial has enrolled 24
Results
Of 38 older homeless people who arrived at the shelters, 24 participated in our study. Among these, 14 were categorized into the new group. Of the 24 participants who underwent baseline interviews, 16 underwent follow-up assessment. 
Results date posted
2020 Year 04 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Those who underwent baseline assessment were all Japanese, single (5 never married, 19 once married), and mainly male (21 males, 3 females). Only two had a relationship with relatives. They suffered from frailty or pre-frailty (22 out of 24), poor well-being (18 out of 24), and major depressive episodes (11 out of 24). None of the participants were judged to have psychotic disorders.
Participant flow
Of 38 older homeless people who arrived at the shelters, 24 participated in our study. Among these, 14 were categorized into the new group. Of the 24 participants who underwent baseline interviews, 16 underwent follow-up assessment.
Adverse events
none
Outcome measures
We collected both quantitative and qualitative data of older homeless people at the time of coming to the shelter (baseline) and 6 months later (follow-up). In addition, we collected qualitative data from the staff. Quantitative data included physical health (frailty), mental health (WHO-5 Well-being Index and Mini-International Neuropsychiatric Interview), and psychosocial variables (perceived emotional social support, perceived instrumental social support, generalized trust, and relationship with others).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2017 Year 11 Month 01 Day
Date of IRB
2017 Year 12 Month 07 Day
Anticipated trial start date
2017 Year 12 Month 27 Day
Last follow-up date
2019 Year 02 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 07 Day
Last modified on
2020 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033648

Research Plan
Registered date File name
2020/04/06 ふるさとの会研究_計画書_UMIN.pdf

Research case data specifications
Registered date File name
2020/04/06 仕様書.pdf

Research case data
Registered date File name
2020/04/06 結果.pdf


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