UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029468
Receipt number 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 2022/10/10 17:44:49

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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 or person

Institute

Tokyo Metropolitan Institute of Gerontology

Institute

Department

Personal name



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

Completed

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

2022 Year 10 Month 10 Day

Date trial data considered complete

2022 Year 10 Month 10 Day

Date analysis concluded

2022 Year 10 Month 10 Day


Other

Other related information



Management information

Registered date

2017 Year 10 Month 07 Day

Last modified on

2022 Year 10 Month 10 Day



Link to view the page

Value
https://center6.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