UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039121
Receipt number R000044618
Scientific Title Effects of meetinghouse programs on public housing for disasters following the Great East Japan Earthquake
Date of disclosure of the study information 2020/01/15
Last modified on 2020/01/10 17:49:10

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Basic information

Public title

Effects of meetinghouse programs on public housing for disasters following the Great East Japan Earthquake

Acronym

Effects of meetinghouse programs on public housing for disasters following the Great East Japan Earthquake

Scientific Title

Effects of meetinghouse programs on public housing for disasters following the Great East Japan Earthquake

Scientific Title:Acronym

Effects of meetinghouse programs on public housing for disasters following the Great East Japan Earthquake

Region

Japan


Condition

Condition

affected elderly

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

we aim to clarify effect of the program on individuals HRQOL and social health.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

SF-36 score before and after the end of the program

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

The programs were conducted approximately once a week, comprising a total of 14 sessions. Each session was 120 minutes in duration.
A program focused on activities and participation was implemented.

Interventions/Control_2

The programs were conducted approximately once a week, comprising a total of 14 sessions. Each session was 120 minutes in duration.
The program focused on the physical and mental functions and body structures.

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

The inclusion criteria were as follows: being 65 years or older, and having left temporary housing or a relative's house to settle in permanent post-disaster housing in M City, Fukushima Prefecture.

Key exclusion criteria

A person who can communicate orally, and who have not been diagnosed with dementia by a physician.

Target sample size

86


Research contact person

Name of lead principal investigator

1st name Hiroko
Middle name
Last name Shimazaki

Organization

Bunkyo Gakuin University

Division name

Department of Occupational Therapy

Zip code

356

Address

1196 Kamekubo, Fujimino,Saitama, Japan

TEL

0492617942

Email

hshimazaki@bgu.ac.jp


Public contact

Name of contact person

1st name Hiroko
Middle name
Last name Shimazaki

Organization

Bunkyou Gakuin University

Division name

Department of Occupational Therapy

Zip code

3568533

Address

1196 Kamekubo, Fujimino,Saitama, Japan

TEL

0492617942

Homepage URL


Email

hshimazaki@bgu.ac.jp


Sponsor or person

Institute

Bunkyou Gakuin University

Institute

Department

Personal name



Funding Source

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Bunkyo Gakuin University

Address

1196 Kamekubo, Fujimino,Saitama, Japan

Tel

0492617942

Email

hshimazaki@bgu.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

17K13884

Org. issuing International ID_1

Japan Science and Technology Agency

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2020 Year 01 Month 15 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

86

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

2016 Year 01 Month 10 Day

Date of IRB

2016 Year 03 Month 01 Day

Anticipated trial start date

2016 Year 04 Month 01 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 01 Month 10 Day

Last modified on

2020 Year 01 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044618


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name