UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030601
Receipt number R000034946
Scientific Title Nationwide survey on changes in residents' health by energy-saving retrofit of living space in Japan: Smart Wellness Housing survey (SWH survey)
Date of disclosure of the study information 2017/12/27
Last modified on 2021/04/22 14:42:21

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Basic information

Public title

Nationwide survey on changes in residents' health by energy-saving retrofit of living space in Japan: Smart Wellness Housing survey (SWH survey)

Acronym

Nationwide survey on changes in residents' health by energy-saving retrofit of living space in Japan: Smart Wellness Housing survey (SWH survey)

Scientific Title

Nationwide survey on changes in residents' health by energy-saving retrofit of living space in Japan: Smart Wellness Housing survey (SWH survey)

Scientific Title:Acronym

Nationwide survey on changes in residents' health by energy-saving retrofit of living space in Japan: Smart Wellness Housing survey (SWH survey)

Region

Japan


Condition

Condition

Hypertensive diseases
Arteriosclerosis
Ischaemic heart diseases
Cerebrovascular diseases
Respiratory diseases
Locomotive syndrome
Sleep disorders
urological diseases
Mood [affective] disorders

Classification by specialty

Medicine in general Cardiology Geriatrics
Chest surgery Pediatrics Dermatology
Psychiatry Oto-rhino-laryngology Orthopedics
Urology Emergency medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of insulation retrofit on residents' health all over Japan.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Home blood pressure

Key secondary outcomes

(1)Indoor temperature and humidity
(2)Physical activity
(3)Result of medical examination
(4)Self-reported symptoms and diseases
(5)Parent-reported symptoms and diseases of children
(6)Overactive bladder symptom score; OABSS
(7)SF-8
(8)General Health Questionnaire -12
(9)Pittsburgh Sleep Quality Index
(10)Work Functioning Impairment Scale (WFun)
(11)CASBEE-Health_Checklist of housing


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Insulation retrofit of houses to a level that meets either A or S standards of "Promotion of Long life high-quality housing ."

Interventions/Control_2

Control:
without insulation retrofit

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Male and female aged 20 and above
However, include parent-reported symptoms and diseases of children under 20 years old

Key exclusion criteria

(1)Participants who declined measurement
(2)Participants whose houses meet S standards before insulation retrofit
(3)Participants whose number of measurement of indoor temperature, home blood pressure or physical activity were extremely small
(4)Participants with an unavailable data from questionnaires or diaries
(5)Participants whose response to questionnaires and diaries were mismatching

Target sample size

6000


Research contact person

Name of lead principal investigator

1st name Shuzo
Middle name
Last name Murakami

Organization

Institute for Building Environment and Energy Conservation

Division name

President

Zip code

1020083

Address

Zenkyoren bldg.Kojimachikan, 3-5-1, Kojimachi, Chiyoda-ku, Tokyo, Japan

TEL

03-3222-6681

Email

murakami@ibec.or.jp


Public contact

Name of contact person

1st name Hirofumi
Middle name
Last name Ida

Organization

Japan Sustainable Building Consortium

Division name

Research and Development department

Zip code

1020083

Address

Zenkyoren bldg.Kojimachikan, 3-5-1, Kojimachi, Chiyoda-ku, Tokyo, Japan

TEL

03-3222-6391

Homepage URL

http://swhsurvey.jsbc.or.jp/

Email

swhsurvey@jsbc.or.jp


Sponsor or person

Institute

Japan Sustainable Building Consortium

Institute

Department

Personal name



Funding Source

Organization

Ministry of Land, Infrastructure, Transport and Tourism

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hattori clinic ethics review board

Address

Yoyogi TH&C Bld. 5F, 4-26-11 Sendagaya, Shibuya-ku, Tokyo, Japan

Tel

03-6804-2227

Email

cns_jimu@triad-j.co.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 12 Month 27 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

http://www.mlit.go.jp/report/press/house07_hh_000164.html

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

No longer recruiting

Date of protocol fixation

2014 Year 10 Month 14 Day

Date of IRB

2014 Year 11 Month 06 Day

Anticipated trial start date

2014 Year 11 Month 11 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2020 Year 08 Month 31 Day

Date trial data considered complete

2020 Year 12 Month 31 Day

Date analysis concluded

2021 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 12 Month 27 Day

Last modified on

2021 Year 04 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034946


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name