UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042196 |
|---|---|
| Receipt number | R000048162 |
| Scientific Title | Nationwide cohort survey on changes in residents' health by energy-saving retrofit of living space in Japan: Smart Wellness Housing survey (SWH cohort survey) |
| Date of disclosure of the study information | 2020/10/21 |
| Last modified on | 2021/05/11 12:06:24 |
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Basic information
Public title
Nationwide cohort survey on changes in residents' health by energy-saving retrofit of living space in Japan: Smart Wellness Housing survey (SWH cohort survey)
Acronym
Nationwide cohort survey on changes in residents' health by energy-saving retrofit of living space in Japan: Smart Wellness Housing survey (SWH cohort survey)
Scientific Title
Nationwide cohort survey on changes in residents' health by energy-saving retrofit of living space in Japan: Smart Wellness Housing survey (SWH cohort survey)
Scientific Title:Acronym
Nationwide cohort survey on changes in residents' health by energy-saving retrofit of living space in Japan: Smart Wellness Housing survey (SWH cohort survey)
Region
| Japan |
Condition
Condition
Hypertensive diseases
Arteriosclerosis
Ischaemic heart diseases
Cerebrovascular diseases
Respiratory diseases
Locomotive syndrome
Sleep disorders
Urological diseases
Mood [affective] disorders
Allergic diseases
Infection
Classification by specialty
| Medicine in general | Cardiology | Pneumology |
| Clinical immunology | Infectious disease | Geriatrics |
| Pediatrics | Dermatology | Psychiatry |
| Oto-rhino-laryngology | Orthopedics | Urology |
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the long-term effect of living in houses with high insulation performance on residents' health all over Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
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)Overactive bladder symptom score; OABSS
(6)SF-8
(7)General Health Questionnaire -12
(8)Pittsburgh Sleep Quality Index
(9)Work Functioning Impairment Scale (WFun)
(10)CASBEE-Health Check list of housing
(11)Antihypertensive drug use
(12)The level of care needed
(13)Death
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Male and female aged 20 and above
However, include parent-reported symptoms and diseases of children under 20 years old
(2)Participants who participated in the Nationwide survey on changes in residents' health by energy-saving retrofit of living space in Japan: Smart Wellness Housing survey (SWH survey)( UMIN Clinical Trials Registry, Trial No. UMIN000030601.)
Key exclusion criteria
(1)Participants who declined measurement
(2)Participants whose number of measurement of indoor temperature, home blood pressure or physical activity were extremely small
(3)Participants with an unavailable data from questionnaires or diaries
(4)Participants whose response to questionnaires and diaries were mismatching
Target sample size
1200
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
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 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/
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
Japanese Governmental office
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
1-15-18 Hachioji, Bessho, Tokyo
Tel
03-3470-3360
reception-office@hattori-crb.com
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
| 2020 | Year | 10 | Month | 21 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Cohort survey of subjects who participated in Nationwide survey on changes in residents' health by energy-saving retrofit of living space in Japan: Smart Wellness Housing survey
(SWH survey) ( UMIN Clinical Trials Registry, Trial No. UMIN000030601.)
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000034946
Management information
Registered date
| 2020 | Year | 10 | Month | 21 | Day |
Last modified on
| 2021 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048162
| 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 |
