Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000160235
Ethics application status
Approved
Date submitted
8/01/2018
Date registered
2/02/2018
Date last updated
21/01/2020
Date data sharing statement initially provided
21/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Outcomes evaluation of the Victorian Healthy Homes Program: a staggered parallel group cluster randomised controlled trial assessing the thermal comfort and health benefits of home energy efficiency improvements
Scientific title
Outcomes evaluation of the Victorian Healthy Homes Program: a staggered parallel group cluster randomised controlled trial assessing the thermal comfort and health benefits of home energy efficiency improvements
Secondary ID [1] 293723 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
General health (self-reported) 306074 0
Respiratory health (Asthma/COPD) 306075 0
Cardio-vascular health 306076 0
Thermal comfort in winter 306077 0
Condition category
Condition code
Cardiovascular 305211 305211 0 0
Normal development and function of the cardiovascular system
Respiratory 305212 305212 0 0
Normal development and function of the respiratory system
Public Health 305453 305453 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The primary objective of a household energy efficiency retrofit in the Victorian Healthy Homes Program is to minimise winter heat loss in the home and improve thermal comfort. A range of retrofit measures can increase household energy efficiency. These include improvements to: ceiling insulation, underfloor insulation, space heating or cooling, window protection, water heaters, draught sealing external door, shower water efficiency, ventilation and lighting.

The Energy Liaison Officer visiting each house will be tasked with identifying physical and behavioural aspects of the household that will enable the determination of the types of retrofit measures that would improve winter thermal comfort, i.e. repairing a broken window or door causing cool air to enter the home.

A Residential (Energy) Efficiency Scorecard assessment will also be administered in each home prior to any retrofit occurring. The Scorecard provides a cost-based metric of the energy efficiency of a home as well as actions that would improve a home’s energy efficiency.

The final decision on which retrofit measures will be performed in each home will be based on:
- subjective (perceived) winter thermal comfort from householders where winter thermal comfort questions are asked from recruitment as well as following formal entry into the Victorian Healthy Homes Program; AND
- subjective assessment by the Energy Liaison Officer of measures that can be introduced to improve winter thermal comfort; AND
- objective assessment of measures and recommended energy efficiency remediation actions from the Residential Efficiency Scorecard.

Energy Liaison Officers will visit the participant’s home twice, once before winter and again after winter. During the first visit, the Energy Liaison Officer visiting each house will be tasked with identifying physical or behavioural aspects of the household to determine the types of retrofit measures that would improve winter thermal comfort, i.e. repairing a broken window or door causing cool air to enter the home. They will also give the participant and any other participating adults in the household a survey to complete before and after winter about how they rate their health and wellbeing.

The intervention period for the purposes of the study is the astronomical winter period (22 June to 21 September) in either 2018 or 2019 or 2020. However, the home modifications will remain as permanent fixtures unless the householder chooses to have them removed after the study. For the self-reported survey measures, there will be two assessments. One in the period between February 2018-May 2018 or November 2018-May 2019 or November 2019-May 2020 (before winter) and the second in October 2018-February 2019 or October 2019-February 2020 or October 2020-February 2021 (after winter).

The Energy Liaison Officer will assess the required improvements and then arrange for the work to be performed. The required improvements will vary between households but will be selected from the range of improvements available for the study and will be recorded for each household. An audit of the home improvements will be conducted by an independent auditor. The focus will therefore be on ensuring the quality and safety of the program implementation rather than fidelity per se, given there will be variation among households in the type of intervention required.
Intervention code [1] 299973 0
Prevention
Intervention code [2] 299974 0
Lifestyle
Comparator / control treatment
A staggered parallel group clustered randomised controlled trial design will be used to evaluate the primary outcome of the Victorian Healthy Homes Program. The intervention group will receive the intervention prior to either winter 2018 or winter 2019 or winter 2020 and the control group will receive the intervention after winter 2018 or after winter 2019 or after winter 2020. The rollout of the Program will be staggered by local government area with data collection occurring in parallel for both the intervention and control groups. The comparator group will receive the interventions after the winter period. Clustering will occur for individuals at the household level.
Control group
Active

Outcomes
Primary outcome [1] 304367 0
Temperature within the home - outcome variable specified as mean difference in temperature.

Temperature will be measured in degrees Celsius by a data logger placed in the home.
Timepoint [1] 304367 0
Daily measurements taken throughout June, July, August and September 2018 or 2019 or 2020.
Primary outcome [2] 304597 0
Temperature within the home – outcome variable specified as the number of days below comfort thresholds.

Temperature will be measured in degrees Celsius by a data logger placed in the home.

Comfort thresholds will be based on a threshold temperature that captures when a person’s comfort is impacted by cold temperatures (for example, 18 degrees is the temperature at which a day becomes a heating-degree day in this example from the Australian Bureau of Meteorology - http://www.bom.gov.au/climate/map/heating-cooling-degree-days/documentation.shtml ).
Timepoint [2] 304597 0
Daily measurements taken throughout June, July, August and September 2018 or 2019 or 2020.
Secondary outcome [1] 341741 0
Household outcome 1 – Humidity within the home (measured by a data logger)
Timepoint [1] 341741 0
Daily measurements taken throughout June, July, August and September 2018 or 2019 or 2020.
Secondary outcome [2] 341742 0
Household outcome 2 – Change in the amount of mould/mildew observed by the household.

This a self-reported outcome with four levels (i.e. no visible mould/mildew, specks of mould/mildew, moderate mould/mildew patches, extensive discoloured areas due to mould/mildew).
Timepoint [2] 341742 0
Single assessment made in the period between February 2018-May 2018 or November 2018-May 2019 or November 2019-May 2020 (before winter) and October-February 2018/19 or 2019/20 or 2020/21 (after winter).
Secondary outcome [3] 341743 0
Household outcome 3 – Change in the amount of damp observed by the household.
This a self-reported outcome with two levels (i.e. yes – damp was noticed and no – damp was not noticed).
Timepoint [3] 341743 0
Single assessment made in the period between February 2018-May 2018 or November 2018-May 2019 or November 2019-May 2020 (before winter) and October-February 2018/19 or 2019/20 or 2020/21 (after winter).
Secondary outcome [4] 341744 0
Household outcome 4 – Energy use by the household

This will be assessed using household energy consumption and billing data held by energy retailers. This information will be collected up to 2 years before and up to 1 year after the upgrade.
Timepoint [4] 341744 0
Daily measurements taken throughout June, July, August and September 2018 or 2019 or 2020.
Secondary outcome [5] 341745 0
Household outcome 5 – Cost-benefit analysis of the intervention

This outcome will be assessed by comparing the costs of the program to the benefits associated with changes in health utilisation, quality of life, energy consumption and greenhouse gas emissions.
Timepoint [5] 341745 0
This will be an assessment made using the entire implementation period between February 2018 and September 2020.
Secondary outcome [6] 341746 0
Individual outcome 1 – Health related quality of life (SF-36, EQ-5D-5L and ASCOT instruments)
Timepoint [6] 341746 0
Single assessment made in the period between February 2018-May 2018 or November 2018-May 2019 or November 2019-May 2020 (before winter) and October-February 2018/19 or 2019/20 or 2020/21 (after winter).
Secondary outcome [7] 341747 0
Individual outcome 2 – Respiratory symptoms

This will be assessed using the Medical Research Council (MRC) dyspnoea scale (which is a self-completed question asking about shortness of breath).
Timepoint [7] 341747 0
Single assessment made in the period between February 2018-May 2018 or November 2018-May 2019 or November 2019-May 2020 (before winter) and October-February 2018/19 or 2019/20 or 2020/21 (after winter).
Secondary outcome [8] 341748 0
Individual outcome 3 – Healthcare utilisation during winter (including hospitalisations, emergency department presentations, primary care visits and pharmaceuticals)

Differences between mean/median counts of these variables between the intervention and control groups.

These data will be sourced from administration records and will be provided by the relevant Federal and State government organisations. For example, de-identified MBS and PBS data will be sourced from the Department of Human Services.
Timepoint [8] 341748 0
These data will be aggregated to be count variables for each individual and will capture utilisation during the winter periods between June, July, August and September 2018 or 2019 or 2020.
Secondary outcome [9] 341749 0
Individual outcome 4 – Absenteeism from school/work

This is a self-reported question that asks for the number of days that household members were absent from work/school.
Timepoint [9] 341749 0
Single assessment made for the winter periods between June, July, August and September 2018 or 2019 or 2020.

Eligibility
Key inclusion criteria
This research focuses on low-income households where at least one person has need for home care support services or has an existing health condition. To be eligible for this research project, you need to be aged 18 years or more, have lived in your current home for one year or more and live in Western Melbourne or the Goulburn Valley and:
- have any one of the Commonwealth concession cards listed below and are receiving home care support services provided through your local council or other community organisation and plan to reside in your home for 2 years or more
OR
- have any one of the Commonwealth concession cards listed below and are part of the Victorian Government’s Health Independence Program/Complex Care Program and plan to stay in reside in your home for 2 years or more
OR
- have any one of the Commonwealth concession cards listed below and have a chronic respiratory disease and plan to reside in your home for 2 years or more.

People with the following types of Commonwealth concession cards are eligible to participate in this study:
- Commonwealth (Centrelink) Health Care Card
- Commonwealth (Centrelink) Pensioner Concession Card
- Department of Veterans’ Affairs (DVA) Pensioner Concession Card
- Department of Veteran’s Affairs (DVA) Gold Cold – For All Conditions.
This research is open to people living in any housing tenure type, for example owner-occupier, private rental, and public and community housing.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they cannot answer ‘yes’ to all of the following:
1. Is the potential study participant aged 18 years or more?
2. Has the potential participant lived in their current home for one year or more?
3. Does the potential participant live in either Western Melbourne or Goulburn Valley?
4. Is the potential participant low-income as defined by having one of the Commonwealth Concession cards listed below?
5. Is the potential participant:
5a. receiving home care community services from their local government or other community organisation OR
5b. receiving services through the DHHS Health Independence Program/Complex Care Program OR
5c. Has a chronic respiratory disease such as COPD/asthma?
6. Is the potential participant planning to stay in their home for 2 years or more?
Update Key exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/02/2018
Actual
22/02/2018
Date of last participant enrolment
Anticipated
31/05/2020
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
1000
Accrual to date
694
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 298339 0
Government body
Name [1] 298339 0
Sustainability Victoria
Country [1] 298339 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
University of Technology Sydney

Level 2, Building 5D, 1-59 Quay Street, Haymarket NSW 2000

PO Box 123, Broadway NSW 2007
Country
Australia
Secondary sponsor category [1] 297456 0
None
Name [1] 297456 0
Address [1] 297456 0
Country [1] 297456 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299331 0
Department of Health and Human Services Human Research Ethics Committee (DHHS HREC)
Ethics committee address [1] 299331 0
Ethics committee country [1] 299331 0
Australia
Date submitted for ethics approval [1] 299331 0
18/05/2017
Approval date [1] 299331 0
21/07/2017
Ethics approval number [1] 299331 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80082 0
Mr Stan Krpan
Address 80082 0
Sustainability Victoria
Urban Workshop
Level 28, 50 Lonsdale St
Melbourne Vic 3000
Country 80082 0
Australia
Phone 80082 0
+61 3 8626 8848
Fax 80082 0
Email 80082 0
[email protected]
Contact person for public queries
Name 80083 0
Matthew Soeberg
Address 80083 0
Sustainability Victoria
Urban Workshop
Level 28, 50 Lonsdale St
Melbourne Vic 3000
Country 80083 0
Australia
Phone 80083 0
+61 3 8626 8704
Fax 80083 0
Email 80083 0
[email protected]
Contact person for scientific queries
Name 80084 0
Rosalie Viney
Address 80084 0
University of Technology Sydney

Level 2, Building 5D, 1-59 Quay Street, Haymarket NSW 2000

PO Box 123, Broadway NSW 2007
Country 80084 0
Australia
Phone 80084 0
+61 2 9514 4722
Fax 80084 0
Email 80084 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant privacy and confidentiality needs to be preserved.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluation of the Victorian Healthy Homes Program: protocol for a randomised controlled trial.2022https://dx.doi.org/10.1136/bmjopen-2021-053828
N.B. These documents automatically identified may not have been verified by the study sponsor.