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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01627418




Registration number
NCT01627418
Ethics application status
Date submitted
2/08/2011
Date registered
25/06/2012
Date last updated
17/06/2015

Titles & IDs
Public title
Warm Homes for Elder New Zealanders
Scientific title
Warm Homes for Elder New Zealanders: a Community Trial of People With COPD
Secondary ID [1] 0 0
HRC08/072AR
Universal Trial Number (UTN)
Trial acronym
WHEZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Energy Voucher
BEHAVIORAL - No intervention : control arm

Experimental: Voucher - Receive the intervention ("Energy Voucher") the first winter enrolled in the study. The intervention is a electricity voucher and a short pamphlet describing how to work out how much heat the voucher can buy.

Other: Control - Receive the intervention the second winter enrolled in the study (thus "No intervention : control arm"). The intervention is a electricity voucher and a short pamphlet describing how to work out how much heat the voucher can buy.


BEHAVIORAL: Energy Voucher
Receive the intervention the first winter enrolled in the study. The intervention is a electricity voucher and a short pamphlet describing how to work out how much heat the voucher can buy.

BEHAVIORAL: No intervention : control arm
Do not receive the money or pamphlet in the initial study year
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Moderate or severe exacerbations of COPD during winter for which hospitalisation, systemic corticosteroids and/or antibiotics are required to treat the exacerbation
Timepoint [1] 0 0
Four months
Secondary outcome [1] 0 0
Severe exacerbations of COPD during winter for which hospitalisation is required to treat the exacerbation
Timepoint [1] 0 0
Four months
Secondary outcome [2] 0 0
Moderate exacerbations of COPD during winter; which will be defined as requiring treatment with systemic corticosteroids and/or antibiotics
Timepoint [2] 0 0
Four months
Secondary outcome [3] 0 0
All-cause hospitalisation during winter
Timepoint [3] 0 0
Four months
Secondary outcome [4] 0 0
Temperature in the living and bedrooms during winter
Timepoint [4] 0 0
Four months
Secondary outcome [5] 0 0
Electricity usage during winter
Timepoint [5] 0 0
Four months
Secondary outcome [6] 0 0
Costs to health care system of index participant during winter
Timepoint [6] 0 0
Four months
Secondary outcome [7] 0 0
Self-reported quality of life for index participant during winter
Timepoint [7] 0 0
Four months
Secondary outcome [8] 0 0
Respiratory health of other people living in household during winter
Timepoint [8] 0 0
Four months
Secondary outcome [9] 0 0
Any changes in index participant baseline lung function
Timepoint [9] 0 0
course of study ( up to 18 months)
Secondary outcome [10] 0 0
Study withdrawals due to death or greater dependency
Timepoint [10] 0 0
course of study (up to 18 months)
Secondary outcome [11] 0 0
Support person burden
Timepoint [11] 0 0
course of study (up to 18 months)

Eligibility
Key inclusion criteria
* Post Bronchodilator FEV1/FVC ratio < Lower Limit of Normal (NHanesIII)
* Post Bronchodilator FEV1 < 80% of the predicted FEV1 (NHanesIII)

OR - In the last three years either went to hospital for their COPD or took antibiotics/steriods for their COPD
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Not planning to stay in the same dwelling until the end of the study
* Does not want to take part in research
* Unwilling to answer inclusion questionnaire
* Unable to communicate effectively

Study design
Purpose of the study
Other
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
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2013
Sample size
Target
Accrual to date
Final
522
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch
Country [2] 0 0
New Zealand
State/province [2] 0 0
Wanganui
Country [3] 0 0
New Zealand
State/province [3] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Other
Name
University of Otago
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Health Research Council, New Zealand
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Aim

The purpose of this study is to evaluate whether fuel subsidies reduce exacerbations of COPD among people aged over 55, and therefore whether providing such subsidies is a cost-beneficial policy initiative.

The Warm Homes for Elder New Zealanders Study enrolled community-dwelling people aged over 55 with moderate or worse COPD. Prior to the study commencing the houses were insulated (if feasible, \& the house-owner agreed). Data were collected on the health and energy use of the participants.

The households randomly assigned to the "early" intervention group had a subsidy to their power account their first winter in the study. The subsidy was the intervention and was designed to enable the participants, if they chose to do so, to keep their house warmer during the winter.
Trial website
https://clinicaltrials.gov/study/NCT01627418
Trial related presentations / publications
Viggers H, Howden-Chapman P, Ingham T, Chapman R, Pene G, Davies C, Currie A, Pierse N, Wilson H, Zhang J, Baker M, Crane J. Warm homes for older people: aims and methods of a randomised community-based trial for people with COPD. BMC Public Health. 2013 Feb 26;13:176. doi: 10.1186/1471-2458-13-176.
Public notes

Contacts
Principal investigator
Name 0 0
Philippa L Howden-Chapman, PhD
Address 0 0
University of Otago
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01627418