Warm Homes for Elder New Zealanders (WHEZ)

Tracking Information
First Submitted Date ICMJE	August 2, 2011
First Posted Date ICMJE	June 25, 2012
Last Update Posted Date	June 17, 2015
Study Start Date ICMJE	April 2009
Actual Primary Completion Date	February 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 20, 2012)	Moderate or severe exacerbations of COPD during winter for which hospitalisation, systemic corticosteroids and/or antibiotics are required to treat the exacerbation [ Time Frame: Four months ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01627418 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 20, 2012)	Severe exacerbations of COPD during winter for which hospitalisation is required to treat the exacerbation [ Time Frame: Four months ]; Moderate exacerbations of COPD during winter; which will be defined as requiring treatment with systemic corticosteroids and/or antibiotics [ Time Frame: Four months ]; All-cause hospitalisation during winter [ Time Frame: Four months ]; Temperature in the living and bedrooms during winter [ Time Frame: Four months ]; Electricity usage during winter [ Time Frame: Four months ]; Costs to health care system of index participant during winter [ Time Frame: Four months ]; Self-reported quality of life for index participant during winter [ Time Frame: Four months ]; Respiratory health of other people living in household during winter [ Time Frame: Four months ]; Any changes in index participant baseline lung function [ Time Frame: course of study ( up to 18 months) ]; Study withdrawals due to death or greater dependency [ Time Frame: course of study (up to 18 months) ]; Support person burden [ Time Frame: course of study (up to 18 months) ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Warm Homes for Elder New Zealanders
Official Title ICMJE	Warm Homes for Elder New Zealanders: a Community Trial of People With COPD
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.
Detailed Description	Warm Homes for Elder New Zealanders (WHEZ) Background Although there has been considerable recent work on the prevention, management and causes of Chronic Obstructive Pulmonary Disease (COPD), the contribution of housing has not been well researched. This is despite the socio-economic patterning of COPD (Maori women have the highest rate of COPD that has been recorded for any group of women), and the relationship between socio-economic deprivation and housing conditions. It is likely that improved heating would reduce exacerbations of COPD as: COPD patients with the most advanced disease tend to be older people who often live on a fixed income and may be unable to afford adequate heating; There is a high excess of winter hospitalisations in COPD patients indicating COPD exacerbations may be triggered by cold conditions.; About one third of exacerbations of COPD are triggered by respiratory infections.; The Housing, Insulation and Health Study demonstrated a reduction in self-reported respiratory disease after houses were insulated. Therefore improving the heating in households with a COPD patient may reduce respiratory infections and this in turn would reduce the number and severity of exacerbations. The percentage of people over 65 in New Zealand will increase from 12% to 22% over the next 25 years. Therefore it will become increasingly important to find cost-effective ways of reducing the morbidity of the older age group. As COPD is a significant cause of morbidity amongst older people, this study investigates a potentially cost effective intervention to reduce both the likelihood of expensive hospital stays and improve the quality of life for older people. Aim 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. Potential Benefits The potential benefits of the study include reducing the burden of disease. The patients and their caregivers may experience improved quality of life. Hospitals may experience fewer patients requiring treatment during the winter. A cost-benefit analysis will quantify the benefits.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Supportive Care
Condition ICMJE	Chronic Obstructive Pulmonary Disease
Intervention ICMJE	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
Study Arms	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. Intervention: Behavioral: Energy Voucher; 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. Intervention: Behavioral: No intervention : control arm
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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: June 15, 2015)	522
Original Estimated Enrollment ICMJE; (submitted: June 20, 2012)	600
Actual Study Completion Date	February 2013
Actual Primary Completion Date	February 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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 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
Sex/Gender	Sexes Eligible for Study: All
Ages	55 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	New Zealand
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01627418
Other Study ID Numbers ICMJE	HRC08/072AR
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Philippa Howden-Chapman, University of Otago
Study Sponsor ICMJE	University of Otago
Collaborators ICMJE	Health Research Council, New Zealand
Investigators ICMJE	Principal Investigator: Philippa L Howden-Chapman, PhD University of Otago
PRS Account	University of Otago
Verification Date	June 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP