Clinical trial NCT01627418: Warm Homes for Elder New Zealanders
Official title: Warm Homes for Elder New Zealanders: a Community Trial of People With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
CORD
COAD
Lead sponsor: University of Otago
Sponsor class: OTHER
Collaborators: name: Health Research Council, New Zealand
First posted: 2012-06-25
Enrollment: 522
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Moderate or severe exacerbations of COPD during winter for which hospitalisation, systemic corticosteroids and/or antibiotics are required to treat the exacerbation
timeFrame: Four months
Secondary outcomes:
measure: Severe exacerbations of COPD during winter for which hospitalisation is required to treat the exacerbation
timeFrame: Four months
measure: Moderate exacerbations of COPD during winter; which will be defined as requiring treatment with systemic corticosteroids and/or antibiotics
timeFrame: Four months
measure: All-cause hospitalisation during winter
timeFrame: Four months
measure: Temperature in the living and bedrooms during winter
timeFrame: Four months
measure: Electricity usage during winter
timeFrame: Four months
measure: Costs to health care system of index participant during winter
timeFrame: Four months
measure: Self-reported quality of life for index participant during winter
timeFrame: Four months
measure: Respiratory health of other people living in household during winter
timeFrame: Four months
measure: Any changes in index participant baseline lung function
timeFrame: course of study ( up to 18 months)
measure: Study withdrawals due to death or greater dependency
timeFrame: course of study (up to 18 months)
measure: Support person burden
timeFrame: course of study (up to 18 months)
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
facility: Christchurch
city: Wanganui
country: New Zealand
facility: Wanganui / Manawatu
city: Wellington
country: New Zealand
facility: Wellington / Hutt/ Porirua
Study officials:
affiliation: University of Otago
name: Philippa L Howden-Chapman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.