Chronic Obstructive Pulmonary Disease Clinical Trial
— WHEZOfficial title:
Warm Homes for Elder New Zealanders: a Community Trial of People With COPD
| Verified date | June 2015 |
| Source | University of Otago |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | New Zealand: Health Research Council |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 522 |
| Est. completion date | February 2013 |
| Est. primary completion date | February 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 55 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| New Zealand | Christchurch | Christchurch | |
| New Zealand | Wanganui / Manawatu | Wanganui | |
| New Zealand | Wellington / Hutt/ Porirua | Wellington |
| Lead Sponsor | Collaborator |
|---|---|
| University of Otago | Health Research Council, New Zealand |
New Zealand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Moderate or severe exacerbations of COPD during winter for which hospitalisation, systemic corticosteroids and/or antibiotics are required to treat the exacerbation | Four months | No | |
| Secondary | Severe exacerbations of COPD during winter for which hospitalisation is required to treat the exacerbation | Four months | No | |
| Secondary | Moderate exacerbations of COPD during winter; which will be defined as requiring treatment with systemic corticosteroids and/or antibiotics | Four months | No | |
| Secondary | All-cause hospitalisation during winter | Four months | No | |
| Secondary | Temperature in the living and bedrooms during winter | Four months | No | |
| Secondary | Electricity usage during winter | Four months | No | |
| Secondary | Costs to health care system of index participant during winter | Four months | No | |
| Secondary | Self-reported quality of life for index participant during winter | Four months | No | |
| Secondary | Respiratory health of other people living in household during winter | Four months | No | |
| Secondary | Any changes in index participant baseline lung function | course of study ( up to 18 months) | No | |
| Secondary | Study withdrawals due to death or greater dependency | course of study (up to 18 months) | No | |
| Secondary | Support person burden | course of study (up to 18 months) | No |
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