- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01627418
Warm Homes for Elder New Zealanders (WHEZ)
Warm Homes for Elder New Zealanders: a Community Trial of People With COPD
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Christchurch, Nový Zéland
- Christchurch
-
Wanganui, Nový Zéland
- Wanganui / Manawatu
-
Wellington, Nový Zéland
- Wellington / Hutt/ Porirua
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
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.
|
|
Jiný: 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.
|
Do not receive the money or pamphlet in the initial study year
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Moderate or severe exacerbations of COPD during winter for which hospitalisation, systemic corticosteroids and/or antibiotics are required to treat the exacerbation
Časové okno: Four months
|
Four months
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Severe exacerbations of COPD during winter for which hospitalisation is required to treat the exacerbation
Časové okno: Four months
|
Four months
|
|
Moderate exacerbations of COPD during winter; which will be defined as requiring treatment with systemic corticosteroids and/or antibiotics
Časové okno: Four months
|
Four months
|
|
All-cause hospitalisation during winter
Časové okno: Four months
|
Four months
|
|
Temperature in the living and bedrooms during winter
Časové okno: Four months
|
Four months
|
|
Electricity usage during winter
Časové okno: Four months
|
Four months
|
|
Costs to health care system of index participant during winter
Časové okno: Four months
|
Four months
|
|
Self-reported quality of life for index participant during winter
Časové okno: Four months
|
Four months
|
|
Respiratory health of other people living in household during winter
Časové okno: Four months
|
Four months
|
|
Any changes in index participant baseline lung function
Časové okno: course of study ( up to 18 months)
|
course of study ( up to 18 months)
|
|
Study withdrawals due to death or greater dependency
Časové okno: course of study (up to 18 months)
|
course of study (up to 18 months)
|
|
Support person burden
Časové okno: course of study (up to 18 months)
|
course of study (up to 18 months)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Philippa L Howden-Chapman, PhD, University of Otago
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- HRC08/072AR
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