- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
-
Christchurch, Nowa Zelandia
- Christchurch
-
Wanganui, Nowa Zelandia
- Wanganui / Manawatu
-
Wellington, Nowa Zelandia
- Wellington / Hutt/ Porirua
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
|
Inny: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
Moderate or severe exacerbations of COPD during winter for which hospitalisation, systemic corticosteroids and/or antibiotics are required to treat the exacerbation
Ramy czasowe: Four months
|
Four months
|
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
|
Severe exacerbations of COPD during winter for which hospitalisation is required to treat the exacerbation
Ramy czasowe: Four months
|
Four months
|
|
Moderate exacerbations of COPD during winter; which will be defined as requiring treatment with systemic corticosteroids and/or antibiotics
Ramy czasowe: Four months
|
Four months
|
|
All-cause hospitalisation during winter
Ramy czasowe: Four months
|
Four months
|
|
Temperature in the living and bedrooms during winter
Ramy czasowe: Four months
|
Four months
|
|
Electricity usage during winter
Ramy czasowe: Four months
|
Four months
|
|
Costs to health care system of index participant during winter
Ramy czasowe: Four months
|
Four months
|
|
Self-reported quality of life for index participant during winter
Ramy czasowe: Four months
|
Four months
|
|
Respiratory health of other people living in household during winter
Ramy czasowe: Four months
|
Four months
|
|
Any changes in index participant baseline lung function
Ramy czasowe: course of study ( up to 18 months)
|
course of study ( up to 18 months)
|
|
Study withdrawals due to death or greater dependency
Ramy czasowe: course of study (up to 18 months)
|
course of study (up to 18 months)
|
|
Support person burden
Ramy czasowe: course of study (up to 18 months)
|
course of study (up to 18 months)
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Philippa L Howden-Chapman, PhD, University of Otago
Publikacje i pomocne linki
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- HRC08/072AR
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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