- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Christchurch, Nova Zelândia
- Christchurch
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Wanganui, Nova Zelândia
- Wanganui / Manawatu
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Wellington, Nova Zelândia
- Wellington / Hutt/ Porirua
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
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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.
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Outro: 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.
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Do not receive the money or pamphlet in the initial study year
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Moderate or severe exacerbations of COPD during winter for which hospitalisation, systemic corticosteroids and/or antibiotics are required to treat the exacerbation
Prazo: Four months
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Four months
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Severe exacerbations of COPD during winter for which hospitalisation is required to treat the exacerbation
Prazo: Four months
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Four months
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Moderate exacerbations of COPD during winter; which will be defined as requiring treatment with systemic corticosteroids and/or antibiotics
Prazo: Four months
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Four months
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All-cause hospitalisation during winter
Prazo: Four months
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Four months
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Temperature in the living and bedrooms during winter
Prazo: Four months
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Four months
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Electricity usage during winter
Prazo: Four months
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Four months
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Costs to health care system of index participant during winter
Prazo: Four months
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Four months
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Self-reported quality of life for index participant during winter
Prazo: Four months
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Four months
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Respiratory health of other people living in household during winter
Prazo: Four months
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Four months
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Any changes in index participant baseline lung function
Prazo: course of study ( up to 18 months)
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course of study ( up to 18 months)
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Study withdrawals due to death or greater dependency
Prazo: course of study (up to 18 months)
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course of study (up to 18 months)
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Support person burden
Prazo: course of study (up to 18 months)
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course of study (up to 18 months)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Philippa L Howden-Chapman, PhD, University of Otago
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HRC08/072AR
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