- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Christchurch, Nueva Zelanda
- Christchurch
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Wanganui, Nueva Zelanda
- Wanganui / Manawatu
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Wellington, Nueva Zelanda
- Wellington / Hutt/ Porirua
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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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Otro: 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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Moderate or severe exacerbations of COPD during winter for which hospitalisation, systemic corticosteroids and/or antibiotics are required to treat the exacerbation
Periodo de tiempo: Four months
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Four months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Severe exacerbations of COPD during winter for which hospitalisation is required to treat the exacerbation
Periodo de tiempo: 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
Periodo de tiempo: Four months
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Four months
|
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All-cause hospitalisation during winter
Periodo de tiempo: Four months
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Four months
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Temperature in the living and bedrooms during winter
Periodo de tiempo: Four months
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Four months
|
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Electricity usage during winter
Periodo de tiempo: Four months
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Four months
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Costs to health care system of index participant during winter
Periodo de tiempo: Four months
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Four months
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Self-reported quality of life for index participant during winter
Periodo de tiempo: Four months
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Four months
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Respiratory health of other people living in household during winter
Periodo de tiempo: Four months
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Four months
|
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Any changes in index participant baseline lung function
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HRC08/072AR
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