- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
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Christchurch, Nuova Zelanda
- Christchurch
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Wanganui, Nuova Zelanda
- Wanganui / Manawatu
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Wellington, Nuova Zelanda
- Wellington / Hutt/ Porirua
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
|
Altro: 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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Moderate or severe exacerbations of COPD during winter for which hospitalisation, systemic corticosteroids and/or antibiotics are required to treat the exacerbation
Lasso di tempo: Four months
|
Four months
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Severe exacerbations of COPD during winter for which hospitalisation is required to treat the exacerbation
Lasso di tempo: Four months
|
Four months
|
Moderate exacerbations of COPD during winter; which will be defined as requiring treatment with systemic corticosteroids and/or antibiotics
Lasso di tempo: Four months
|
Four months
|
All-cause hospitalisation during winter
Lasso di tempo: Four months
|
Four months
|
Temperature in the living and bedrooms during winter
Lasso di tempo: Four months
|
Four months
|
Electricity usage during winter
Lasso di tempo: Four months
|
Four months
|
Costs to health care system of index participant during winter
Lasso di tempo: Four months
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Four months
|
Self-reported quality of life for index participant during winter
Lasso di tempo: Four months
|
Four months
|
Respiratory health of other people living in household during winter
Lasso di tempo: Four months
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Four months
|
Any changes in index participant baseline lung function
Lasso di tempo: course of study ( up to 18 months)
|
course of study ( up to 18 months)
|
Study withdrawals due to death or greater dependency
Lasso di tempo: course of study (up to 18 months)
|
course of study (up to 18 months)
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Support person burden
Lasso di tempo: course of study (up to 18 months)
|
course of study (up to 18 months)
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Philippa L Howden-Chapman, PhD, University of Otago
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HRC08/072AR
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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