Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01627418
Other study ID # HRC08/072AR
Secondary ID
Status Completed
Phase N/A
First received August 2, 2011
Last updated June 15, 2015
Start date April 2009
Est. completion date February 2013

Study information

Verified date June 2015
Source University of Otago
Contact n/a
Is FDA regulated No
Health authority New Zealand: Health Research Council
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 522
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group 55 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
Energy Voucher
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.
No intervention : control arm
Do not receive the money or pamphlet in the initial study year

Locations

Country Name City State
New Zealand Christchurch Christchurch
New Zealand Wanganui / Manawatu Wanganui
New Zealand Wellington / Hutt/ Porirua Wellington

Sponsors (2)

Lead Sponsor Collaborator
University of Otago Health Research Council, New Zealand

Country where clinical trial is conducted

New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Moderate or severe exacerbations of COPD during winter for which hospitalisation, systemic corticosteroids and/or antibiotics are required to treat the exacerbation Four months No
Secondary Severe exacerbations of COPD during winter for which hospitalisation is required to treat the exacerbation Four months No
Secondary Moderate exacerbations of COPD during winter; which will be defined as requiring treatment with systemic corticosteroids and/or antibiotics Four months No
Secondary All-cause hospitalisation during winter Four months No
Secondary Temperature in the living and bedrooms during winter Four months No
Secondary Electricity usage during winter Four months No
Secondary Costs to health care system of index participant during winter Four months No
Secondary Self-reported quality of life for index participant during winter Four months No
Secondary Respiratory health of other people living in household during winter Four months No
Secondary Any changes in index participant baseline lung function course of study ( up to 18 months) No
Secondary Study withdrawals due to death or greater dependency course of study (up to 18 months) No
Secondary Support person burden course of study (up to 18 months) No
See also
  Status Clinical Trial Phase
Completed NCT05102305 - A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
Completed NCT01867762 - An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease Phase 2
Recruiting NCT05562037 - Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA N/A
Terminated NCT04921332 - Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD N/A
Completed NCT03089515 - Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust N/A
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT05552833 - Pulmonary Adaptive Responses to HIIT in COPD N/A
Recruiting NCT05835492 - A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
Recruiting NCT05631132 - May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases? N/A
Completed NCT03244137 - Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
Not yet recruiting NCT03282526 - Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease N/A
Completed NCT02546700 - A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD) Phase 2
Withdrawn NCT04446637 - Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD Phase 3
Completed NCT04535986 - A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD Phase 3
Recruiting NCT05865184 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Completed NCT03295474 - Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
Completed NCT03256695 - Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Withdrawn NCT04042168 - Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Phase 4
Completed NCT03414541 - Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease Phase 2
Completed NCT02552160 - DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy