Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01627418




Registration number
NCT01627418
Ethics application status
Date submitted
2/08/2011
Date registered
25/06/2012
Date last updated
17/06/2015

Titles & IDs
Public title
Warm Homes for Elder New Zealanders
Scientific title
Warm Homes for Elder New Zealanders: a Community Trial of People With COPD
Secondary ID [1] 0 0
HRC08/072AR
Universal Trial Number (UTN)
Trial acronym
WHEZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Energy Voucher
BEHAVIORAL - No intervention : control arm

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.

Other: 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.


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.

BEHAVIORAL: No intervention : control arm
Do not receive the money or pamphlet in the initial study year
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Moderate or severe exacerbations of COPD during winter for which hospitalisation, systemic corticosteroids and/or antibiotics are required to treat the exacerbation
Timepoint [1] 0 0
Four months
Secondary outcome [1] 0 0
Severe exacerbations of COPD during winter for which hospitalisation is required to treat the exacerbation
Timepoint [1] 0 0
Four months
Secondary outcome [2] 0 0
Moderate exacerbations of COPD during winter; which will be defined as requiring treatment with systemic corticosteroids and/or antibiotics
Timepoint [2] 0 0
Four months
Secondary outcome [3] 0 0
All-cause hospitalisation during winter
Timepoint [3] 0 0
Four months
Secondary outcome [4] 0 0
Temperature in the living and bedrooms during winter
Timepoint [4] 0 0
Four months
Secondary outcome [5] 0 0
Electricity usage during winter
Timepoint [5] 0 0
Four months
Secondary outcome [6] 0 0
Costs to health care system of index participant during winter
Timepoint [6] 0 0
Four months
Secondary outcome [7] 0 0
Self-reported quality of life for index participant during winter
Timepoint [7] 0 0
Four months
Secondary outcome [8] 0 0
Respiratory health of other people living in household during winter
Timepoint [8] 0 0
Four months
Secondary outcome [9] 0 0
Any changes in index participant baseline lung function
Timepoint [9] 0 0
course of study ( up to 18 months)
Secondary outcome [10] 0 0
Study withdrawals due to death or greater dependency
Timepoint [10] 0 0
course of study (up to 18 months)
Secondary outcome [11] 0 0
Support person burden
Timepoint [11] 0 0
course of study (up to 18 months)

Eligibility
Key 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
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2013
Sample size
Target
Accrual to date
Final
522
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch
Country [2] 0 0
New Zealand
State/province [2] 0 0
Wanganui
Country [3] 0 0
New Zealand
State/province [3] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Other
Name
University of Otago
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Health Research Council, New Zealand
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Philippa L Howden-Chapman, PhD
Address 0 0
University of Otago
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01627418