Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000081718
Ethics application status
Approved
Date submitted
21/12/2012
Date registered
22/01/2013
Date last updated
22/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Warm Homes for Elder New Zealanders - Warm Hearts
Scientific title
Effect of a home heating voucher on the cardiac functioning of older people with Chronic Obstructive Pulmonary Disease
Secondary ID [1] 281684 0
Nil known
Universal Trial Number (UTN)
U111111358737
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 287969 0
Cardiovascular disease 287970 0
Condition category
Condition code
Public Health 288371 288371 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A NZ$500 payment into the electricity account of the household of the participant, the payment made at the start of winter. The participants will be given a brochure telling them how much electricity they could buy with the voucher, and be encouraged to use the electricity for additional winter heating. The period of expected behaviour change is the winter months, however we are also measuring during the summer months to gain a personal baseline.
Intervention code [1] 286217 0
Treatment: Other
Intervention code [2] 286218 0
Prevention
Intervention code [3] 286219 0
Behaviour
Comparator / control treatment
No treatment in the first winter. (During the second winter in the study the control group will receive the payment)
Control group
Active

Outcomes
Primary outcome [1] 288517 0
Cardiac autonomic balance as assessed by measurements of the beat-to-beat changes in heart rate recorded over 24 hours. This will be measured by a 24-hour Holter monitor fitted during late winter and late summer.
Timepoint [1] 288517 0
Changes between the late winter measurement and prior late summer measurement
Primary outcome [2] 288518 0
Cardiovascular blood markers (Pro NT-BNP, for heart failure and severity of heart failure; hsCRP, for inflammatory state; and hsTnT, a marker of cardiac necrosis)
Timepoint [2] 288518 0
Changes between the late winter reading and the prior late summer reading
Secondary outcome [1] 300429 0
Dwelling warmth, as measured by the installed dataloggers.
Timepoint [1] 300429 0
Feburary/March (late summer) and July/August (late winter)
Secondary outcome [2] 300430 0
Self reported well-being as measured by questionnaire asked during the fitting of the Holter monitor. (The questionnaire will be based on those asked during previous studies)
Timepoint [2] 300430 0
Differences between the late summer and late winter periods
Secondary outcome [3] 300431 0
Spirometry - FEV1, FVC
Timepoint [3] 300431 0
Comparing the late winter reading to the late summer reading

Eligibility
Key inclusion criteria
Enrollment in the prior Warm Homes for Elder New Zealanders Study.
Minimum age
47 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No longer living in the community. Inability to communicate.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants are invited to participate and enroll. After the first summer data collection is carried out, a statistican external to the study team will carry out the randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The statistician will be given a list of study ID codes, (s)he will then assign a random number to each ID code. The participants assigned the lowest 1/2 of the random numbers will be assigned to the early intervention group, and the others to the late intervention group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Features of both 'parallel' and 'crossover'. The "early" and "late" groups receive the same intervention, with the "late" group delayed by a year, however due to the possibility of the intervention changing later behaviour this is not a standard crossover design. Neither is it a standard parallel design, as the two groups receive the same intervention
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/01/2013
Actual
Date of last participant enrolment
Anticipated
15/02/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 4758 0
New Zealand
State/province [1] 4758 0
Wellington

Funding & Sponsors
Funding source category [1] 286473 0
Government body
Name [1] 286473 0
Health Research Council
Country [1] 286473 0
New Zealand
Primary sponsor type
University
Name
University of Otago,
Address
Wellington campus
23a Mein St
Newtown
po box 7343 Wellington South 6242
Country
New Zealand
Secondary sponsor category [1] 285263 0
None
Name [1] 285263 0
none
Address [1] 285263 0
Country [1] 285263 0
Other collaborator category [1] 277227 0
None
Name [1] 277227 0
none
Address [1] 277227 0
none
Country [1] 277227 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288550 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 288550 0
Health and Disability Ethics Committees
1 The Terrace
PO Box 5013
Wellington
6011
Ethics committee country [1] 288550 0
New Zealand
Date submitted for ethics approval [1] 288550 0
31/10/2012
Approval date [1] 288550 0
16/11/2012
Ethics approval number [1] 288550 0
12/CEN/61

Summary
Brief summary
The primary aim of Warm Hearts is to investigate the impact of variations in indoor temperatures on the cardiac functioning of older people with COPD.
Our hypothesis is that cold indoor temperatures impair cardiac functioning. This increase impairment will be associated with an increase in oxygen demand and blood pressure. In people with reduced cardiovascular reserve, these effects may increase the risk of caridac symptoms or heart attacks and progression of heart failure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36622 0
Prof Philippa Howden-Chapman
Address 36622 0
He Kainga Oranga / Housing and Health Research Programme
Department of Public Health
University of Otago, Wellington
PO Box 7343
Wellington South 6242
Country 36622 0
New Zealand
Phone 36622 0
+ 64 4 3855541 x6047
Fax 36622 0
Email 36622 0
[email protected]
Contact person for public queries
Name 36623 0
Ms Helen Viggers
Address 36623 0
He Kainga Oranga / Housing and Health Research Programme
Department of Public Health
University of Otago, Wellington
PO Box 7343
Wellington South 6242
Country 36623 0
New Zealand
Phone 36623 0
+64 4 3855541 x6847
Fax 36623 0
Email 36623 0
[email protected]
Contact person for scientific queries
Name 36624 0
Ms Helen Viggers
Address 36624 0
He Kainga Oranga / Housing and Health Research Programme
Department of Public Health
University of Otago, Wellington
PO Box 7343
Wellington South 6242
Country 36624 0
New Zealand
Phone 36624 0
+64 4 3855541 x6847
Fax 36624 0
Email 36624 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.