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Trial registered on ANZCTR


Trial ID
ACTRN12612000378820
Ethics application status
Approved
Date submitted
30/03/2012
Date registered
3/04/2012
Date last updated
9/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of thermals to prevent heart failure
Scientific title
A randomised controlled trial of thermals to prevent further heart failure hospitalisations in heart failure patients
Secondary ID [1] 280253 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart failure 286206 0
Condition category
Condition code
Cardiovascular 286417 286417 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a two arm trial using a 1:1 ratio. Patients in the treatment arm will receive: two pairs of thermal hats and tops, a digital thermometer (with a large display and a battery fitted), and a laminated instruction sheet on when they should wear the thermals. The patients are asked to put the digital thermometer by their bed to help them judge when to wear the thermals. The instruction sheet recommends they wear the thermals when:
1. The indoor temperature is below 18 degrees C when they wake up (for day wear).
2. The indoor temperature is below 18 degrees C degrees when they go to bed (for night wear).
3. Before they go outside for 10 minutes or more and the outdoor temperature is below 18 degrees C.
The instruction sheet recommends they remove the thermals (hat and/or top) if they feel hot or sweaty.

The patients will be recruited at the start of winter (May 2012) and followed-up in the spring (October 2012).

This is a pilot study.
Intervention code [1] 284600 0
Prevention
Comparator / control treatment
Patients in the control arm will receive the usual care, as they will get no extra clothes or instructions.
Control group
Active

Outcomes
Primary outcome [1] 286865 0
Number of days in hospital from a retrospective review of the patients records at the end of winter.
Timepoint [1] 286865 0
May to October 2012
Secondary outcome [1] 296836 0
Self-rated health using the single SF-36 questionnaire ("In general, would you say your current health is", 5 responses from "Excellent" to "Poor"). This will be collected via a telephone follow-up in October 2012.
Timepoint [1] 296836 0
1/10/2012
Secondary outcome [2] 296837 0
Self-reported number of GP visits in the last month. This will be collected via a telephone follow-up in October 2012.
Timepoint [2] 296837 0
1/10/2012

Eligibility
Key inclusion criteria
1. Patient has signed and understood the informed consent form
2. Suffered a heart failure event in the systolic dysfunction category in the last month
3. Living in Queensland
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnant women
2. People living in a residential care facility
3. People with incontinence
4. People unable to give consent

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)
The patients will be recruited via the cardiology clinic at The Prince Charles Hospital. After patients have consented the research nurse will open a sealed opaque envelope containing the treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation in a 1:1 ratio. The list will be generated using the R software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5252 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 5168 0
4032

Funding & Sponsors
Funding source category [1] 285016 0
University
Name [1] 285016 0
Queensland University of Technology
Address [1] 285016 0
60 Musk Avenue, Kelvin Grove, QLD 4053
Country [1] 285016 0
Australia
Primary sponsor type
Hospital
Name
The Prince Charles Hospital
Address
Rode Road, Chermside, Queensland 4032
Country
Australia
Secondary sponsor category [1] 283879 0
Commercial sector/Industry
Name [1] 283879 0
Wilderness Wear Aust. Pty Ltd
Address [1] 283879 0
PO Box 2253, Kew, Victoria 3101
Country [1] 283879 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287018 0
The Prince Charles Hospital Ethics Committee
Ethics committee address [1] 287018 0
Ethics committee country [1] 287018 0
Australia
Date submitted for ethics approval [1] 287018 0
26/04/2012
Approval date [1] 287018 0
20/06/2012
Ethics approval number [1] 287018 0
HREC/12/QPCH/79

Summary
Brief summary
Rates of heart failure hospitalisations and deaths in Brisbane increase greatly in winter and in cold weather. Many events could be avoided if people took better measures to protect themselves against the outdoor temperature. A simple and cheap protective measure is thermal clothing. We will randomise patients who have a heart failure event at the start of winter to either a control group, or a treatment group who will receive two pairs of thermal tops and hats. At the end of winter we will retrospectively examine their hospital records to compare the length of time spent in hospital. We will contact all participants by phone at the end of winter to ask them about their self-rated health and their compliance with the thermals. This is a pilot study of 100 patients that will lead to a larger study if the results are promising.
Trial website
Nil
Trial related presentations / publications
The benefits of thermal clothing during winter in patients with heart failure: a pilot randomised controlled trial. BMJ Open 2013;3:e002799 doi:10.1136/bmjopen-2013-002799
Public notes

Contacts
Principal investigator
Name 34007 0
A/Prof Adrian Barnett
Address 34007 0
Queensland University of Technology, 60 Musk Avenue, Kelvin Grove, QLD 4053
Country 34007 0
Australia
Phone 34007 0
61731386010
Fax 34007 0
Email 34007 0
a.barnett@qut.edu.au
Contact person for public queries
Name 17254 0
A/Prof Adrian Barnett
Address 17254 0
Queensland University of Technology
60 Musk Avenue
Kelvin Grove
QLD 4053
Country 17254 0
Australia
Phone 17254 0
+61-7-3138 6010
Fax 17254 0
+61-7-3138 6030
Email 17254 0
a.barnett@qut.edu.au
Contact person for scientific queries
Name 8182 0
A/Prof Adrian Barnett
Address 8182 0
Queensland University of Technology
60 Musk Avenue
Kelvin Grove
QLD 4053
Country 8182 0
Australia
Phone 8182 0
+61-7-3138 6010
Fax 8182 0
Email 8182 0
a.barnett@qut.edu.au