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A randomised controlled trial of thermals to prevent heart failure

A randomised controlled trial of thermals to prevent further heart failure hospitalisations in heart failure patients

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000378820
Acronym
Nil
Enrollment
55
Registered
2012-04-03
Start date
2012-06-21
Completion date
2012-07-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

The Prince Charles Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

1. Pregnant women 2. People living in a residential care facility 3. People with incontinence 4. People unable to give consent

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 23, 2026