Article Text
Abstract
Objective To examine whether providing thermal clothing improved the health of patients with heart failure during winter.
Design Parallel group randomised controlled trial.
Setting Large public hospital in Brisbane during winter 2016.
Participants 91 patients with systolic or diastolic heart failure who were over 50 years old.
Intervention 47 patients were randomised to receive thermal clothes (socks, top and hat) and 44 received usual care. Patients could not be blinded to their randomised group. All patients’ data were available for the primary outcome which was collected blind to randomised group.
Main outcome measures The primary outcome was the mean number of days in hospital during winter. Secondary outcomes included quality of life and sleep, and blood tests were collected for cardiovascular risk factors. Participants completed clothing diaries in midwinter which were used to estimate their overall clothing insulation using the ‘clo’. Monitors inside the participants’ homes recorded indoor temperatures throughout winter.
Results The mean number of days in hospital during winter was 4.2 in the usual care group and 3.0 in the thermal clothing group (mean difference –1.2 days, 95% CI –4.8 to 2.5 days). Most participants (85%) in the thermal clothing group reported using the thermals. There was an increase in overall clothing insulation at night in the thermal clothing group (mean difference 0.13 clo, 95% CI 0.03 to 0.23). Most participants in both groups did not wear sufficient clothing (defined as a clo below 1) and regularly experienced indoor temperatures below 18°C during midwinter.
Conclusions There was no clear statistical improvement in health in the thermal clothing group. Efforts to improve health during winter may need to focus on passive interventions such as home insulation rather than interventions that target behaviour change.
Trial registration number ACTRN12615001023549; Results.
- heart failure
- preventive medicine
- sleep medicine
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
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Footnotes
Contributors AGB conceived the study and led the application for funding. AGB designed the study with input from DP, JFF and IS. DP and AB oversaw patient recruitment. AB collected the baseline data. AGB ran the statistical analysis and wrote the first draft. All authors provided input on the first draft. AGB is the guarantor.
Funding This study was funded by the Heart Foundation of Australia Vanguard (Grant number 100568). Adrian Barnett is supported by an NHMRC Senior Research Fellowship (APP1117784).
Competing interests None declared.
Ethics approval The Prince Charles Hospital Human Research Ethics Committee.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The full de-identified dataset and statistical code are available on figshare https://figshare.com/articles/Thermal_clothing_clinical_trial/4649231
. We welcome re-use and re-analysis of the data. The secondary outcome of GP visits could not be shared due to restrictions by the Department of Human Services.