Using thermal clothing to reduce heart failure morbidity during winter: a randomised controlled trial

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615001023549
• Date of registration: 01/10/2015
• Prospective Registration: Yes
• Primary sponsor: Queensland University of Technology
• Public title: Using thermal clothing to reduce heart failure morbidity during winter: a randomised controlled trial
• Scientific title: Efficacy of thermal clothing in reducing hospitalisations during winter for heart failure patients
• Date of first enrolment: 05/04/2016
• Target sample size: 120
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615001023549.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 3

Countries of recruitment

Australia

Contacts

• Name: A/Prof Adrian Barnett

• Name: A/Prof Adrian Barnett

Key inclusion & exclusion criteria

Inclusion criteria: Have a diagnosis of either systolic or diastolic heart failure
Exclusion criteria: 1. Are pregnant (highly unlikely).
2. A serious co-morbidity (e.g., cancer) or a serious physical impairment that prevents the participant from dressing themselves.
3. Live in a residential care facility.
4. Are unable to give informed consent.
5. Were involved in our previous pilot.

Age minimum: 50 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Heart Failure;
Heart Failure

Cardiovascular - Other cardiovascular diseases

Intervention(s)

Thermal clothing: two thermal tops, two pairs of thermal socks, one thermal hat.

A large display indoor temperature monitor to be placed inside the home.

A single A4 advisory sheet on when to wear the thermals, with the recommendation to wear the thermals in the following circumstances:
1. If the indoor temperature is below 18.0 degrees C when you wake up, then wear the thermals under your normal clothes during the day.
2. If the indoor temperature is below 18.0 degrees C degrees just before you go to bed, then wear the thermals in bed.
3. If you are going outside for 10 minutes or more and the outdoor temperature is below 18.0 degrees C, then wear the thermals under your normal clothes.

The intervention period is from 1 May 2016 to 30 September 2016 (5 months).

Adherence to the thermals will be monitored using a self-completed clothing diary for one week during July 2016.

Primary Outcome(s)

Number of days in hospital using combined data on private hospital admissions from Medicare data and public hospital admissions from the Queensland Hospital Admitted Patient Data Collection.[1 May 2016 to 30 September 2016]

Secondary Outcome(s)

Cholesterol by blood sample analysis[Midwinter (July 2016) and the end of winter (Sep/Oct 2016)]

Number of GP visits during winter using Medicare data [1 May 2016 to 30 September 2016]

Systolic blood pressure using sphygmomanometer[Midwinter (July 2016) and the end of winter (Sep/Oct 2016)]

Fibrinogen by blood sample analysis[Midwinter (July 2016) and the end of winter (Sep/Oct 2016)]

Blood viscosity by blood sample analysis[Midwinter (July 2016) and the end of winter (Sep/Oct 2016)]

Quality of life using EQ-5D[Midwinter (July 2016) and the end of winter (Sep/Oct 2016)]

c-reactive protein by blood sample analysis[Midwinter (July 2016) and the end of winter (Sep/Oct 2016)]

Overall healthcare usage using a combination of: i) Medicare data, ii) the Queensland Emergency Department Information System, and iii) the Queensland Hospital Admitted Patient Data Collection[1 May 2016 to 30 September 2016]

Sleep quality using the Pittsburgh sleep questionnaire[Midwinter (July 2016) and the end of winter (Sep/Oct 2016)]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

The Heart Foundation

Secondary Sponsor(s)

The Prince Charles Hospital

Ethics review

Status: Approved
Approval date:
Contact:

Human Research Ethics Committee Metro North Hospital and Health Service