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

Phase 3

Completed

• Conditions: Heart Failure; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12615001023549
• Lead Sponsor: Queensland University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber 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 Measures

Name	Time	Method
Quality of life using EQ-5D[Midwinter (July 2016) and the end of winter (Sep/Oct 2016)];Sleep quality using the Pittsburgh sleep questionnaire[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];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];Systolic blood pressure using sphygmomanometer[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)];Cholesterol by blood sample analysis[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)];c-reactive protein by blood sample analysis[Midwinter (July 2016) and the end of winter (Sep/Oct 2016)]