Examining lifestyle behaviors in women newly diagnosed with heart failure

Lifestyle Behaviours of Women Newly Diagnosed With Heart Failure: A Quantitative and Qualitative Approach

This study looks at the daily habits and challenges of women who have just been diagnosed with heart failure to better understand how these factors affect their health and well-being.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Newcastle University (Academic / other)
• Locations: 1 site (Newcastle upon Tyne)
• Trial ID: NCT05416879 on ClinicalTrials.gov

What this trial studies

This observational study focuses on understanding the lifestyle behaviors of women who have recently been diagnosed with heart failure. It aims to evaluate their physical activity levels, sedentary behavior, sleep patterns, and quality of life, while also identifying barriers and facilitators to these behaviors. The study will utilize the Actigraph GT3X+BT device for monitoring physical activity and may include optional semi-structured interviews for deeper insights. By addressing the unique experiences of women in this demographic, the study seeks to fill a gap in heart failure research that has historically underrepresented female patients.

Who should consider this trial

Good fit: Ideal candidates for this study are adult women who have recently received a diagnosis of heart failure and can perform daily activities independently.

Not a fit: Patients who are male or those with severe symptoms requiring urgent medical attention will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies and tailored interventions for women with heart failure, enhancing their quality of life.

How similar studies have performed: While there have been studies on physical activity in heart failure patients, this specific focus on newly diagnosed women represents a novel approach.

Eligibility criteria

Inclusion Criteria:

* Adult women with a new diagnosis of heart failure after referral to the RVI Heart Failure Diagnostic Clinic;
* Able to walk and perform activities of daily living independently;
* New York Heart Association functional class II-IV;
* Willingness to undertake physical activity monitoring;
* Willingness to participate in a semi-structured interview (this is optional and the participant will be able to participate in the study if they choose not to take part in the interview);
* Ability to read, write and converse in English without the support of an interpreter;
* Able to provide written informed consent.

Exclusion Criteria:

* Male;
* Already diagnosed with heart failure;
* Presented with severe symptoms requiring urgent assessment and stabilisation (e.g. breathless at rest, hypotension, confusion);
* Major co-morbidity or other alternative diagnoses of no obvious acute and self-limiting cause (e.g. malignancy, severe respiratory disease, mental health problem);
* Severe physical disability preventing them to function independently;
* Clinically unstable with recent changes in medication;
* Unable to provide informed consent.

Where this trial is running

Newcastle upon Tyne

• Newcastle upon Tyne Hospitals NHS Foundation Trust — Newcastle upon Tyne, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Sarah Charman, PhD

Conditions Heart Failure