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临床试验/NCT05416879
NCT05416879招募中不适用

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

Newcastle University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Time spent sedentary (measured in minutes per day) during a 7-day monitoring period

研究概览

简要总结

Heart Failure occurs when the heart's ability to pump blood is reduced. Heart failure can lead to symptoms of breathlessness, fatigue and ankle swelling, and result in health complications including damage to other organs (e.g. kidneys), reduced function and quality of life. Although the symptoms of heart failure are similar for men and women, there are sex differences. Lifestyle behaviours such as physical activity are important modifiable risk factor for heart failure. Women continue to be underrepresented in heart failure studies and treatment guidelines are male-derived due to these disparities in recruitment. The purpose of the present study is to evaluate the physical activity levels, sedentary behaviour, sleep and quality of life and understand the barriers and facilitators to these lifestyle behaviours in women newly diagnosed with heart failure.

详细描述

Background: Heart failure is a condition in which the heart has a reduced function to pump blood during exertion and often at rest. Although the symptoms for heart failure are similar for men and women, there are sex differences in the heart failure etiologies. The incidence of heart failure is greater in men versus women, especially in the younger age groups (45-54 years). However, it has been reported from 79 years old, women have a greater prevalence than men. This is associated with the age at diagnosis being 5 years older for women compared to men (79.6 vs. 74.8 years). Men are more likely to present with heart failure with reduced ejection fraction (HFrEF) whereas women are twice as likely to present with heart failure with preserved ejection fraction (HFpEF). Given their more complex medical profile, men have significantly higher healthcare costs versus women during the first year after diagnosis. The global COVID-19 pandemic has resulted in services and care for patients with heart failure being significantly affected. Our recent review highlighted that patients are continuing to avoid urgent care, which may result in advanced manifestations of cardiac dysfunction and worse prognosis.

Physical activity is an important modifiable risk factor in patients with chronic heart failure and is known to improve function and quality of life (QoL). Although several studies report physical activity in patients with chronic heart failure, it appears that no study has evaluated physical activity in women at the time of diagnosis of heart failure and evaluated these lifestyle behaviours by understanding the barriers and facilitators. Women are underrepresented in heart failure studies and treatment guidelines are male-derived due to these disparities in recruitment. Our research will directly address this by evaluating the physical activity levels, sedentary behaviour, sleep and QoL of women newly diagnosed with heart failure and understand the barriers and facilitators to these lifestyle behaviours at the time of diagnosis.

Aim and Objectives: The aim of the project is to provide evidence for the current lifestyle behaviors of women newly diagnosed with heart failure. The aim will be achieved through the following three objective: (1) assess the physical activity levels, sedentary behavior and sleep of women newly diagnosed with heart failure using objective assessment (2) evaluate the quality of life of women newly diagnosed with heart failure and (3) understand the barriers and facilitators of these lifestyle behaviors of women at the time of their heart failure diagnosis.

Methods/Design: Study Design: A prospective, single-centre, pilot study design will evaluate physical activity, sedentary behaviour, sleep and QoL of women newly diagnosed with heart failure who have been referred to secondary care for specialist review and have attended a heart failure diagnostic clinic at the Royal Victoria Infirmary, Newcastle-upon-Tyne.

Recruitment procedures: Participants will be identified from the Heart Failure Diagnostic Clinics run by Drs MacGowan and Bailey who are part of the research study team and play a vital role in participant recruitment. An information sheet will be given to all patients (women only) after they have received their diagnosis at the diagnostic clinic appointment. A member of the research study team will attend the Heart Failure Diagnostic Clinics to provide a participant information sheet to eligible patients. The research study team will have an honorary contract with the Newcastle upon Tyne Hospital and sufficient level of competence and permission to assess patients' medical records using computerised system in place. The patient will be given at least 48 hours to read through the participant information sheet. A member of the research team will contact the patient via telephone call to see if they are happy to participate in the study. Research will seek informed and voluntary consent from the participant. A consent form will be attached to the participant information sheet for the patient to complete and return to the research study team via a pre-paid envelope. Consent forms will be signed by the participant and countersigned by a member of the research study team.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Time spent sedentary (measured in minutes per day) during a 7-day monitoring period

时间窗: 7-day at the time of diagnosis

7-day objective assessment using Actigraph GT3X+BT accelerometry at the time of diagnosis

Number of steps per day during a 7-day monitoring period

时间窗: 7-day at the time of diagnosis

7-day objective assessment using Actigraph GT3X+BT accelerometry at the time of diagnosis

Intensity of physical activity (light physical activity, measured in minutes per day) during a 7-day monitoring period

时间窗: 7-day at the time of diagnosis

7-day objective assessment using Actigraph GT3X+BT accelerometry at the time of diagnosis

Intensity of physical activity (moderate physical activity, measured in minutes per day) during a 7-day monitoring period

时间窗: 7-day at the time of diagnosis

7-day objective assessment using Actigraph GT3X+BT accelerometry at the time of diagnosis

Intensity of physical activity (vigorous physical activity, measured in minutes per day) during a 7-day monitoring period

时间窗: 7-day at the time of diagnosis

7-day objective assessment using Actigraph GT3X+BT accelerometry at the time of diagnosis

Sleep duration (measured in minutes per day) during a 7-day monitoring period

时间窗: 7-day at the time of diagnosis

7-day objective assessment using Actigraph GT3X+BT accelerometry at the time of diagnosis

Change in Baseline Minnesota Living with Heart Failure Questionnaire at 3 months

时间窗: 3 months

A 21-item questionnaire. A 5-point Likert scale used for each question. The questions are summed and the minimum and maximum values are 0-105. A higher score represents a worse health-related quality of life.

Patient's perceptions of physical activity, sedentary behaviour and quality of life

时间窗: 60 minutes

A semi-structured interview will explore the barriers and opportunities of past, present and future physical activity, sedentary behaviour and quality of life at the time of diagnosis

Change in Baseline 36-Item Short Form Survey Instrument at 3 months

时间窗: 3 months

A 36-item survey, which includes eight health concepts (physical functioning (10 items), role limitations due to physical health (4 items), role limitations due to emotional problems (3 items), energy/fatigue (4 items), emotional well-being (5 items), social functioning (2 items), pain (2 items) and general health (5 items). Each item is scored 0-100. A higher score represents a better health-related quality of life.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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