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临床试验/NCT04740489
NCT04740489Unknown不适用

A Pilot Study Examining Participants Psychosocial Health, Physical Activity and Staff Experiences: Is Adapted Home-based Phase 3 Cardiac Rehabilitation Feasible and Beneficial?

Ant Shepherd0 个研究点目标入组 30 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
主要终点
Psychosocial health and wellbeing

研究概览

简要总结

What are the experiences of staff and participants in phase 3 cardiac rehabilitation during the Covid-19 pandemic, and what impacts have adapted delivery had on participants' physical activity levels, mental health and well-being?

Cardiac rehabilitation (CR) is a vital service for individuals diagnosed and treated for cardiovascular disease (e.g., heart attack, angina, valve disease). The service helps to improve recovery rates through supporting patients with beneficial lifestyle changes (e.g., physical activity, healthy eating), and coping with emotional distress following a traumatic cardiac event. The environment in which CR is being delivered has changed in response to the Covid-19 pandemic, including remote working practices, and in some instances postponing of rehabilitation. Despite the public health rationale for such measures, it is essential to consider the impact of adapted services on patient's mental health and physical activity participation, and to consider staff experiences in using remote working regimes. The current study aims to recruit staff and patients from phase 3 cardiac rehabilitation across Hampshire Hospitals Foundation Trust to explore their experiences of adapted services through a mixed methods study design. Staff and patients will be interviewed over the phone to explore experiences and impacts of Covid-19 with their rich in-depth viewpoints and stories. In addition, during an 8 week period of rehabilitation, patients will be asked to report and record their physical activity levels with diaries and accelerometers (a wrist worn device measuring movement), record their resting blood pressure and heart rate, and complete questionnaires to assess changes in mental health. This study could help to understand the impact of the pandemic on cardiac patients recovery and on staff's experiences implementing programme changes to assist in preparing for the future of CR post COVID 19.

详细描述

Cardiovascular disease (CVD) causes 17.9 million deaths globally each year, an estimated 31% of all deaths worldwide. Individuals diagnosed with CVD (e.g., acute coronary syndrome) are typically referred to cardiac rehabilitation (CR) following acute treatment (e.g. percutaneous coronary intervention) to facilitate both physical and psychological recovery, as well as an absolute risk reduction in cardiovascular mortality.

The timescale of CR can be divided into 4 interlinked phases. Phase 1 is marked by admission to hospital and acute care (e.g., revascularisation). Phase 2 is considered as early rehabilitation following patient discharge, usually a period of 2-6 weeks home-based support (e.g., Heart Manual) depending on when a participant is considered fit enough to start a structured exercise programme. Phase 3 CR is a comprehensive outpatient programme, considered the core rehabilitation phase, in which participants receive structured exercise, health education, risk factor modification and psychological support. Upon discharge from clinically supervised phase 3 CR participants are generally signposted to long-term community based exercise classes (phase 4).

The current study will take place within a core phase 3 CR programme in the UK. According to the National Audit of CR, 75.4% of participants receive group-based supervised programmes, and only 8.8% of participants receive home-based services in the UK (BHF, 2019). Nevertheless, the environment in which CR is being delivered has dramatically changed in response to the COVID 19 pandemic. Staff have been redeployed to COVID units, limiting operative capabilities, and in some instances postponed rehabilitation. In the midst of this global crisis, The European Association of Preventive Cardiology recommended an increased patient turnover in CR, adoption of precautions during programmes (e.g., avoiding group exercises), shortening the programmes, and following participants with remote assessment. Despite the public health rationale for such measures, it is essential to consider the impact of adapted services on participant's psychosocial health and physical activity participation, and to consider staff experiences of adaptation 'on the fly' through remote working protocols.

An integral characteristic of group-based CR settings is a positive, supporting and inclusive climate that encourages participants to manage their emotions and illness perceptions to improve coping and recovery following a cardiac event . Currently, these interpersonal dynamics have dramatically altered with the shift to remote delivery of CR components (e.g., telephone, video, internet, and social media). Hence, some of the benefits of group and face to face rehabilitation have arguably been removed. In addition, participants are now having to cope with the added threat of catching COVID 19 and having to deal with some of the potentially distressing consequences of quarantine, such as post-traumatic stress symptoms, confusion and anger. Therefore, the CR work force needs to be resilient and innovative to support participants throughout the pandemic with home-based programmes and telemedicine.

Fortunately, there is an evidence base to suggest that home-based programmes, such as the "Heart Manual", are as effective as centre-based CR in improving clinical and health-related quality of life outcomes. Indeed, novel interventions, such as telehealth weight management, Rehabilitation EnAblement in Chronic Heart Failure (REACH-HF), and cardiac telerehabilitation interventions, such as REMOTE-CR, are effective alternatives to the 'gold standard' centre-based provision. However, these findings are typically based upon randomised controlled trials (RCT) and are rarely investigated within real-world clinical settings where the research to practice gap needs to be negotiated. Scaling up RCT's and implementing novel remote programmes into CR promptly and effectively during the current pandemic could be a challenging process impacted by attitudes towards change, resources available, expertise, time, and competing priorities. Hence, it is important to assess and understand the real-world patient outcomes (e.g., physical activity participation, psychosocial and physical health) and the complexity of employing adapted CR services during the Covid-19 pandemic, including the barriers and facilitators to such implementation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Aged 18 years or over
  • Staff and participants participating in Phase 3 CR
  • Able to give informed consent
  • Willing and able to undertake the interview, diary, questionnaire and accelerometer processes

排除标准

  • Aged <18 years
  • Not participating in Phase 3 CR
  • Any individuals who are unable to represent their own interests or are particularly susceptible to coercion (vulnerable individuals), and are therefore unable to give informed consent
  • If individuals have difficulties in adequately understanding written or verbal information in English, as the study doesn't have funding for a translator or interpreter

结局指标

主要结局

Psychosocial health and wellbeing

时间窗: During qualitative interviews (post week 5).

Semi structured interviews

次要结局

  • Blood pressure(Week 1, 4 and 8 of rehabilitation)
  • Physical activity(Week 1, 4 and 8 of rehabilitation)
  • Heart rate(Week 1, 4 and 8 of rehabilitation)
  • Acceptability to Participants(During qualitative interviews after the intervention has ended (post week 5).)
  • Feasible to Participants(During qualitative interviews after the intervention has ended (post week 5).)
  • Loneliness(Week 1, 4 and 8 of rehabilitation)
  • Disease management(Week 1, 4 and 8 of rehabilitation)

研究者

发起方
Ant Shepherd
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ant Shepherd

Senior Lecturer in Physical Activity, Exercise and Health

University of Portsmouth

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