Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04740489 |
| Other study ID # |
005 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2021 |
| Est. completion date |
June 1, 2022 |
Study information
| Verified date |
January 2021 |
| Source |
University of Portsmouth |
| Contact |
Samantha J Meredith, PhD |
| Phone |
0239284 |
| Email |
samantha.meredith[@]port.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.
The purpose of this pilot study is to obtain quantitative and qualitative data to:
1. Assess the impact of adapted CR modalities in the UK on participants' physiological
health, psychosocial health and physical activity behaviour
2. Explore CR staff's experiences of adapted delivery
3. Determine the feasibility of an adapted home-based CR programme for routine clinical
practice
