Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04740489
Status:
UNKNOWN
Last Update Posted:
2021-02-05
First Post:
2021-01-29
Brief Title:
The Impact of Covid-19 on Cardiac Rehabilitation Participants and Staff
Sponsor:
Ant Shepherd
Organization:
University of Portsmouth
Study Overview
Official Title:
A Pilot Study Examining Participants Psychosocial Health Physical Activity and Staff Experiences Is Adapted Home-based Phase 3 Cardiac Rehabilitation Feasible and Beneficial
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 eg heart attack angina valve disease The service helps to improve recovery rates through supporting patients with beneficial lifestyle changes eg 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 patients 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 staffs experiences implementing programme changes to assist in preparing for the future of CR post COVID 19
Cardiac rehabilitation CR is a vital service for individuals diagnosed and treated for cardiovascular disease eg heart attack angina valve disease The service helps to improve recovery rates through supporting patients with beneficial lifestyle changes eg 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 patients 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 staffs experiences implementing programme changes to assist in preparing for the future of CR post COVID 19
Detailed Description:
Cardiovascular disease CVD causes 179 million deaths globally each year an estimated 31 of all deaths worldwide Individuals diagnosed with CVD eg acute coronary syndrome are typically referred to cardiac rehabilitation CR following acute treatment eg 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 eg revascularisation Phase 2 is considered as early rehabilitation following patient discharge usually a period of 2-6 weeks home-based support eg 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 754 of participants receive group-based supervised programmes and only 88 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 eg 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 participants 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 eg 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 RCTs 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 eg 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 staffs experiences of adapted delivery
3 Determine the feasibility of an adapted home-based CR programme for routine clinical practice
The timescale of CR can be divided into 4 interlinked phases Phase 1 is marked by admission to hospital and acute care eg revascularisation Phase 2 is considered as early rehabilitation following patient discharge usually a period of 2-6 weeks home-based support eg 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 754 of participants receive group-based supervised programmes and only 88 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 eg 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 participants 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 eg 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 RCTs 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 eg 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 staffs experiences of adapted delivery
3 Determine the feasibility of an adapted home-based CR programme for routine clinical practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None