Heart DiseasesNCT04740489
The Impact of Covid-19 on Cardiac Rehabilitation Participants and Staff
An observational study of Heart Diseases, run by Ant Shepherd.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Phase 3 Cardiac rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Service user participants are individuals treated for acute coronary syndromes (e.g., NSTEMI, STEMI), heart failure, valve disease, and ICD's. Staff participants will be recruited from members of a multidisciplinary team including; CR professionals including CR specialist nurses, physiotherapists and exercise practitioners.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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?
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.
Read the detailed 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:
- Assess the impact of adapted CR modalities in the UK on participants' physiological health, psychosocial health and physical activity behaviour
- Explore CR staff's experiences of adapted delivery
- Determine the feasibility of an adapted home-based CR programme for routine clinical practice
- Conditions
- Heart Diseases
- Being tested
- Phase 3 Cardiac rehabilitation
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase 3 Cardiac rehabilitationBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychosocial health and wellbeing
Semi structured interviews
Measured: During qualitative interviews (post week 5).
Secondary outcomes (8)
Acceptability to Participants
Qualitative interviews
Measured: During qualitative interviews after the intervention has ended (post week 5).
Feasible to Participants
Qualitative interviews
Measured: During qualitative interviews after the intervention has ended (post week 5).
Physical activity
Accelerometer
Measured: Week 1, 4 and 8 of rehabilitation
Loneliness
University of California, Los Angeles (UCLA) loneliness scale version 3 (minimum score 20 maximum of 80). Higher score signifies more loneliness
Measured: Week 1, 4 and 8 of rehabilitation
Heart rate
Beats per minute
Measured: Week 1, 4 and 8 of rehabilitation
Blood pressure
mmHg
Measured: Week 1, 4 and 8 of rehabilitation
Disease management
Patient activation measure (Questionnaire)
Measured: Week 1, 4 and 8 of rehabilitation
Disease management
The Cardiac Self-Efficacy (CSE) Scale. (minimum score 0 maximum of 52). Higher score indicates higher cardiac self-efficacy
Measured: Week 1, 4 and 8 of rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start1 Feb 2021 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ant Shepherd
- Sponsor type
- University, hospital or other
- Collaborators
- Hampshire Hospitals NHS Foundation Trust
- Responsible party
- Sponsor-investigator, Ant Shepherd, University of Portsmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740489
- Sponsor's protocol ID
- 005
- Status last verified
- Jan 2021
- First submitted
- 29 Jan 2021
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Physical data will be made available. Interview transcripts will not as participants could be identified.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT04740489
- Acronym / sponsor ID
- 005
- Conditions
- Heart Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ant ShepherdUniversity, hospital or other
- Collaborators
- Hampshire Hospitals NHS Foundation Trust
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- Assess the impact of adapted CR modalities in the UK on participants' physiological health, psychosocial health and physical activity behaviour
- Explore CR staff's experiences of adapted delivery
- Determine the feasibility of an adapted home-based CR programme for routine clinical practice
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Service user participants are individuals treated for acute coronary syndromes (e.g., NSTEMI, STEMI), heart failure, valve disease, and ICD's. Staff participants will be recruited from members of a multidisciplinary team including; CR professionals including CR specialist nurses, physiotherapists and exercise practitioners.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phase 3 Cardiac rehabilitationPhase 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. | Behavioural | – |
Primary outcome
Psychosocial health and wellbeing
Time frame: During qualitative interviews (post week 5).
Semi structured interviews
8 secondary outcomes
Acceptability to Participants
Time frame: During qualitative interviews after the intervention has ended (post week 5).
Feasible to Participants
Time frame: During qualitative interviews after the intervention has ended (post week 5).
Physical activity
Time frame: Week 1, 4 and 8 of rehabilitation
Loneliness
Time frame: Week 1, 4 and 8 of rehabilitation
Heart rate
Time frame: Week 1, 4 and 8 of rehabilitation
Blood pressure
Time frame: Week 1, 4 and 8 of rehabilitation
Disease management
Time frame: Week 1, 4 and 8 of rehabilitation
Disease management
Time frame: Week 1, 4 and 8 of rehabilitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Individual participant dataSharing planned: Undecided. Physical data will be made available. Interview transcripts will not as participants could be identified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases, run by Ant Shepherd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samantha J Meredith, PhD (0239284 ext. 5194, samantha.meredith@port.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychosocial health and wellbeing (time frame: During qualitative interviews (post week 5).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.