The Impact of Covid-19 on Cardiac Rehabilitation Participants and Staff

February 4, 2021 updated by: Ant Shepherd

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Psychosocial health and wellbeing
Time Frame: During qualitative interviews (post week 5).
Semi structured interviews
During qualitative interviews (post week 5).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acceptability to Participants
Time Frame: During qualitative interviews after the intervention has ended (post week 5).
Qualitative interviews
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).
Qualitative interviews
During qualitative interviews after the intervention has ended (post week 5).
Physical activity
Time Frame: Week 1, 4 and 8 of rehabilitation
Accelerometer
Week 1, 4 and 8 of rehabilitation
Loneliness
Time Frame: Week 1, 4 and 8 of rehabilitation
University of California, Los Angeles (UCLA) loneliness scale version 3 (minimum score 20 maximum of 80). Higher score signifies more loneliness
Week 1, 4 and 8 of rehabilitation
Heart rate
Time Frame: Week 1, 4 and 8 of rehabilitation
Beats per minute
Week 1, 4 and 8 of rehabilitation
Blood pressure
Time Frame: Week 1, 4 and 8 of rehabilitation
mmHg
Week 1, 4 and 8 of rehabilitation
Disease management
Time Frame: Week 1, 4 and 8 of rehabilitation
Patient activation measure (Questionnaire)
Week 1, 4 and 8 of rehabilitation
Disease management
Time Frame: Week 1, 4 and 8 of rehabilitation
The Cardiac Self-Efficacy (CSE) Scale. (minimum score 0 maximum of 52). Higher score indicates higher cardiac self-efficacy
Week 1, 4 and 8 of rehabilitation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ant Shepherd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hampshire Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Physical data will be made available. Interview transcripts will not as participants could be identified.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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