Clinical trial NCT04781699: Optimising Secondary Prevention and Quality of Life in Early Cardiac Rehabilitation
Official title: Optimising Secondary Prevention and Quality of Life in Early Cardiac Rehabilitation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Diseases
Coronary Artery Disease
Myocardial Infarction
Acute Coronary Syndrome
Coronary Heart Disease
Heart Failure
Keywords: Cardiac Rehabilitation
Secondary Prevention
Medication Adherence
Smoking Cessation
Healthy diet
Lifestyle
Exercise
Quality of life
Lead sponsor: Sheffield Hallam University
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Sheffield Teaching Hospitals NHS Foundation Trust
name: Royal Brompton & Harefield NHS Foundation Trust
name: Northumbria Healthcare NHS Foundation Trust
name: NHS Ayrshire and Arran
name: Belfast Health and Social Care Trust
name: Aneurin Bevan University Health Board
First posted: 2021-03-04
Enrollment: 498
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include patients and health care professionals across six CR sites across the UK who currently delivers comprehensive early CR. Each site will provide access to patients and providers with lived experience of the core components and behaviour changes associated with CR adherence. A local Principal Investigator has been identified at each site to oversee the local conduct of the study protocol and facilitate participant recruitment. A purposive sampling approach for the qualitative interveiws will be employed to ensure that participants represent a range of demographic backgrounds including ethnicity, socioeconomic group, cardiac diagnosis and length of engagement with CR.

Brief summary: The primary aim of this research is to explore the adherence and drop-out from early cardiac rehabilitation (CR), to inform interventions to support patient's adherence to CR and facilitate maintenance. The secondary aim is to understand which aspects of CR are essential for improving health-related quality of life in the short and long-term. This research will comprise four stages adopting a mixed-methods, quasi-experimental, repeated measures design.

Detailed description: This study will explore the attitudes of patients and healthcare practitioners towards the components of CR (diet, smoking, and medication) and their relationship with improving patients' perceived health and wellbeing. We will apply user-centred approaches by working with patients and other stakeholders to develop the best solutions that help patients to adhere to relevant health behaviour changes. The proposed study will use a mix of surveys and interviews. This will conclude with a two-day workshop with patients and health care professionals to come up with recommendations for improving adherence to CR.

Stage 1: A bespoke survey has been designed to examine the perceptions of patients and health care professionals. The survey will include questions around, CR referral, uptake and adherence rates. Factors that hinder and improve attendance to CR will be explored. Surveys will be distributed amongst CR patients across six centres in the United Kingdom: Sheffield, London, North of England, Scotland, Wales, and Northern Ireland. The aim is to collect survey responses from 498 patients.

Stage 2: Qualitative interviews will be carried out with both patients and professionals. Topics will include factors that improve or hinder attendance and completion of CR. In addition, factors in CR which assist with improving quality of life will be explored. This will provide a more in-depth understanding of challenges to attendance identified in study 1. Up to 10 patients from each site will be interviewed, plus up to 20 health care professionals across all sites.

Stage 3: Up to 30 participants recruited across regions will be invited to take part in a two-day workshop. The two-day co-design workshop will involve patients, clinicians, CR providers, and researchers. The aim is to develop recommendations and approaches to improving attendance and completion of CR. This will include improvements to existing CR.

Study Conduct, Participant identification, inclusion, and exclusion

Each of the six sites currently delivers comprehensive early CR and provides access to patients and providers with lived experience of the core components and behaviour changes associated with CR adherence. A local principal investigator who is responsible for the leadership of a research study has been identified at each site to oversee conduct of the study protocol and facilitate participant recruitment. Participants will represent a range of demographic backgrounds including ethnicity, socioeconomic group, cardiac diagnosis and length of engagement with CR. Recruitment to interviews will stop when no new themes are being identified from the interviews (data saturation).

Healthcare professionals meeting our inclusion criteria will be approached directly, by the principal investigator at each study site. People interested in the study will be given an information sheet, and a minimum of 24 hours to consider study information before recruitment. Patients will be identified and invited to take part in the qualitative study by their healthcare professional upon referral to a CR programme.

Patients providing verbal consent will then be contacted by a member of the research team. These patients will also be invited to take part in the qualitative interviews investigating long-term adherence to CR (after six months). In the event that too few of the patients are available for the interview after six months, further patients will be retrospectively identified through the patient records kept by the CR team.

Participant consent and withdrawal

Written informed consent will be sought from participants at all stages of the study including the initial survey, subsequent interviews and/or co-design event. It will be clear at all times throughout the research that participation is voluntary and withdrawal at any stage without challenge will be supported. Information relating to participant consent will make explicit than any data collected prior to the participants' withdrawal may be retained for analysis.

Survey

Surveys will be completed online or sent via post to all identified eligible patients. If a patient decides to complete the survey online, an accessible email link will be sent via a web link using a licensed copy of Qualtrics survey software. Participants will be asked to read the study information and sign/digitally tick consent before proceeding to the survey questions.

Interviews and co-design event

Eligible participants who are interested in our study will be provided with written information sheets and offered the opportunity to ask questions by phone, email or where possible, face-to-face with the local principal investigator and/or a member of the core research team at Sheffield Hallam University. Participants will be given a minimum of 24 hours to consider the study information, after which time they will be contacted to arrange attendance.

Ethical considerations

Risks to participants are estimated to be low; although it is possible there may be some emotional effect of discussing issues and experiences related to cardiovascular disease, treatment, and its potential impact on quality of life. Participants will be made aware of the nature of the topics to be discussed during the informed consent process so that they know what to expect. Participants will be made aware that they can withdraw from the study at any time, or avoid any topics that cause discomfort. The co-design workshop will be facilitated in a way that fosters sharing, non-judgment, and equality amongst group members. It is important to manage expectations that group discussions during workshops are for research purposes, and not directly intended as patient support groups. Links and contact details will be provided for patients who express a need for further support, both verbally and via participant information sheets.

Eligibility criteria: Inclusion criteria patients:

* Patients who fall within the National Audit of CR (NACR) priority groups. These include Myocardial Infarction (MI), MI + Percutaneous Coronary Intervention (PCI), PCI, Coronary Artery Bypass Graft (CAGB), and Heart Failure.
* Aged over 18 years (i.e., all adults).
* No evidence of cognitive impairment which will limit the ability to follow basic instructions.

Inclusion criteria professionals:

* Those who have a key responsibility for delivering or managing CR at one of the six local sites, including - healthcare professionals and/or CR providers.

Exclusion criteria patients:

* Patients who fall outside of the NACR priority groups.
* Aged under 18 years (i.e., all adults).
* Evidence of cognitive impairment which will limit the ability to follow basic instructions (Participants unable to give informed consent).

Exclusion criteria professionals:

* Trainee or administrative staff members.
* Staff members with less than four months of experience working in CR.

Primary outcomes:
measure: Reasons people attend early cardiac rehabilitation (quantitative method).
timeFrame: Start of cardiac rehabilitation
measure: Attendance to early cardiac rehabilitation
timeFrame: End of cardiac rehabilitation ~ 8 weeks.
measure: Reasons people adhere to early cardiac rehabilitation (quantitative method).
timeFrame: End of cardiac rehabilitation ~ 8 weeks
measure: Reasons people adhere to cardiac rehabilitation (qualitative method).
timeFrame: End of cardiac rehabilitation ~ 8 weeks
measure: Reasons people adhere to core components of cardiac rehabilitation (quantitative method).
timeFrame: 6 months after completion of cardiac rehabilitation
measure: Reasons people adhere to components of cardiac rehabilitation in the long term (qualitative method).
timeFrame: 6 months after completion of cardiac rehabilitation
measure: Reasons people drop-out of cardiac rehabilitation (quantitative method).
timeFrame: End of cardiac rehabilitation ~ 8 weeks
measure: Reasons people drop-out of cardiac rehabilitation (quantitative method).
timeFrame: 6 months after completion of cardiac rehabilitation
measure: Drop-out of early cardiac rehabilitation (quantitative method)
timeFrame: End of cardiac rehabilitation ~ 8 weeks.
measure: Reasons people drop-out of early cardiac rehabilitation (qualitative method)
timeFrame: End of cardiac rehabilitation ~ 8 weeks.
Secondary outcomes:
measure: Patient perceptions on which components of cardiac rehabilitation improve health related quality of life (quantitative method).
timeFrame: Start of cardiac rehabilitation
measure: Patient perceptions on which components of cardiac rehabilitation improve health related quality of life (quantitative method).
timeFrame: End of cardiac rehabilitation ~ 8 weeks
measure: Patient perceptions on which components of cardiac rehabilitation improve health related quality of life (quantitative method).
timeFrame: 6 months after completion of cardiac rehabilitation
measure: Patient perceptions on which components of cardiac rehabilitation improve health related quality of life (qualitative method).
timeFrame: End of cardiac rehabilitation ~ 8 weeks
measure: Patient perceptions on which components of cardiac rehabilitation improve health related quality of life (qualitative method).
timeFrame: 6 months after completion of cardiac rehabilitation
measure: Professional perspectives of supporting adherence to core components of cardiac rehabilitation (qualitative method).
timeFrame: Within 5 months from study start date.
Other outcomes:
measure: Intervention development
timeFrame: 10 months after study start date
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust
state: Blyth
city: Ystrad Mynach
country: United Kingdom
facility: Aneurin Bevan University Health Board
state: Gwent
city: London
country: United Kingdom
facility: Royal Brompton Hospital
state: Harefield Middlesex
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals
state: South Yorkshire
city: Belfast
country: United Kingdom
facility: Belfast Health and Social Care Trust
city: Kilmarnock
country: United Kingdom
facility: NHS Ayrshire and Arran
Study officials:
References: