Optimising Secondary Prevention and Quality of Life in Early Cardiac Rehabilitation

NCT04781699 | Unknown

• 1 other identifier: ER22491844
• Study Type: observational
• Target: 498
• Locations: 1 country
• Sites: 6

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.

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

Outcome Measures

Primary Outcomes (10)

• Reasons people attend early cardiac rehabilitation (quantitative method).

  Using a pre-developed questionnaire.

  Start of cardiac rehabilitation

• Attendance to early cardiac rehabilitation

  Measured by number of patients referred to cardiac rehabilitation and proportion who take up cardiac rehabilitation.

  End of cardiac rehabilitation ~ 8 weeks.

• Reasons people adhere to early cardiac rehabilitation (quantitative method).

  Using a pre-developed questionnaire.

  End of cardiac rehabilitation ~ 8 weeks

• Reasons people adhere to cardiac rehabilitation (qualitative method).

  Using a semi-structured qualitative interview.

  End of cardiac rehabilitation ~ 8 weeks

• Reasons people adhere to core components of cardiac rehabilitation (quantitative method).

  Using a pre-developed questionnaire.

  6 months after completion of cardiac rehabilitation

• Reasons people adhere to components of cardiac rehabilitation in the long term (qualitative method).

  Using a semi-structured qualitative interview.

  6 months after completion of cardiac rehabilitation

• Reasons people drop-out of cardiac rehabilitation (quantitative method).

  Using a pre-developed questionnaire.

  End of cardiac rehabilitation ~ 8 weeks

• Reasons people drop-out of cardiac rehabilitation (quantitative method).

  Using a pre-developed questionnaire.

  6 months after completion of cardiac rehabilitation

• Drop-out of early cardiac rehabilitation (quantitative method)

  Drop-out will be defined as attending less than 50% of sessions.

  End of cardiac rehabilitation ~ 8 weeks.

• Reasons people drop-out of early cardiac rehabilitation (qualitative method)

  Using a semi-structured qualitative interview.

  End of cardiac rehabilitation ~ 8 weeks.

Secondary Outcomes (6)

• Patient perceptions on which components of cardiac rehabilitation improve health related quality of life (quantitative method).

  Start of cardiac rehabilitation

• Patient perceptions on which components of cardiac rehabilitation improve health related quality of life (quantitative method).

  End of cardiac rehabilitation ~ 8 weeks

• Patient perceptions on which components of cardiac rehabilitation improve health related quality of life (quantitative method).

  6 months after completion of cardiac rehabilitation

• Patient perceptions on which components of cardiac rehabilitation improve health related quality of life (qualitative method).

  End of cardiac rehabilitation ~ 8 weeks

• Patient perceptions on which components of cardiac rehabilitation improve health related quality of life (qualitative method).

  6 months after completion of cardiac rehabilitation

Other Outcomes (1)

• Intervention development

  10 months after study start date

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sheffield Hallam University: lead
• AstraZeneca: collaborator
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator
• Royal Brompton & Harefield NHS Foundation Trust: collaborator
• Northumbria Healthcare NHS Foundation Trust: collaborator
• NHS Ayrshire and Arran: collaborator
• Belfast Health and Social Care Trust: collaborator
• Aneurin Bevan University Health Board: collaborator

Study Sites (6)

Northumbria Healthcare NHS Foundation Trust

Newcastle upon Tyne, Blyth, NE24 1DX, United Kingdom

RECRUITING

Aneurin Bevan University Health Board

Ystrad Mynach, Gwent, CF82 7GP, United Kingdom

RECRUITING

Royal Brompton Hospital

London, Harefield Middlesex, UB9 6JH, United Kingdom

RECRUITING

Sheffield Teaching Hospitals

Sheffield, South Yorkshire, S5 7AU, United Kingdom

RECRUITING

Belfast Health and Social Care Trust

Belfast, BT9 7AB, United Kingdom

NOT YET RECRUITING

NHS Ayrshire and Arran

Kilmarnock, KA2 0BE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Artery Disease; Myocardial Infarction; Acute Coronary Syndrome; Coronary Disease; Heart Failure; Medication Adherence; Smoking Cessation; Motor Activity

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Simon Nichols, PhD

CONTACT

01142254327; s.j.nichols@shu.ac.uk

Gabbi Frith, MSc

CONTACT

01142252524; gabbi.frith@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 4, 2021
• Study Start: March 19, 2021
• Primary Completion: April 1, 2022
• Study Completion: September 1, 2022
• Last Updated: November 8, 2021

Record last verified: 2021-11

Locations

GB (6)