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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06239558
Other study ID # 0960
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 29, 2024
Est. completion date November 2024

Study information

Verified date January 2024
Source University of Leicester
Contact Joanne S McAllister
Phone 0116 258 3370
Email jsm53@leicester.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this qualitative study is to learn about the barriers and enablers to cardiac rehabilitation, experience by South Asian service users based in the UK who have experienced an acute cardiac event and been referred for CR. This may allow NHS programmes to make adaptations to their services to enhance uptake, adherence and completion for this ethnic population. The main questions it aims to answer are: - What are the barriers and enablers to uptake, adherence or completion of CR experienced by service users with South Asian heritage? - What adaptations to the CR service could be implemented to overcome identified barriers, enhance enablers and result in increased uptake, adherence or completion to CR? Participants will be invited to participate in a semi-structured interview and/or a focus group to explore lived experiences that can answer the research questions.


Description:

This study aims to explore contemporary barriers and enablers to uptake, adherence or completion of cardiac rehabilitation experienced by service users with South Asian heritage, and develop culturally relevant programme adaptations to overcome the identified barriers. Cardiac rehabilitation (CR) a highly evidenced exercise-based intervention offered to eligible patients who have experienced a cardiac event however South Asian service users are less likely to uptake, adhere to or complete CR. This may be because cultural acceptability of CR components (assessment, exercise and education sessions) are not fully considered or tailored for this ethnic population. This study will explore what barriers and enablers are experienced by South Asian service users, with a focus on cultural and psychosocial factors, and develop culturally relevant programme adaptations to increase uptake, adherence and completion. The study will also explore healthcare professionals (HCPs) perceptions of barriers and enablers to CR experienced by service users with South Asian heritage. Participants will include adult (≥ 18 years) service users who have a South Asian heritage and have been referred to University Hospitals of Leicester CR after a cardiac event. Participants will also include healthcare professions and key stakeholders involved in CR and health inequalities. Participants will be invited to a community-based interview (1 hour) and/or a workshop (3 hours) to provide their experiences of barriers and enablers to CR and help develop culturally appropriate service adaptations to overcome these barriers and enhance enablers, resulting increased uptake, adherence or completion of CR. The study is funded by the Wellcome Trust as part of the Leicestershire Health Inequalities Improvement Programme as the University of Leicester.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date November 2024
Est. primary completion date September 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Service Users - Adult aged =18 years - Has capacity to give consent - Been referred to UHL NHS Trust cardiac rehabilitation service - Has experienced an acute cardiac event which is eligible for CR provided by UHL CR service - Identifies their ethnicity as South Asian i.e. ancestral origins in India, Pakistan, Bangladesh, Afghanistan, Bhutan, Maldives, Nepal and Sri Lanka (Indian sub-continent). - Workshop only: be able to communicate in spoken English CR Healthcare Professionals - Adult aged =18 years - Has capacity to give consent - HCP involved in delivering direct patient care, who works within UHL NHS Trust CR service Key Stakeholders - Adult aged =18 years - Has capacity to give consent - Individuals who have a direct involvement with South Asian communities, tackling health inequalities, NHS commissioning or service development, or CR policy/guideline development Exclusion Criteria: Service Users - Child aged <18 years - Unable to give consent - Have not been referred to UHL NHS Trust CR services - Been referred to CR due to heart failure and will conduct CR within a community-provided breathlessness pathway - Does not self-identify as South Asian - Workshop only: unable to speak or understand spoken English CR Healthcare Professionals - Child aged <18 years - Unable to give consent - Not a CR team member involved in delivering direct patient care, who works within UHL NHS Trust CR service Key Stakeholders - Child aged <18 years - Unable to give consent - Not an individual who have a direct influence on South Asian communities, tackling health inequalities, NHS commissioning or service development, or CR policy/guideline development - Unable to attend workshop in person

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Qualitative exploration
Semi-structured Interviews and focus group

Locations

Country Name City State
United Kingdom Glenfield General Hospital Leicester Leicestershire

Sponsors (4)

Lead Sponsor Collaborator
University of Leicester National Institute for Health Research, United Kingdom, University Hospitals, Leicester, Wellcome Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Identification of contemporary barriers and enablers to cardiac rehabilitation Barriers and enablers to cardiac rehabilitation experienced by South Asian service users 90 minute interviews
Primary Cardiac Rehabilitation Programme Adaptations Adaptations to the service which could be implemented to overcome identified barriers, enhance enablers and result in increased uptake, adherence or completion. 3 hour interactive focus group
Secondary Healthcare professionals perceptions of barriers and enablers Healthcare professionals perceptions of barriers and enablers experienced by South Asian service users which may influence uptake, adherence to and completion of cardiac rehabilitation. 90 minute interviews
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