Cardiac RehabilitationNCT06239558
Cardiac Rehabilitation Participation and South Asian Service Users
An observational study of Cardiac Rehabilitation and South Asian Service Users, run by University of Leicester at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Rehabilitation, South Asian Service Users
- What is being tested?
- Qualitative exploration
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Feb 2024to Nov 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: * adults referred to cardiac rehabilitation with South Asian heritage * cardiac rehabilitation (CR) healthcare professionals working at University of Leicester Hospitals CR service * key stakeholders
Who may be able to join
- 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).
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- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Glenfield General Hospital
Leicester, Leicestershire, LE3 9QP
Joanne S McAllister, 0116 258 3370, jsm53@leicester.ac.uk
Sally J Singh, PhD
About this study
Official title: Barriers and Enablers to Cardiac Rehabilitation Uptake, Adherence and Completion Experienced by Service Users With South Asian Heritage
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.
Read the detailed 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.
- Conditions
- Cardiac Rehabilitation, South Asian Service Users
- Being tested
- Qualitative exploration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative explorationOther
Semi-structured Interviews and focus group
| Study group | Role | What they receive |
|---|---|---|
| South Asian Service Users | Service users who identify themselves as South Asian will be invited to participant in a semi-structured interview and/or a focus group. The interview will be used to identify lived experiences of the barriers and enablers to cardiac rehabilitation, relating to uptake, adherence or completion. The focus group will be used to collaboratively generate adaptations to CR services which could be implemented to overcome the barriers, and enhance the enablers, identified during the interviews. Receives: Other: Qualitative exploration | |
| Cardiac Rehabilitation Healthcare Professionals | The rehabilitation healthcare professionals will be invited to participant in a semi-structured interview and/or a focus group. The interviews will be used to explore their the perceptions of barriers and enablers and knowledge around the cultural requirements of South Asian service users. Receives: Other: Qualitative exploration | |
| Key stakeholders | Key stakeholders relating to cardiac rehabilitation, University Hospitals of Leicester (UHL) NHS Trust, and/or South Asian communities will be invited to participate in the focus group, helping to generate adaptations to CR services. Receives: Other: Qualitative exploration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of contemporary barriers and enablers to cardiac rehabilitation
Barriers and enablers to cardiac rehabilitation experienced by South Asian service users
Measured: 90 minute interviews
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.
Measured: 3 hour interactive focus group
Secondary outcomes (1)
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.
Measured: 90 minute interviews
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start29 Feb 2024
- Primary completionSep 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, University Hospitals, Leicester, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Sally J Singh, PhD, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239558
- Sponsor's protocol ID
- 0960
- Status last verified
- Jan 2024
- First submitted
- 24 Jan 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers and Enablers to Cardiac Rehabilitation Uptake, Adherence and Completion Experienced by Service Users With South Asian Heritage
- ClinicalTrials.gov ID
- NCT06239558
- Acronym / sponsor ID
- 0960
- Conditions
- Cardiac Rehabilitation, South Asian Service Users
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- Wellcome Trust, University Hospitals, Leicester, National Institute for Health Research, United Kingdom
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 2 Feb 2024 (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.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| South Asian Service Users | – | Other: Qualitative explorationService users who identify themselves as South Asian will be invited to participant in a semi-structured interview and/or a focus group. The interview will be used to identify lived experiences of the barriers and enablers to cardiac rehabilitation, relating to uptake, adherence or completion. The focus group will be used to collaboratively generate adaptations to CR services which could be implemented to overcome the barriers, and enhance the enablers, identified during the interviews. |
| Cardiac Rehabilitation Healthcare Professionals | – | Other: Qualitative explorationThe rehabilitation healthcare professionals will be invited to participant in a semi-structured interview and/or a focus group. The interviews will be used to explore their the perceptions of barriers and enablers and knowledge around the cultural requirements of South Asian service users. |
| Key stakeholders | – | Other: Qualitative explorationKey stakeholders relating to cardiac rehabilitation, University Hospitals of Leicester (UHL) NHS Trust, and/or South Asian communities will be invited to participate in the focus group, helping to generate adaptations to CR services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * adults referred to cardiac rehabilitation with South Asian heritage * cardiac rehabilitation (CR) healthcare professionals working at University of Leicester Hospitals CR service * key stakeholders
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| Qualitative explorationSemi-structured Interviews and focus group | Other | Cardiac Rehabilitation Healthcare Professionals, Key stakeholders, South Asian Service Users |
Primary outcome
Identification of contemporary barriers and enablers to cardiac rehabilitation
Time frame: 90 minute interviews
Barriers and enablers to cardiac rehabilitation experienced by South Asian service users
Cardiac Rehabilitation Programme Adaptations
Time frame: 3 hour interactive focus group
Adaptations to the service which could be implemented to overcome identified barriers, enhance enablers and result in increased uptake, adherence or completion.
1 secondary outcome
Healthcare professionals perceptions of barriers and enablers
Time frame: 90 minute interviews
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Sally J Singh, PhD principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Rehabilitation and South Asian Service Users, run by University of Leicester at 1 site in United Kingdom.
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 15 inclusion and 16 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 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Joanne S McAllister (0116 258 3370, jsm53@leicester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of contemporary barriers and enablers to cardiac rehabilitation (time frame: 90 minute interviews). The study lists 2 primary outcomes in all. 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 13 Mar 2024.