Actively Recruiting

All Genders
Healthy Volunteers
NCT06567626

Decision Support Tool for Revascularisation Options in Coronary Artery Disease

Led by University of Leicester · Updated on 2025-04-03

126

Participants Needed

2

Research Sites

150 weeks

Total Duration

On this page

Sponsors

U

University of Leicester

Lead Sponsor

U

University Hospitals, Leicester

Collaborating Sponsor

AI-Summary

What this Trial Is About

Together with patients and healthcare professionals, we want to design a Decision Support Tool (DST) that will help people with coronary artery disease to understand and choose treatments that best reflect their preferences and values. Coronary artery disease (CAD) is a leading cause of death. Blood vessels supplying oxygen to the heart muscle become narrowed by a gradual build-up of fatty material. This can result in heart attacks, heart failure, and sudden death. One way to treat the blockage is by inserting an inner sleeve called a "stent" into the blood vessel and clearing the blockage by forcing it into the artery wall. Another method involves diverting the blood supply around the blockage using a vessel harvested from another body site; this is called "bypass surgery". The best treatment, either stents or surgery, is different for everyone. A Decision Support Tool (DST) will provide key information on the pros and cons of stents or surgery and how these match an individual's preferences and values. People are then empowered to make shared decisions about treatment with their doctors. Personalising treatment decisions in this way can reduce inequalities in care and improve shared decision making. Our proposed research will develop a DST in the form of a webpage with alternative print material for those at risk of digital poverty. The DST will be developed in multiple languages to improve accessibility. There are two parts to the study: the first part will use the experience of patients, who have already had stent or surgery, and healthcare professionals to design and refine a DST prototype; this will be done through workshops, focus groups, and cognitive interviews. The second part will test whether it is possible to use the DST by people with CAD waiting for a procedure; this will be done through questionnaires and interviews. The result of this study can then subsequently inform an assessment of the refined DST on a national level, with the hopes of enabling more effective shared decision making.

CONDITIONS

Official Title

Decision Support Tool for Revascularisation Options in Coronary Artery Disease

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older with experience of coronary revascularisation
  • Willing and able to consent to participate
  • Able to understand written and spoken English for workshops or focus groups (not required for interviews or questionnaires)
  • Healthcare professionals with patient-facing roles involving coronary revascularisation decision making
  • Adults awaiting coronary revascularisation who have had coronary angiography
  • Able to understand written and spoken English, Polish, Romanian, Urdu, Panjabi, or Gujarati
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Individuals who participate in focus groups cannot take part later in interviews or questionnaires
  • Clinical consensus strongly recommends only one revascularisation option
  • Unable to speak any of the specified languages (English, Polish, Romanian, Urdu, Panjabi, Gujarati)

AI-Screening

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Trial Site Locations

Total: 2 locations

1

University of Leicester

Leicester, United Kingdom, LE1 7RH

Not Yet Recruiting

2

University Hospitals of Leicester

Leicester, United Kingdom, LE39QP

Actively Recruiting

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Research Team

D

Dr Ann Cheng

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Decision Support Tool for Revascularisation Options in Coronary Artery Disease | DecenTrialz