Status:
RECRUITING
Decision Support Tool for Revascularisation Options in Coronary Artery Disease
Lead Sponsor:
University of Leicester
Collaborating Sponsors:
University Hospitals, Leicester
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
Brief Summary
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 re...
Eligibility Criteria
Inclusion
- WP1. DST CO-DESIGN PATIENT PARTICIPANTS
- Inclusion Criteria
- Participants may enter the study if ALL of the following applies:
- Any adult (≥ 18 years) with lived experience of coronary revascularisation
- Willing and able to consent to study participation.
- Able to understand written and spoken English for decisional needs workshop or focus groups (NB this criterion is not required for cognitive interviews or acceptability questionnaire)
- Exclusion Criteria
- Participants may not enter the study if they are unable to provide informed consent. Individuals who participate in focus groups are ineligible for subsequent participation in cognitive interviews and acceptability questionnaires.
- WP1. DST CO-DESIGN HCP PARTICIPANTS
- Inclusion Criteria
- Participants may enter the study if ALL of the following applies:
- Healthcare professional with a patient-facing clinical role which involves decision making regarding coronary revascularisation
- Willing and able to consent to study participation.
- Able to understand written and spoken English
- Exclusion Criteria
- Participants may not enter the study if they are unable to provide informed consent.
- WP2. DST FEASIBILITY PATIENT PARTICIPANTS
- Inclusion Criteria
- Participants may enter the study if ALL of the following applies:
- Adult (≥ 18 years) awaiting coronary revascularisation
- Has received coronary angiography for definitive diagnosis.
- Willing and able to consent to study participation.
- Able to understand written and spoken English, Polish, Romanian, Urdu, Panjabi, or Gujarati
- Exclusion Criteria
- Participants may not enter the trial if ANY of the following apply:
- Where clinical consensus strongly recommends one option of revascularisation over another
- Unable to provide informed consent
- Unable to speak one of the aforementioned 6 languages
- WP2. DST FEASIBILITY HCP PARTICIPANTS
- Inclusion Criteria
- Participants may enter the study if ALL of the following applies:
- Healthcare professional with a patient-facing clinical role which involves decision making regarding coronary revascularisation
- Willing and able to consent to study participation.
- Able to understand written and spoken English
- Exclusion Criteria
- Participants may not enter the study if they are unable to provide informed consent.
Exclusion
Key Trial Info
Start Date :
October 11 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT06567626
Start Date
October 11 2024
End Date
September 1 2027
Last Update
April 3 2025
Active Locations (2)
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1
University of Leicester
Leicester, United Kingdom, LE1 7RH
2
University Hospitals of Leicester
Leicester, United Kingdom, LE39QP