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Patient-reported Outcomes After Percutaneous Coronary Intervention (CONCARD)

H

Haukeland University Hospital

Status

Active, not recruiting

Conditions

Coronary Artery Disease

Study type

Observational

Funder types

Other

Identifiers

NCT03810612
2015/57

Details and patient eligibility

About

The main objective is to investigate i) continuity of care, ii) health literacy and self-management, iii) adherence to treatment, and iv) patient preferences, healthcare utilization and costs, and to determine associations with future short- and long-term health outcomes in patients after percutaneous coronary intervention.

Full description

CONCARD will use multiple designs. (1) An inductive exploratory design including in-depth interviews on patients' experiences of healthcare delivery will provide a context for the quantitative data to develop the content of the cohort study and trial intervention. (2) A prospective cohort design with a 1-year follow-up period will include data on patient-reported outcomes, and a 10-year follow-up for adverse events. In translation and adaptation of patient-reported outcome measures, a methodological design will be applied. (3) A discrete choice experiment will investigate patient preferences for aftercare and cardiac rehabilitation.

Enrollment

3,417 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients undergoing percutaneous coronary intervention
  • ≥ 18 years of age
  • Living at home at the time of inclusion.

Exclusion criteria

  • Patients who do not speak Norwegian/Danish
  • Patients who are unable to fill in the questionnaires due to reduced capacities
  • Institutionalized patients
  • Patients with expected lifetime less than one year
  • Percutaneous coronary intervention without stent implantation
  • Patients undergoing percutaneous coronary intervention related to Transcatheter Aortic Valve Implantation or Mitraclip examination
  • Previous enrollment in CONCARD (readmissions).

Trial contacts and locations

7

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Central trial contact

Nina B Fålun, MSc; Tone M Norekvål, PhD

Data sourced from clinicaltrials.gov

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