Patient-reported Outcomes After Percutaneous Coronary Intervention

NCT ID: NCT03810612

Last Updated: 2024-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

3417 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-12

Study Completion Date

2030-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helse Stavanger HF

OTHER_GOV

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

Zealand University Hospital

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Herlev and Gentofte Hospital

OTHER

Sponsor Role collaborator

Western Norway University of Applied Sciences

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tone M Norekvål, PhD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

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Herlev and Gentofte Hospital

Copenhagen, , Denmark

Site Status

Rigshospitalet, Copenhagen

Copenhagen, , Denmark

Site Status

Odense University Hospital

Odense, , Denmark

Site Status

Zealand University Hospital

Roskilde, , Denmark

Site Status

Haukeland University Hospital

Bergen, , Norway

Site Status

Oslo University Hospital, Rikshospitalet

Oslo, , Norway

Site Status

Stavanger University Hospital

Stavanger, , Norway

Site Status

Countries

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Denmark Norway

References

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Norekval TM, Iversen MM, Oterhals K, Allore H, Borregaard B, Pettersen TR, Thompson DR, Zwisler AD, Breivik K. Perfect health not so perfect after all - a methodological study on patient-reported outcome measures in 2574 patients following percutaneous coronary intervention. Health Qual Life Outcomes. 2025 Apr 5;23(1):35. doi: 10.1186/s12955-025-02360-4.

Reference Type DERIVED
PMID: 40188074 (View on PubMed)

Hjertvikrem N, Brors G, Instenes I, Helmark C, Pettersen TR, Rotevatn S, Zwisler ADO, Norekval TM; CONCARDPCI Investigators. Use of health services and perceived need for information and follow-up after percutaneous coronary intervention. BMC Res Notes. 2024 Jan 5;17(1):20. doi: 10.1186/s13104-023-06662-y.

Reference Type DERIVED
PMID: 38183067 (View on PubMed)

Brors G, Dalen H, Allore H, Deaton C, Fridlund B, Norman CD, Palm P, Wentzel-Larsen T, Norekval TM. The association of electronic health literacy with behavioural and psychological coronary artery disease risk factors in patients after percutaneous coronary intervention: a 12-month follow-up study. Eur Heart J Digit Health. 2023 Feb 7;4(2):125-135. doi: 10.1093/ehjdh/ztad010. eCollection 2023 Mar.

Reference Type DERIVED
PMID: 36974270 (View on PubMed)

Ramstad KJ, Brors G, Pettersen TR, Deaton C, Palm P, Rotevatn S, Wentzel-Larsen T, Norekval TM. eHealth technology use and eHealth literacy after percutaneous coronary intervention. Eur J Cardiovasc Nurs. 2023 Jul 19;22(5):472-481. doi: 10.1093/eurjcn/zvac087.

Reference Type DERIVED
PMID: 36190843 (View on PubMed)

Brors G, Wentzel-Larsen T, Dalen H, Hansen TB, Norman CD, Wahl A, Norekval TM; CONCARD Investigators. Psychometric Properties of the Norwegian Version of the Electronic Health Literacy Scale (eHEALS) Among Patients After Percutaneous Coronary Intervention: Cross-Sectional Validation Study. J Med Internet Res. 2020 Jul 28;22(7):e17312. doi: 10.2196/17312.

Reference Type DERIVED
PMID: 32720900 (View on PubMed)

Norekval TM, Allore HG, Bendz B, Bjorvatn C, Borregaard B, Brors G, Deaton C, Falun N, Hadjistavropoulos H, Hansen TB, Igland S, Larsen AI, Palm P, Pettersen TR, Rasmussen TB, Schjott J, Sogaard R, Valaker I, Zwisler AD, Rotevatn S; CONCARD Investigators. Rethinking rehabilitation after percutaneous coronary intervention: a protocol of a multicentre cohort study on continuity of care, health literacy, adherence and costs at all care levels (the CONCARDPCI). BMJ Open. 2020 Feb 12;10(2):e031995. doi: 10.1136/bmjopen-2019-031995.

Reference Type DERIVED
PMID: 32054625 (View on PubMed)

Related Links

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Other Identifiers

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2015/57

Identifier Type: -

Identifier Source: org_study_id

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