NCT03810612

Brief Summary

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,417

participants targeted

Target at P75+ for all trials

Timeline
46mo left

Started Jun 2017

Longer than P75 for all trials

Geographic Reach
2 countries

7 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Jun 2017May 2030

Study Start

First participant enrolled

June 12, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
11.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

12.9 years

First QC Date

December 21, 2018

Last Update Submit

June 18, 2026

Conditions

Coronary Artery Disease

Keywords

Adherence to treatmentContinuity of careHealth literacyPatient involvementPatient preferencesPercutaneous coronary interventionRehabilitation

Outcome Measures

Primary Outcomes (10)

  • Continuity of care

    The Heart Continuity of Care Questionnaire (HCCQ) comprises 33 items covering eight topic areas regarding continuity of care. Respondents rate each item on a 6-point scale ranging from 1 (strongly disagree) to 5 (strongly agree) or 6 (not applicable).

    2 months

  • Evaluation of the quality of healthcare delivery

    The Nordic Patient Experiences Questionnaire (NORPEQ) comprises 8 items and gives a brief measure of patient experiences in evaluation of the quality of healthcare delivery. Respondents rate each item on a 5-point scale ranging from 1 (not at all) to 5 (to a large extent). Six of the eight NORPEQ items sum to produce an overall scale from 0 to 100, where 100 is the best possible experience of care.

    2 months

  • Change in eHealth literacy

    The eHealth Literacy Scale (Eheals) is an 8-item measure of eHealth literacy developed to measure consumers' combined knowledge, comfort, and perceived skills at finding, evaluating, and applying electronic health information to health problems. Respondents indicate their agreement with statements on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly agree).

    2 months, 12 months

  • Change in health literacy

    The Health literacy questionnaire (HLQ) has nine scale scores that each measure an aspect of the multidimensional construct of health literacy. Each score provides insight into the strengths and limitations of the respondent, but the scores are most powerful when viewed together to show the 'health literacy profile' of the respondent.

    2 months, 12 months

  • Patient knowledge, skill, and confidence for self-management.

    The Patient Activation Measure (PAM-13) comprises 13 items assessing patient knowledge, skill and confidence for self-management. Respondents indicate their agreement with statements on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 4 (Strongly agree), or 5 (not applicable). Patients with a high activation score were associated with fewer mental health symptoms, greater recovery attitudes and medication adherence.

    6 months

  • Change in beliefs and perceptions about medicines and treatment

    The Beliefs about Medicines Questionnaire (BMQ) assesses beliefs and perceptions about medicines and treatment. The BMQ comprises two sections: the BMQ-Specific which assesses representations of medication prescribed for personal use and the BMQ-General which assesses beliefs about medicines in general. The two sections of the BMQ can be used in combination or separately. For this study, the BMQ-Specific will be used. Respondents rate 11 items on a 5-point scale ranging from 1 (strongly agree) to 5 (strongly disagree).

    2 months, 6 months, 12 months

  • Change in self-reported adherence to medicines

    The Medication Adherence Report Scale (MARS-5) measures self-reported adherence to medicines, it assesses both intentional and unintentional non-adherence. Respondents indicate their agreement with statements about their medicine use on a 5 point Likert scale ranging from 1 (always) to 5 (never).

    2 months, 6 months, 12 months

  • Change in medication use

    Data related to consumption of prescribed medication are identified through national prescription registries. The registries cover all prescriptions dispensed at pharmacies nationwide. The registries also include information about date of dispensation, quantity and strength dispensed. This will serve as complimentary information to patients' self-reported adherence.

    2 months, 6 months, 12 months

  • Health care utilization

    Healthcare utilization will be assessed during follow-up, including patients' use of primary care services (general practitioner visits) and secondary care services (inpatient admissions and outpatient visits). The data source will be nationwide registries. The measurement unit will be mean number of visits.

    Up to 24 months

  • Health care (associated) costs

    Health care (associated) costs will be valued using the tariffs of national agreements between the professional associations of medical specialists and the National Health Services. In secondary care, inpatient admissions and outpatient visits will be valued using the tariffs of the national case-mix system of the diagnosis-related groupings (DRG) and the ambulatory grouping system (DAGS). In addition, data will be collected on prescription of medication, which will be valued using the retail price. The data source will be nationwide registries. The measurement unit will be mean costs in Euros.

    Up to 24 months

Secondary Outcomes (11)

  • Time to readmission to hospital

    30-days, 3 months, 6 months, 12 months, up to 10 years

  • Time to death

    30-days, 3 months, 6 months, 12 months, up to 10 years

  • Change in anxiety and depression

    2 months, 6 months, 12 months

  • Change in self-reported health

    2 months, 6 months, 12 months

  • Change in chest pain

    2 months, 6 months, 12 months

  • +6 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have undergone percutaneous coronary intervention will be included prospectively at each percutaneous coronary intervention centre.

You may qualify if:

  • Patients undergoing percutaneous coronary intervention
  • ≥ 18 years of age

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Herlev and Gentofte Hospital

Copenhagen, 1092, Denmark

Location

Rigshospitalet, Copenhagen

Copenhagen, 2100, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Zealand University Hospital

Roskilde, 4000, Denmark

Location

Haukeland University Hospital

Bergen, 5021, Norway

Location

Oslo University Hospital, Rikshospitalet

Oslo, 0424, Norway

Location

Stavanger University Hospital

Stavanger, 4068, Norway

Location

Related Publications (6)

  • 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.

    PMID: 40188074DERIVED

  • 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.

    PMID: 38183067DERIVED

  • 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.

    PMID: 36974270DERIVED

  • 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.

    PMID: 36190843DERIVED

  • 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.

    PMID: 32720900DERIVED

  • 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.

    PMID: 32054625DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseTreatment Adherence and CompliancePatient ParticipationPatient Preference

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesHealth BehaviorBehaviorPatient Acceptance of Health CarePatient Satisfaction

Study Officials

  • Tone M Norekvål, PhD

    Haukeland University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2018

First Posted

January 18, 2019

Study Start

June 12, 2017

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

May 1, 2030

Last Updated

June 23, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

DK(4)NO(3)