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Coronary Artery DiseaseCONCARDNCT03810612

Patient-reported Outcomes After Percutaneous Coronary Intervention

An observational study of Coronary Artery Disease, run by Haukeland University Hospital at 7 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
How many people
3,417 participants
Where
7 sitesin 2 countries
Study dates
12 Jun 2017to May 2030
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

Denmark4 sites

  • Herlev and Gentofte Hospital

    Copenhagen, 1092

  • Rigshospitalet, Copenhagen

    Copenhagen, 2100

  • Odense University Hospital

    Odense, 5000

  • Zealand University Hospital

    Roskilde, 4000

Other trials in Denmark

Norway3 sites

  • Haukeland University Hospital

    Bergen, 5021

  • Oslo University Hospital, Rikshospitalet

    Oslo, 0424

  • Stavanger University Hospital

    Stavanger, 4068

Other trials in Norway

About this study

Official title: Continuity of Care, Adherence to Treatment and Self-reported Health After Percutaneous Coronary Intervention (CONCARD): a Patient-centered Care Study

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.

Read the detailed 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.

Keywords
Adherence to treatment, Continuity of care, Health literacy, Patient involvement, Patient preferences, Percutaneous coronary intervention, Rehabilitation
Medical subject headings
Coronary Artery Disease, Treatment Adherence and Compliance, Patient Participation, Patient Preference

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 2 months

  2. 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.

    Measured: 2 months

  3. 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).

    Measured: 2 months, 12 months

  4. 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.

    Measured: 2 months, 12 months

  5. 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.

    Measured: 6 months

  6. 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).

    Measured: 2 months, 6 months, 12 months

  7. 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).

    Measured: 2 months, 6 months, 12 months

  8. 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.

    Measured: 2 months, 6 months, 12 months

  9. 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.

    Measured: Up to 24 months

  10. 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.

    Measured: Up to 24 months

Secondary outcomes (11)

  1. Time to readmission to hospital

    Cardiac and all cause readmissions

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

  2. Time to death

    Cardiac and all cause mortality

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

  3. Change in anxiety and depression

    The Hospital Anxiety and Depression Scale (HADS). The HADS is a fourteen item scale where seven of the items relate to anxiety and seven relate to depression. The respondent rates each item on a 4-point scale ranging from 0 (absence) to 3 (extreme presence). The total score is 42 (21 per subscale).

    Measured: 2 months, 6 months, 12 months

  4. Change in self-reported health

    EQ-5D-5L is an 5 item (plus a VAS scale) self-report-questionnaire assessing self-reported health. Each question has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

    Measured: 2 months, 6 months, 12 months

  5. Change in chest pain

    The Seattle Angina Questionnaire (SAQ-7) comprises 7 dimensions of coronary artery disease. Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).

    Measured: 2 months, 6 months, 12 months

  6. Change in fatigue

    A visual analog scale ranging from 0 (fatigue is not a problem) to 10 (fatigue is a major problem) is used to measure change in fatigue

    Measured: 2 months, 6 months,12 months

  7. Frailty status

    The Study of Osteoporotic Fractures (SOF) index will be used to measure frailty status. The SOF index includes three items: 1) weight loss > 5% in the last year, 2) inability to rise from a chair five times without using arms, and 3) reduced energy level. The questions have dichotomous response alternatives (yes/no). Patients who meet none of these criteria will be considered robust, one of the criteria are pre-frail, and two or three of these criteria are considered frail.

    Measured: 12 months

  8. Patient preferences in discrete choice experiments

    A discrete choice experiment (DCE) is a quantitative technique for eliciting preferences to be used in the absence of revealed preference data. This involves asking individuals to state their preference over hypothetical alternative scenarios. Each alternative is described by several attributes which are used to determine if preferences are significantly influenced by these. No standardized measurement tool is used in DCE. The alternative scenarios (attributes) are developed for each individual study. Therefore, a DCE will be undertaken as a cross-sectional survey to investigate the preferences for aftercare. Participants are asked to choose between hypothetical aftercare programs described by five key characteristics that varies across each of the respondents' choices. The DCE will be carried out according to recommendations by the ISPOR group. A multinomial mixed logit model are used to model preferences and calculate marginal rates of substitution.

    Measured: 3 months

  9. Health related quality of life

    The HeartQoL questionnaire is a core ischemic heart disease specific health related quality of life (HRQL) questionnaire. The questionnaire comprises 14-items with 10-item physical and 4-item emotional subscales which are scored from 0 (poor HRQL) to 3 (better HRQL) with a global score if needed.

    Measured: 12 months

  10. Change in physical and mental dimensions of health.

    RAND-12 measures physical and mental dimensions of health. The 12 items in the questionnaire correspond to eight principal physical and mental health domains. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}".

    Measured: 2 months, 6 months, 12 months

  11. Change in health status following myocardial infarction

    The Myocardial Infarction Dimensional Assessment Scale (MIDAS) is a PRO measure developed and validated to specifically measure the health status of individuals who have suffered a myocardial infarction. It consist of 7 domains, and is a 35 item scale where respondents rate each item on a 5-point scale ranging from 1 (never) to 5 (always). The function of the MIDAS is to indicate the extent of ill health in each of the seven domains assessed, therefore each dimension is scored separately using a simple scoring methodology.

    Measured: 2 months, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2019
  2. Study start12 Jun 2017
  3. Primary completionMay 2030 (estimated)
  4. Study completionMay 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,417 participants (actual)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03810612
Sponsor's protocol ID
2015/57
Acronym
CONCARD
Status last verified
Jun 2026
First submitted
21 Dec 2018
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40188074

  • 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.

    PubMed 38183067

  • 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.

    PubMed 36974270

  • 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.

    PubMed 36190843

  • 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.

    PubMed 32720900

  • 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.

    PubMed 32054625

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Haukeland University Hospital at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Denmark, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Continuity of care (time frame: 2 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03810612, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

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