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Patient-reported Outcomes After Percutaneous Coronary Intervention (CONCARD)

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ClinicalTrials.gov Identifier: NCT03810612
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Collaborators:
Helse Stavanger HF
Oslo University Hospital
Zealand University Hospital
Odense University Hospital
Rigshospitalet, Denmark
Herlev and Gentofte Hospital
Western Norway University of Applied Sciences
Information provided by (Responsible Party):
Haukeland University Hospital

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.

Condition or disease
Coronary Artery Disease

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Continuity of Care, Adherence to Treatment and Self-reported Health After Percutaneous Coronary Intervention (CONCARD): a Patient-centered Care Study
Actual Study Start Date : June 12, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2030



Primary Outcome Measures :
  1. Continuity of care [ Time Frame: 2 months ]
    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. Evaluation of the quality of healthcare delivery [ Time Frame: 2 months ]
    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.

  3. Change in eHealth literacy [ Time Frame: 2 months, 12 months ]
    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).

  4. Change in health literacy [ Time Frame: 2 months, 12 months ]
    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.

  5. Patient knowledge, skill, and confidence for self-management. [ Time Frame: 6 months ]
    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. Change in beliefs and perceptions about medicines and treatment [ Time Frame: 2 months, 6 months, 12 months ]
    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).

  7. Change in self-reported adherence to medicines [ Time Frame: 2 months, 6 months, 12 months ]
    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).

  8. Change in medication use [ Time Frame: 2 months, 6 months, 12 months ]
    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.

  9. Health care utilization [ Time Frame: Up to 24 months ]
    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.

  10. Health care (associated) costs [ Time Frame: Up to 24 months ]
    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.


Secondary Outcome Measures :
  1. Time to readmission to hospital [ Time Frame: 30-days, 3 months, 6 months, 12 months, up to 10 years ]
    Cardiac and all cause readmissions

  2. Time to death [ Time Frame: 30-days, 3 months, 6 months, 12 months, up to 10 years ]
    Cardiac and all cause mortality

  3. Change in anxiety and depression [ Time Frame: 2 months, 6 months, 12 months ]
    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).

  4. Change in self-reported health [ Time Frame: 2 months, 6 months, 12 months ]
    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.

  5. Change in chest pain [ Time Frame: 2 months, 6 months, 12 months ]
    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).

  6. Change in fatigue [ Time Frame: 2 months, 6 months,12 months ]
    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

  7. Frailty status [ Time Frame: 12 months ]
    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.

  8. Patient preferences in discrete choice experiments [ Time Frame: 3 months ]
    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.

  9. Health related quality of life [ Time Frame: 12 months ]
    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.

  10. Change in physical and mental dimensions of health. [ Time Frame: 2 months, 6 months, 12 months ]
    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}".

  11. Change in health status following myocardial infarction [ Time Frame: 2 months, 6 months, 12 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have undergone percutaneous coronary intervention will be included prospectively at each percutaneous coronary intervention centre.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810612


Contacts
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Contact: Tone M Norekvål, PhD +4799044635 tone.merete.norekval@helse-bergen.no
Contact: Nina B Fålun, MSc +4790858527 nina.falun@helse-bergen.no

Locations
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Denmark
Herlev and Gentofte Hospital Completed
Copenhagen, Denmark, 1092
Rigshospitalet, Copenhagen Recruiting
Copenhagen, Denmark, 2100
Contact: Pernille P Johansen, PhD    +4525361356    pernille.palm.johansen@regionh.dk   
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Britt Borregaard, MSc    +4526661136    Britt.Borregaard@rsyd.dk   
Zealand University Hospital Recruiting
Roskilde, Denmark, 4000
Contact: Tina B Hansen, PhD    +4528309754    tbh@regionsjaelland.dk   
Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Tone M Norekvål, PhD    +4799044635    tone.merete.norekval@helse-bergen.no   
Oslo University Hospital, Rikshospitalet Recruiting
Oslo, Norway, 0424
Contact: Bjørn Bendz, PhD    +4795802582    bbendz@ous-hf.no   
Stavanger University Hospital Recruiting
Stavanger, Norway, 4068
Contact: Alf Inge Larsen, PhD    +4795889896    alf.inge.larsen@sus.no   
Sponsors and Collaborators
Haukeland University Hospital
Helse Stavanger HF
Oslo University Hospital
Zealand University Hospital
Odense University Hospital
Rigshospitalet, Denmark
Herlev and Gentofte Hospital
Western Norway University of Applied Sciences
Investigators
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Principal Investigator: Tone M Norekvål, PhD Haukeland University Hospital

Additional Information:
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT03810612     History of Changes
Other Study ID Numbers: 2015/57
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haukeland University Hospital:
Adherence to treatment
Continuity of care
Health literacy
Patient involvement
Patient preferences
Percutaneous coronary intervention
Rehabilitation
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases