Ischemic Heart DiseasesRACAT-COVIDNCT06530472
The Relationship Between Belief, Expectation, and Adherence to Therapy During COVID-19 Pandemic
An observational study of Ischemic Heart Diseases, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
The goal of this [type of study: observational study or clinical trial ] is to learn about, test, compare etc.] in [ describe participant population/health conditions ]. The main question [ it aims to answer are: [question [question Participants will [describe the main tasks participants will be asked to do… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Diseases
- What is being tested?
- Monitoring
- How many people
- 196 participants
- Where
- 1 siteItaly
- Study dates
- 18 May 2021to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: All patients diagnosed with ischaemic heart disease established by angiography
Who may be able to join
- all patients diagnosed with ischaemic heart disease established by angiography;
- reaching the age of majority;
- score >= 26 on the Montreal Cognitive Assessment (MoCA) test (Nasreddine et al., 2005).
Who cannot join
- presence of comorbidity with other pathologies in an active or advanced phase; -patients with a prognosis to be defined;
- pregnancy;
- participants with neurological pathologies that significantly impair their cognitive functions (e.g. advanced Parkinson's disease; Alzheimer's dementia...cardiac arrest with hypoxic damage);
- participants with cognitive impairments that compromise comprehension and sharing of the contents of the questions, detected through the administration of the Montreal Cognitive Assessment (MoCA) test (Nasreddine et al., 2005).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Belief, Expectation, and Adherence to Therapy During COVID-19 Pandemic: a Multigroup Cohort Study in Patients With Ischemic Heart Disease
The goal of this [type of study: observational study or clinical trial ] is to learn about, test, compare etc.] in [ describe participant population/health conditions ]. The main question [ it aims to answer are:
- [question
- [question Participants will [describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items ].
If there is a comparison group: Researchers will compare insert groups ] to see if insert effects
- Conditions
- Ischemic Heart Diseases
- Being tested
- Monitoring
- Keywords
- Ischemic Heart Disease, Adherence, Belief, Acceptance, COVID-19
- Medical subject headings
- Myocardial Ischemia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonitoringOther
At baseline, 3, 6 and 12 months, people will undergo to both a psychological and cardiological assessment.
| Study group | Role | What they receive |
|---|---|---|
| Fondazione Don Carlo Gnocchi | All patients diagnosed with ischaemic heart disease established by angiography; attained age of majority; Score >= 26 on the Montreal Cognitive Assessment (MoCA) test. At baseline, 3, 6 and 12 months, people will undergo to both a psychological and cardiological assessment. Receives: Other: Monitoring | |
| Ospedale Valduce | All patients diagnosed with ischaemic heart disease established by angiography; attained age of majority; Score >= 26 on the Montreal Cognitive Assessment (MoCA) test. At baseline, 3, 6 and 12 months, people will undergo to both a psychological and cardiological assessment. Receives: Other: Monitoring | |
| Ospedale Cà Granda Niguarda | All patients diagnosed with ischaemic heart disease established by angiography; attained age of majority; Score >= 26 on the Montreal Cognitive Assessment (MoCA) test. At baseline, 3, 6 and 12 months, people will undergo to both a psychological and cardiological assessment. Receives: Other: Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Measured by the percentage of days covered (Percentage of Days Covered, PDC) by antiplatelet therapy, beta-blockers, statins, ACE-I/Sartan, hypoglycaemic drugs, psychotropic drugs (anxiolytics; antidepressants).
The PDC is defined as the proportion of days for which a patient has a supply of medication available. When multiple prescriptions are for the same day, reference is made to the maximum duration, and for overlapping prescriptions, sequential use of the two prescriptions is assumed by summing the days of supply for each. Any interruptions in therapy are also taken into account. Non-adherence is defined as a PDC of less than 80%, while non-persistence is defined as a gap in prescriptions of (Direct Oral Anticoagulants or Direct Oral Anticoagulants) DOACs ≥14 days (Yu et al., 2020).
Measured: At baseline, 3, 6 and 12 months from the recruitment
NACE
Net adverse clinical event or NACE, defined as a composite of all-cause mortality, myocardial infarction, stroke or major haemorrhage. In this case, bleeding is definitive according to the BARC (Bleeding Academic Research Consortium) scale (Mehran et al., 2011).
Measured: At baseline, 3, 6 and 12 months from the recruitment
MARS-i
Measure with theMARS-5-i questionnaire consists of five questions on forgetting, changing dosage, stopping, skipping, and taking less medication . The score ranges from 5 to 25, where a higher MARS-5-i score indicates higher self-reported adherence. One item assesses unintentional non-adherence and four items assess intentional non-adherence
Measured: At baseline, 3, 6 and 12 months from the recruitment
Secondary outcomes (11)
Extra visits
Number of extra (unplanned) visits, frequency of planned follow-up visits
Measured: At baseline, 3, 6 and 12 months from the recruitment
Adherence to pharmacotherapy
Measured as difference between number of pills taken and number of pills prescribed.
At each time of data collection, monitoring will be carried out for all four recommended therapies in patients with reduced ejection fraction (entero, jardiance, beta blockade, anti-aldosterone).
It is also intended to detect how many patients, at one year, have optimal control of risk factors, in terms of lipid profile at target, glycaemic control, smoking cessation, maintenance of regular physical activity, BMI improvement (considering LDL value, fasting blood glucose, HbA1 for diabetics).
Measured: At baseline, 3, 6 and 12 months from the recruitment
CAS
Measured by the Coronavirus Anxiety Scale (CAS) (Lee, 2020; Silva et al., 2020), which assesses dysfunctional anxiety associated with the Covid-19 crisis. Each item on the CAS is rated on a 5-point scale, from 0 (not at all) to 4 (almost every day), based on experiences over the past two weeks. This scale format is consistent with the DSM-5 measure of cross-sectional symptoms. A total CAS score ≥ 9 indicates probable coronavirus-related dysfunctional anxiety. High scores on a particular item or a high total scale score (≥ 9) may indicate problematic symptoms for the individual that may warrant further assessment and/or treatment. Clinical judgement should guide the interpretation of CAS results.
Measured: At baseline, 3, 6 and 12 months from the recruitment
CSS
Measured by the Covid-19 Stress Scale (CSS) (Taylor et al., 2020), a 36-item scale developed to better understand and assess Covid-19-related distress. The subscales assess symptoms of Covid-related stress and anxiety: (1) fear of danger and contamination, (2) fear of economic consequences, (3) xenophobia, (4) compulsive control and reassurance seeking, and (5) symptoms of traumatic stress on Covid-19. The scales were found to be robust on various reliability and validity indices. The scales are intercorrelated, providing evidence of a Covid-19-related stress syndrome. The scales are promising as tools to better understand the distress associated with Covid-19 and to identify persons in need of mental health services.
Measured: At baseline, 3, 6 and 12 months from the recruitment
BIPQ
Detected with the Brief Illness Perception Questionnaire (BIPQ) (Broadbent et al., 2006), a nine-item scale designed to rapidly assess cognitive and emotional representations of illness.
Measured: At baseline, 3, 6 and 12 months from the recruitment
ICQ
Illness Cognition Questionnaire (ICQ) (Evers et al., 2001), which evaluates three ways of cognitively assessing the stressful and adverse nature of a chronic illness: helplessness, acceptance and perceived benefits.
Measured: At baseline, 3, 6 and 12 months from the recruitment
Anxiety
Measured through the use of the Hospital Anxiety and Depression Scale (HADS) test (Zigmond \& Snaith, 1983), a widely used instrument to measure psychological morbidity in chronically ill patients, which consists of 14 items designed to detect the presence of anxiety and depression.
Measured: At baseline, 3, 6 and 12 months from the recruitment
Depression
Measured through the use of the Hospital Anxiety and Depression Scale (HADS) test (Zigmond \& Snaith, 1983), a widely used instrument to measure psychological morbidity in chronically ill patients, which consists of 14 items designed to detect the presence of anxiety and depression.
Measured: At baseline, 3, 6 and 12 months from the recruitment
Illness Expectations
Some questions specifically formulated to assess explicit disease expectations in heart disease are proposed. These questions will be integrated by the administration of a semi-structured interview.
Measured: At baseline, 3, 6 and 12 months from the recruitment
Socio-demographic data
Date of birth, gender, education, current or previous occupation, marital status, presence of children, smoking, physical activity, presence of heart disease in the family.
Measured: At baseline
Clinical data
Weight and height (for the calculation of Body Mass Index, BMI), blood pressure, heart rate, oxygen saturation, blood test results (complete lipid profile, blood glucose, glycated haemoglobin), co-morbidities, perceived symptoms (breathlessness, chest pressure, angina pectoris, sweating, fainting, nausea, vomiting) acute or elective indication for surgery (specify if patient treated percutaneously or cardiac surgery); post-acute destination (patient discharged home, started on a rehabilitation programme, other); haemodialysis; PCSK9; left ventricular ejection fraction data; reports (coronary angiography, echocardiogram), having contracted Covid-19; presence of asthenia and/or dyspnoea.
Measured: At baseline, 3, 6 and 12 months from the recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start18 May 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseasesStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Valduce Hospital, Azienda Ospedaliera Niguarda Cà Granda
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530472
- Sponsor's protocol ID
- FDG_88-15
- Acronym
- RACAT-COVID
- Status last verified
- Feb 2024
- First submitted
- 29 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.
PubMed 16731240Evers AW, Kraaimaat FW, van Lankveld W, Jongen PJ, Jacobs JW, Bijlsma JW. Beyond unfavorable thinking: the illness cognition questionnaire for chronic diseases. J Consult Clin Psychol. 2001 Dec;69(6):1026-36.
PubMed 11777106Miyazaki M, Nakashima A, Nakamura Y, Sakamoto Y, Matsuo K, Goto M, Uchiyama M, Okamura K, Mitsutake R, Urata H, Kamimura H, Imakyure O. Association between medication adherence and illness perceptions in atrial fibrillation patients treated with direct oral anticoagulants: An observational cross-sectional pilot study. PLoS One. 2018 Sep 28;13(9):e0204814. doi: 10.1371/journal.pone.0204814. eCollection 2018.
PubMed 30265710Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.
PubMed 16079372
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Belief, Expectation, and Adherence to Therapy During COVID-19 Pandemic: a Multigroup Cohort Study in Patients With Ischemic Heart Disease
- ClinicalTrials.gov ID
- NCT06530472
- Acronym / sponsor ID
- RACAT-COVID / FDG_88-15
- Conditions
- Ischemic Heart Diseases
- Keywords
- Ischemic Heart Disease, Adherence, Belief, Acceptance, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Valduce Hospital, Azienda Ospedaliera Niguarda Cà Granda
- Study start
- 18 May 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this [type of study: observational study or clinical trial ] is to learn about, test, compare etc.] in [ describe participant population/health conditions ]. The main question [ it aims to answer are:
- [question
- [question Participants will [describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items ].
If there is a comparison group: Researchers will compare insert groups ] to see if insert effects
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fondazione Don Carlo Gnocchi | – | Other: MonitoringAll patients diagnosed with ischaemic heart disease established by angiography; attained age of majority; Score >= 26 on the Montreal Cognitive Assessment (MoCA) test. At baseline, 3, 6 and 12 months, people will undergo to both a psychological and cardiological assessment. |
| Ospedale Valduce | – | Other: MonitoringAll patients diagnosed with ischaemic heart disease established by angiography; attained age of majority; Score >= 26 on the Montreal Cognitive Assessment (MoCA) test. At baseline, 3, 6 and 12 months, people will undergo to both a psychological and cardiological assessment. |
| Ospedale Cà Granda Niguarda | – | Other: MonitoringAll patients diagnosed with ischaemic heart disease established by angiography; attained age of majority; Score >= 26 on the Montreal Cognitive Assessment (MoCA) test. At baseline, 3, 6 and 12 months, people will undergo to both a psychological and cardiological assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with ischaemic heart disease established by angiography
Key inclusion criteria (3 listed)
- all patients diagnosed with ischaemic heart disease established by angiography;
- reaching the age of majority;
- score >= 26 on the Montreal Cognitive Assessment (MoCA) test (Nasreddine et al., 2005).
Key exclusion criteria (4 listed)
- presence of comorbidity with other pathologies in an active or advanced phase; -patients with a prognosis to be defined;
- pregnancy;
- participants with neurological pathologies that significantly impair their cognitive functions (e.g. advanced Parkinson's disease; Alzheimer's dementia...cardiac arrest with hypoxic damage);
- participants with cognitive impairments that compromise comprehension and sharing of the contents of the questions, detected through the administration of the Montreal Cognitive Assessment (MoCA) test (Nasreddine et al., 2005).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MonitoringAt baseline, 3, 6 and 12 months, people will undergo to both a psychological and cardiological assessment. | Other | Fondazione Don Carlo Gnocchi, Ospedale Cà Granda Niguarda, Ospedale Valduce |
Primary outcome
Adherence
Time frame: At baseline, 3, 6 and 12 months from the recruitment
Measured by the percentage of days covered (Percentage of Days Covered, PDC) by antiplatelet therapy, beta-blockers, statins, ACE-I/Sartan, hypoglycaemic drugs, psychotropic drugs (anxiolytics; antidepressants). The PDC is defined as the proportion of days for which a patient has a supply of medication available. When multiple prescriptions are for the same day, reference is made to the maximum duration, and for overlapping prescriptions, sequential use of the two prescriptions is assumed by summing the days of supply for each. Any interruptions in therapy are also taken into account. Non-adherence is defined as a PDC of less than 80%, while non-persistence is defined as a gap in prescriptions of (Direct Oral Anticoagulants or Direct Oral Anticoagulants) DOACs ≥14 days (Yu et al., 2020).
NACE
Time frame: At baseline, 3, 6 and 12 months from the recruitment
Net adverse clinical event or NACE, defined as a composite of all-cause mortality, myocardial infarction, stroke or major haemorrhage. In this case, bleeding is definitive according to the BARC (Bleeding Academic Research Consortium) scale (Mehran et al., 2011).
MARS-i
Time frame: At baseline, 3, 6 and 12 months from the recruitment
Measure with theMARS-5-i questionnaire consists of five questions on forgetting, changing dosage, stopping, skipping, and taking less medication . The score ranges from 5 to 25, where a higher MARS-5-i score indicates higher self-reported adherence. One item assesses unintentional non-adherence and four items assess intentional non-adherence
11 secondary outcomes
Extra visits
Time frame: At baseline, 3, 6 and 12 months from the recruitment
Adherence to pharmacotherapy
Time frame: At baseline, 3, 6 and 12 months from the recruitment
CAS
Time frame: At baseline, 3, 6 and 12 months from the recruitment
CSS
Time frame: At baseline, 3, 6 and 12 months from the recruitment
BIPQ
Time frame: At baseline, 3, 6 and 12 months from the recruitment
ICQ
Time frame: At baseline, 3, 6 and 12 months from the recruitment
Anxiety
Time frame: At baseline, 3, 6 and 12 months from the recruitment
Depression
Time frame: At baseline, 3, 6 and 12 months from the recruitment
Illness Expectations
Time frame: At baseline, 3, 6 and 12 months from the recruitment
Socio-demographic data
Time frame: At baseline
Clinical data
Time frame: At baseline, 3, 6 and 12 months from the recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Background: PubMed 16731240Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.
- Background: PubMed 11777106Evers AW, Kraaimaat FW, van Lankveld W, Jongen PJ, Jacobs JW, Bijlsma JW. Beyond unfavorable thinking: the illness cognition questionnaire for chronic diseases. J Consult Clin Psychol. 2001 Dec;69(6):1026-36.
- Background: PubMed 30265710Miyazaki M, Nakashima A, Nakamura Y, Sakamoto Y, Matsuo K, Goto M, Uchiyama M, Okamura K, Mitsutake R, Urata H, Kamimura H, Imakyure O. Association between medication adherence and illness perceptions in atrial fibrillation patients treated with direct oral anticoagulants: An observational cross-sectional pilot study. PLoS One. 2018 Sep 28;13(9):e0204814. doi: 10.1371/journal.pone.0204814. eCollection 2018.
- Background: PubMed 16079372Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
Related trials for Ischemic Heart Diseases
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Not yet recruiting
ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)
Coronary Artery Disease, De Novo Stenosis Lesion
Not yet recruiting
Out-Patient Proactive Observation With Wearable-Assisted Tracking for Cardiovascular Health Management
Chronic Coronary Syndrome
RecruitingObservational study
Mechanical Dyssynchrony and Microvascular Dysfunction by SPECT
Myocardial Blood Flow Reserve, Mechanical Dyssynchrony
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Diseases, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
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 4 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: status not confirmed, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Results are not available in the source record.
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?
Adherence (time frame: At baseline, 3, 6 and 12 months from the recruitment). The study lists 3 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 NCT06530472, which also lists 4 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 31 Jul 2024.