The Relationship Between Belief, Expectation, and Adherence to Therapy During COVID-19 Pandemic
NCT Number: NCT06530472
Acronym: RACAT-COVID
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Ischemic Heart Diseases
Interventions: OTHER: Monitoring
Sponsor: Fondazione Don Carlo Gnocchi Onlus
Collaborators: Ospedale Valduce, Como|Azienda Ospedaliera Niguarda Cà Granda
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 196
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-05-18
Completion Date: 2025-06-30
Locations: IRCCS Fondazione Don Carlo Gnocchi, Milan, MI, 20148, Italy

Summary:
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Primary Outcome Measures: 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)., 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)., 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, At baseline, 3, 6 and 12 months from the recruitment
Secondary Outcome Measures: Extra visits, Number of extra (unplanned) visits, frequency of planned follow-up visits, 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)., 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., 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., 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., 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., 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., 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., 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., 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., 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., At baseline, 3, 6 and 12 months from the recruitment