The Relationship Between Belief, Expectation, and Adherence to Therapy During COVID-19 Pandemic
- Conditions
- Ischemic Heart Diseases
- Interventions
- Other: Monitoring
- Registration Number
- NCT06530472
- Lead Sponsor
- Fondazione Don Carlo Gnocchi Onlus
- Brief Summary
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- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 196
- 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).
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Fondazione Don Carlo Gnocchi Monitoring 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. Ospedale Valduce Monitoring 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. Ospedale Cà Granda Niguarda Monitoring 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.
- Primary Outcome Measures
Name Time Method NACE 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).
Adherence 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).MARS-i 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
- Secondary Outcome Measures
Name Time Method Extra visits At baseline, 3, 6 and 12 months from the recruitment Number of extra (unplanned) visits, frequency of planned follow-up visits
CAS At baseline, 3, 6 and 12 months from the recruitment 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.
Anxiety At baseline, 3, 6 and 12 months from the recruitment 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.
ICQ At baseline, 3, 6 and 12 months from the recruitment 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.
Adherence to pharmacotherapy At baseline, 3, 6 and 12 months from the recruitment 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).CSS At baseline, 3, 6 and 12 months from the recruitment 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.
BIPQ At baseline, 3, 6 and 12 months from the recruitment 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.
Clinical data At baseline, 3, 6 and 12 months from the recruitment 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.
Depression At baseline, 3, 6 and 12 months from the recruitment 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.
Illness Expectations At baseline, 3, 6 and 12 months from the recruitment 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.
Socio-demographic data At baseline Date of birth, gender, education, current or previous occupation, marital status, presence of children, smoking, physical activity, presence of heart disease in the family.
Trial Locations
- Locations (1)
IRCCS Fondazione Don Carlo Gnocchi
🇮🇹Milan, MI, Italy