The Relationship Between Belief, Expectation, and Adherence to Therapy During COVID-19 Pandemic: a Multigroup Cohort Study in Patients With Ischemic Heart Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 196
- Locations
- 1
- Primary Endpoint
- NACE
Study Overview
Brief 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, 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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
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).
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).
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
Secondary Outcomes
- Extra visits(At baseline, 3, 6 and 12 months from the recruitment)
- CAS(At baseline, 3, 6 and 12 months from the recruitment)
- Anxiety(At baseline, 3, 6 and 12 months from the recruitment)
- ICQ(At baseline, 3, 6 and 12 months from the recruitment)
- Adherence to pharmacotherapy(At baseline, 3, 6 and 12 months from the recruitment)
- CSS(At baseline, 3, 6 and 12 months from the recruitment)
- BIPQ(At baseline, 3, 6 and 12 months from the recruitment)
- Clinical data(At baseline, 3, 6 and 12 months from the recruitment)
- Depression(At baseline, 3, 6 and 12 months from the recruitment)
- Illness Expectations(At baseline, 3, 6 and 12 months from the recruitment)
- Socio-demographic data(At baseline)