The Relationship Between Belief, Expectation, and Adherence to Therapy During COVID-19 Pandemic

NCT06530472 | Enrolling By Invitation DMC

• 1 other identifier: FDG_88-15
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

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• \[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

Keywords

Ischemic Heart Disease; Adherence; Belief; Acceptance; COVID-19

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• Extra visits

  At baseline, 3, 6 and 12 months from the recruitment

• Adherence to pharmacotherapy

  At baseline, 3, 6 and 12 months from the recruitment

• CAS

  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

Study Arms (3)

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.

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.

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.

Other: Monitoring

Interventions

Monitoring OTHER

At baseline, 3, 6 and 12 months, people will undergo to both a psychological and cardiological assessment.

Fondazione Don Carlo Gnocchi; Ospedale Cà Granda Niguarda; Ospedale Valduce

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients diagnosed with ischaemic heart disease established by angiography

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Ospedale Valduce, Como: collaborator
• Azienda Ospedaliera Niguarda Cà Granda: collaborator

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi

Milan, MI, 20148, Italy

Location

Related Publications (4)

• 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.

  PMID: 16731240 BACKGROUND

• Evers 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.

  PMID: 11777106 BACKGROUND

• Miyazaki 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.

  PMID: 30265710 BACKGROUND

• Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.

  PMID: 16079372 BACKGROUND

MeSH Terms

Conditions

Myocardial Ischemia; COVID-19

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: July 31, 2024
• Study Start: May 18, 2021
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)