Clinical trial NCT06530472: The Relationship Between Belief, Expectation, and Adherence to Therapy During COVID-19 Pandemic
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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Ischemic Heart Diseases
Keywords: Ischemic Heart Disease
Adherence
Belief
Acceptance
COVID-19
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Ospedale Valduce, Como
name: Azienda Ospedaliera Niguarda Cà Granda
First posted: 2024-07-31
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients diagnosed with ischaemic heart disease established by angiography

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:

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* \[question Participants will \[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items \].

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Eligibility criteria: 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).

Primary outcomes:
measure: Adherence
timeFrame: At baseline, 3, 6 and 12 months from the recruitment
measure: NACE
timeFrame: At baseline, 3, 6 and 12 months from the recruitment
measure: MARS-i
timeFrame: At baseline, 3, 6 and 12 months from the recruitment
Secondary outcomes:
measure: Extra visits
timeFrame: At baseline, 3, 6 and 12 months from the recruitment
measure: Adherence to pharmacotherapy
timeFrame: At baseline, 3, 6 and 12 months from the recruitment
measure: CAS
timeFrame: At baseline, 3, 6 and 12 months from the recruitment
measure: CSS
timeFrame: At baseline, 3, 6 and 12 months from the recruitment
measure: BIPQ
timeFrame: At baseline, 3, 6 and 12 months from the recruitment
measure: ICQ
timeFrame: At baseline, 3, 6 and 12 months from the recruitment
measure: Anxiety
timeFrame: At baseline, 3, 6 and 12 months from the recruitment
measure: Depression
timeFrame: At baseline, 3, 6 and 12 months from the recruitment
measure: Illness Expectations
timeFrame: At baseline, 3, 6 and 12 months from the recruitment
measure: Socio-demographic data
timeFrame: At baseline
measure: Clinical data
timeFrame: At baseline, 3, 6 and 12 months from the recruitment
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Fondazione Don Carlo Gnocchi
state: MI
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.