Clinical trial NCT06396793: Psychological Symptoms in Cardiac and Pulmonary Diseases
Official title: Prevalence of Psychological Symptoms and Their Correlation With the Rehabilitative Outcome in Patients With Cardiac and Pulmonary Diseases Undergoing a Hospital Rehabilitation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychological Distress
Anxiety
Depression
Cardiovascular Diseases
Pulmonary Disease
Rehabilitation
Coping Behavior
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 421
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 admitted to the ICS Maugeri Cardiology and Pulmonary Rehabilitation Units

Brief summary: The European guidelines emphasize the importance of conducting psychological screenings to investigate the presence of stress and symptoms of anxiety and depression in patients with cardiovascular disease: depression, common among patients with CVD, is associated with increased mortality, disability, decreased adherence to healthy lifestyles and medical treatments, and together with anxiety, the risk of mortality increases by about 3 times; stress, furthermore, is associated with the development and progression of cardiovascular diseases and is correlated with low adherence and cigarette smoking.

Less studied, but not less important, are the incidence of anxiety, depression, and stress in pulmonary disease, the relationship between mental disorders and pulmonary diseases, as well as the effect of the psychological component on the rehabilitative outcome of such patients: for example, there is evidence that those suffering from chronic obstructive pulmonary disease (COPD) present symptoms of depression and anxiety much more frequently than the general population and that these two mental disorders may exacerbate COPD itself.

The literature, therefore, highlights that the risk of onset of cardiovascular disease increases with the severity of mental disorder, and some psychological variables correlate with the outcomes of cardiac rehabilitation intervention, crucial for reducing rehospitalizations, myocardial infarction, and mortality, as well as for improving the patient's quality of life and ability to perform physical exercises.

In light of this evidence and the recent recommendations of the ESC, the present study aims to conduct screening for symptoms of anxiety, depression, and stress in all patients admitted to the Cardiology and Pulmonary Rehabilitation Units of the Milan Center, Camaldoli in order to assess their incidence and to select, through validated tools, patients who require personalized psychological intervention based on their level of risk, correlating then the presence of such symptoms with the rehabilitative outcome, in order to assess how much the mental component interferes with the care pathway. The level of acceptance and feasibility of a computerized data collection procedure will also be evaluated, a procedure that, if well accepted, would make the screening process much simpler, safer, and more economical.


Eligibility criteria: Inclusion Criteria:

* aged≥18
* able to fulfil questionnaires autonomously

Exclusion Criteria:

* no Italian comprehension,
* severe visuoperceptive deficits,
* cognitive deterioration preventing self-completion of questionnaires,
* refusal to underwent to the evaluation

Primary outcomes:
measure: Prevalence of psychological risk and protective factors
timeFrame: 18 months
Secondary outcomes:
measure: Correlations between psychological variables and rehabilitative outcomes
timeFrame: 18 months
measure: Acceptance of computerized screening
timeFrame: 18 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: ICS Maugeri SpA SB
state: MI
Study officials:
affiliation: ICS Maugeri SpA SB
name: Alessandra Gorini, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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