Prevention and Treatment of Cardiovascular Disease

NCT06413823 | Recruiting DMC

• 1 other identifier: 08/2024
• Study Type: observational
• Target: 218
• Locations: 1 country
• Sites: 1

Brief Summary

In view of the close interrelationship between the various organs and systems of the body, which cannot be examined in a parceled fashion but rather as an integrated system, this study aims to consider the potential risks associated with cardiovascular disease. By identifying additional, often underestimated, altered functions that may affect the patient's quality of life and interfere with the performance of daily activities, this research study aims to evaluate the patient's functioning in an integrated manner to achieve a holistic view of the health and well-being of the patient and caregiver.

Conditions

Cardiovascular Disease

Keywords

Cardiovascular disease; neuropsychological; depression; anxiety; psychoeducation; dysphagia; caregiver; sleep disorders; altered pneumophonic coordination

Outcome Measures

Primary Outcomes (1)

• effectiveness of psychoeducation

  The primary outcome variable considered for calculation is the result of the SF-12 (or SF-36) test as a summary index of the effectiveness of psychoeducation.

  24 months

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A minimum of 218 patients recruited from those afferent at the U.O.S.D. Cardiology with NICU P.O. "Piemonte" in Messina will participate in the survey. Statistical power analysis was performed using G\*Power software for a linear regression test, assuming a slope (H1) of 0.2 with a significance level (α) of 0.05 and a power (1 - β) of 0.85. The primary outcome variable considered for the calculation was the result of the SF-12 (or SF-36) test as a summary index of the effectiveness of psychoeducation. The calculation indicated a sample of 218 subjects as adequate for the purpose of detecting the hypothesized effect

You may qualify if:

• Age between 45 and 85 years;
• Confirmed diagnosis of cardiovascular disease;
• Presence of chronic cardiovascular disease;
• Absence of cognitive impairment or mild/moderate cognitive impairment (Mini Mental Score \>26);
• Patient who has given informed consent personally or through Legal Representative

You may not qualify if:

• \- Presence of severe psychiatric and neurological disorders
• Presence of end-stage oncological disease.
• Severe visual impairment that cannot be corrected by dioptric lenses

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

Irccs Centro Neurolesi Bonino Pulejo

Messina, Sicily, 98066, Italy

RECRUITING

Related Publications (1)

• Cappadona I, Ielo A, Pagano M, Anselmo A, Micali G, Giambo FM, Duca A, D'Aleo P, Costanzo D, Carcione G, Dispenzieri C, Speciale F, Bramanti P, Bramanti A, Garofano M, Corallo F. Observational protocol on neuropsychological disorders in cardiovascular disease for holistic prevention and treatment. Future Cardiol. 2025 May;21(6):349-358. doi: 10.1080/14796678.2025.2483155. Epub 2025 Mar 21.

  PMID: 40117170 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Depression; Anxiety Disorders; Deglutition Disorders; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Irene Cappadona

  IRCCS Centro Neurolesi Bonino Pulejo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Cappadona, psychologist

CONTACT

3274409990; irene.cappadona@irccsme.it

Irene Cappadona

CONTACT

3274409990; irene.cappadona@irccsme.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 14, 2024
• Study Start: May 9, 2024
• Primary Completion: May 13, 2026
• Study Completion: May 13, 2026
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)