Prevention and Treatment of Cardiovascular Disease (VPC)

May 13, 2024 updated by: Irene Cappadona, IRCCS Centro Neurolesi "Bonino-Pulejo"

Prevention and Treatment of Cardiovascular Disease: Protocol for the Assessment of Psychological, Neuropsychological Implications and Associated Disorders in Cardiology Patients

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The study design is observational and is planned to last approximately 24 months. The overall duration will be related to the time required for enrollment of all planned subjects, data analysis and publication of results.

The study aims to analyze and investigate the most common comorbidities in patients with cardiovascular disease. In addition, a specific focus will be devoted to the caregiver, who plays a key role for the cardiopathic patient.

In detail, the objectives of the project are:

  1. Evaluate the connection between cardiovascular disease and cognitive deficits;
  2. Evaluate the main psychopathologies related to cardiovascular diseases (anxiety, depression);
  3. Evaluate conditions and disorders associated with cardiovascular diseases (dysphagia, pneumophonic coordination disorders, respiratory sleep disorders);
  4. Evaluate the effectiveness of psychoeducational intervention;
  5. Evaluate the impact of cardiovascular disease on the caregiver.

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 is 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.

Inclusion criteria:

  • 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.

Exclusion Criteria:

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

Each patient who is eligible for this study will be presented with the purpose of the study and will freely decide whether to join. Only after the patient, or his/her Legal Representative, has agreed to participate in the investigation and signed the informed consent, can the Investigator proceed with the planned activities, detailed below.

The patient's pathway should unfold as follows:

Each patient's clinical data will be shared from a database, accessible to study collaborators through previously assigned login credentials. After checking inclusion and exclusion criteria and signing informed consents, patients will be taken on.

  1. Baseline Examination.

    • Verification of inclusion and exclusion criteria;
    • Collection of demographic data;
    • Collection of the patient's clinical history;
    • Collection of information about the history of specific pathology and comorbidities.

    Thereafter, standardized tests for psychological, neuropsychological and associated clinical conditions will be administered. In addition, there will be at least one psychoeducation meeting that can also be conducted in groups. The following tests will be administered:

    • SF 36 Questionnaire or SF 12 Questionnaire;
    • MaugerI CaRdiac preventiOn-Questionnaire (MICRO-Q);
    • Mini-mental state examnation (MMSE);
    • Beck's Depression Inventory (BDI);
    • Beck's Anxiety Inventory (BAI);
    • Zarit Burden Inventory (ZBI);
    • Eat-10 test for monitoring swallowing ability and/or Swallowing Disturbance Questionnaire (SDQ).
    • STOPBANG questionnaire and/or 2ABN3M score;
    • Voice assessment using GIRBAS Scale and VHI. Feasibility will be assessed by considering adherence to the monitoring program through testicular assessments that will be performed not only at the baseline visit (T0) but also at the six-month follow-up (T1).
  2. Follow-up visit. For each patient, the assessment tests will be repeated at the same time as the periodic follow-up visits.

Study Type

Observational

Enrollment (Estimated)

218

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Sicilia
      • Messina, Sicilia, Italy, 98066
        • Recruiting
        • Irccs Centro Neurolesi Bonino Pulejo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effectiveness of psychoeducation
Time Frame: 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Centro Neurolesi "Bonino-Pulejo"

Investigators

  • Principal Investigator: Irene Cappadona, IRCCS Centro Neurolesi "Bonino-Pulejo"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2024

Primary Completion (Estimated)

May 13, 2026

Study Completion (Estimated)

May 13, 2026

Study Registration Dates

First Submitted

May 9, 2024

First Submitted That Met QC Criteria

May 13, 2024

First Posted (Actual)

May 14, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 13, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe