Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06413823 |
| Other study ID # |
08/2024 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 9, 2024 |
| Est. completion date |
May 13, 2026 |
Study information
| Verified date |
May 2024 |
| Source |
IRCCS Centro Neurolesi "Bonino-Pulejo" |
| Contact |
Irene Cappadona, psychologist |
| Phone |
3274409990 |
| Email |
irene.cappadona[@]irccsme.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
