Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413823
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-09
Brief Title:
Prevention and Treatment of Cardiovascular Disease
Sponsor:
IRCCS Centro Neurolesi Bonino-Pulejo
Organization:
IRCCS Centro Neurolesi Bonino-Pulejo
Study Overview
Official Title:
Prevention and Treatment of Cardiovascular Disease Protocol for the Assessment of Psychological Neuropsychological Implications and Associated Disorders in Cardiology Patients
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VPC
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 patients quality of life and interfere with the performance of daily activities this research study aims to evaluate the patients functioning in an integrated manner to achieve a holistic view of the health and well-being of the patient and caregiver
By identifying additional often underestimated altered functions that may affect the patients quality of life and interfere with the performance of daily activities this research study aims to evaluate the patients functioning in an integrated manner to achieve a holistic view of the health and well-being of the patient and caregiver
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 UOSD Cardiology with NICU PO Piemonte in Messina will participate in the survey Statistical power analysis was performed using GPower software for a linear regression test assuming a slope H1 of 02 with a significance level α of 005 and a power 1 - β of 085 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 mildmoderate 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 hisher 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 patients pathway should unfold as follows
Each patients 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 patients 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
Becks Depression Inventory BDI
Becks Anxiety Inventory BAI
Zarit Burden Inventory ZBI
Eat-10 test for monitoring swallowing ability andor Swallowing Disturbance Questionnaire SDQ
STOPBANG questionnaire andor 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
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 UOSD Cardiology with NICU PO Piemonte in Messina will participate in the survey Statistical power analysis was performed using GPower software for a linear regression test assuming a slope H1 of 02 with a significance level α of 005 and a power 1 - β of 085 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 mildmoderate 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 hisher 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 patients pathway should unfold as follows
Each patients 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 patients 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
Becks Depression Inventory BDI
Becks Anxiety Inventory BAI
Zarit Burden Inventory ZBI
Eat-10 test for monitoring swallowing ability andor Swallowing Disturbance Questionnaire SDQ
STOPBANG questionnaire andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None