Ignite Creation Date:
2024-05-06 @ 5:53 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05461729
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-21
First Post:
2022-07-13
Brief Title:
TIMELY Prospective Study
Sponsor:
Dr Boris Schmitz
Organization:
University of WittenHerdecke
Study Overview
Official Title:
TIMELY Prospective Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
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:
TIMELY
Brief Summary:
Brief Summary
Cardiac rehabilitation CR is a multi-factorial intervention designed to limit the physiological and psychological effects of cardiovascular disease such as coronary artery disease CAD manage symptoms and reduce the risk of future cardiovascular events CR is a structured program not only addressing CAD but also comorbidities including hypertension dyslipidemia diabetes and obesity as well as other risk factors CR aims at long-term lifestyle changes to reduce modifiable risk factors and its success depends on a large number of interacting variables including biological psychological and social factors Recently the importance of patient-centered approaches to secondary prevention and CR success has been underlined but intra-individual factors and their interactions are not well understood The TIMELY prospective study aims to collect high-resolution data for data mining and artificial intelligence machine learning models to identify dependencies between factors and predict favorable outcomes of CR Data collection will include data documented during controlled center-based CR as well as remote-measurement of physical activity data central blood pressure and pulse wave analysis as well as long-term ECG data during a 6-months period after discharge Follow-up assessments will be performed at least at 6 months and at 12 months after discharge
Main objectives of the study
1 To examine uptake and adherence to a healthy lifestyle i e adherence to CR guidelines in CAD and the effects on long-term outcomes
2 To identify potentially mediating mechanisms and predictive factors for long-term CR success in CAD
3 To investigate acceptance of different eHealth components as well as expectations and needs among CAD patents in CR
Cardiac rehabilitation CR is a multi-factorial intervention designed to limit the physiological and psychological effects of cardiovascular disease such as coronary artery disease CAD manage symptoms and reduce the risk of future cardiovascular events CR is a structured program not only addressing CAD but also comorbidities including hypertension dyslipidemia diabetes and obesity as well as other risk factors CR aims at long-term lifestyle changes to reduce modifiable risk factors and its success depends on a large number of interacting variables including biological psychological and social factors Recently the importance of patient-centered approaches to secondary prevention and CR success has been underlined but intra-individual factors and their interactions are not well understood The TIMELY prospective study aims to collect high-resolution data for data mining and artificial intelligence machine learning models to identify dependencies between factors and predict favorable outcomes of CR Data collection will include data documented during controlled center-based CR as well as remote-measurement of physical activity data central blood pressure and pulse wave analysis as well as long-term ECG data during a 6-months period after discharge Follow-up assessments will be performed at least at 6 months and at 12 months after discharge
Main objectives of the study
1 To examine uptake and adherence to a healthy lifestyle i e adherence to CR guidelines in CAD and the effects on long-term outcomes
2 To identify potentially mediating mechanisms and predictive factors for long-term CR success in CAD
3 To investigate acceptance of different eHealth components as well as expectations and needs among CAD patents in CR
Detailed Description:
None
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