Ignite Creation Date:
2024-05-06 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03474185
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2018-02-28
Brief Title:
The IMPART Study The Impact of Patient Education in Cardiac Rehabilitation
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Evaluating the Impact of Patient Education on Knowledge Attitudes and Adherence in Cardiac Rehabilitation Patients
Status:
COMPLETED
Status Verified Date:
2023-05
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:
None
Brief Summary:
Background
Exercise-based cardiac rehabilitation CR is the gold-standard in tertiary prevention of coronary artery disease CAD yet average CR attendance is only 67 Patient education is commonly delivered during CR to impart information about CAD and its risk factors An underlying assumption is that knowledge will enhance patients attitudes toward CR promote better program adherence and improve clinically relevant cardiovascular outcomes However more formative work is needed to characterize the impact of patient education delivered in a CR setting on purported mechanisms-of-action in order to optimize efficacy Few cardiac patient education interventions have been empirically validated and it is unclear whether knowledge gains from education translate to improved CR attitudes and program adherence
Objective This study aims to 1 examine the association between cardiac patient education and changes in knowledge about CAD and 2 explore whether changes in knowledge correspond to a improved attitudes about CR perceived necessity concerns about exercise practical barriers perceived personal suitability and b increased CR adherence
Hypothesis It is expected that 1 knowledge will increase from pre- to post-patient education and 2 knowledge gains will be associated with improved CR attitudes and better CR adherence
Methods 100 adults with CAD referred to outpatient CR will be recruited prior to attending four mandatory 25-hour-long group-based education classes Patients will subsequently attend supervised CR exercise sessions twice-weekly for 12 weeks Validated questionnaires assessing knowledge about CAD and attitudes toward CR ie perceived necessity exercise concerns barriers perceived suitability will be completed pre- and post-cardiac education classes and 12-weeks post-CR Adherence of CR exercise sessions attended will be obtained by chart review
Implications This study will help identify whether patient education delivered in a CR setting impacts hypothesized treatment targets and inform future efforts to optimize behavioral interventions for increasing CR utilization
Exercise-based cardiac rehabilitation CR is the gold-standard in tertiary prevention of coronary artery disease CAD yet average CR attendance is only 67 Patient education is commonly delivered during CR to impart information about CAD and its risk factors An underlying assumption is that knowledge will enhance patients attitudes toward CR promote better program adherence and improve clinically relevant cardiovascular outcomes However more formative work is needed to characterize the impact of patient education delivered in a CR setting on purported mechanisms-of-action in order to optimize efficacy Few cardiac patient education interventions have been empirically validated and it is unclear whether knowledge gains from education translate to improved CR attitudes and program adherence
Objective This study aims to 1 examine the association between cardiac patient education and changes in knowledge about CAD and 2 explore whether changes in knowledge correspond to a improved attitudes about CR perceived necessity concerns about exercise practical barriers perceived personal suitability and b increased CR adherence
Hypothesis It is expected that 1 knowledge will increase from pre- to post-patient education and 2 knowledge gains will be associated with improved CR attitudes and better CR adherence
Methods 100 adults with CAD referred to outpatient CR will be recruited prior to attending four mandatory 25-hour-long group-based education classes Patients will subsequently attend supervised CR exercise sessions twice-weekly for 12 weeks Validated questionnaires assessing knowledge about CAD and attitudes toward CR ie perceived necessity exercise concerns barriers perceived suitability will be completed pre- and post-cardiac education classes and 12-weeks post-CR Adherence of CR exercise sessions attended will be obtained by chart review
Implications This study will help identify whether patient education delivered in a CR setting impacts hypothesized treatment targets and inform future efforts to optimize behavioral interventions for increasing CR utilization
Detailed Description:
BACKGROUND RATIONALE
Cardiovascular disease which includes coronary artery disease CAD is a leading cause of death in Canada and worldwide Cardiac rehabilitation CR is the gold standard intervention for tertiary prevention of CAD and is associated with improvements in cardiovascular risk eg blood pressure psychological distress and with 26 reductions in mortality Despite these benefits only 20-50 of eligible patients participate and even fewer attend all scheduled CR sessions CR consists of multicomponent risk reduction interventions including exercise training and patient education PE An underlying assumption of PE is that imparting knowledge to patients will lead to changes in their adherence to health behaviours and ultimately influence cardiovascular outcomes Decades of research from behavioural science however demonstrates that changing health behaviours such as CR participation requires more than knowing what to do but also favourable attitudes and self-efficacy about behaviour change PE has been demonstrated to enhance knowledge about CAD but more work is needed to understand whether changes in knowledge translate into more positive attitudes self-efficacy and adherence to CR To date only one Canadian PE curriculum within a CR setting has been empirically evaluated and cardiac PE classes across settings are often poorly described and variable in duration and format To optimize adherence to CR and its associated survival benefits there is a need to evaluate whether a well-described cardiac PE curriculum helps translate knowledge into favourable attitudes self-efficacy and CR attendance
PRIMARY AIM To determine the impact of a Calgary-based patient education curriculum delivered in a CR setting ie Taking Charge of your Heart Health TCHH on cardiac knowledge post-TCHH and at 12-week follow-up
SECONDARY AIMS
To examine the impact of cardiac education on attitudes toward CR and self-efficacy for CR attendance from pre- to post-TCHH
To examine whether increases in CAD knowledge are associated with improvements in attitudes toward CR self-efficacy for CR adherence from pre- to post-TCHH oTo examine whether increases in CAD knowledge from pre- to post-TCHH are associated with CR adherence
HYPOTHESES It is predicted that 1 knowledge about CAD will increase from pre- to post-TCHH and knowledge gains will be maintained at 12-weeks and 2 increases in knowledge will be positively associated with improvements in attitudes toward CR self-efficacy toward CR participation and actual CR adherence
METHODS
DESIGN This is a prospective observational cohort study As the cardiac education intervention is a mandatory component of participation in the CR program the present study will observe and measure changes in CAD knowledge CR attitudes and CR adherence among eligible CR patients who choose to participate
CR PROGRAM The CR program consists of four mandatory 25-hour group-based cardiac education classes focused on physiology risk factors medications nutrition exercise and stress management followed by 12 weeks of supervised exercise training held twice weekly All patients enrolled in the CR program are required to complete the 4 education classes prior to starting CR exercise
PROCEDURE
Patients will complete a baseline battery of validated questionnaires assessing CAD knowledge CR attitudes and CR self-efficacy as well as baseline demographic and medical information prior to their first TCHH class T1 Measures of CAD knowledge CR attitudes and CR self-efficacy will be re-administered post-TCHH T2 and after completion of CR exercise training 12-weeks T3
DATA ANALYSIS To evaluate the impact of patient education on knowledge a repeated-measures ANOVA will be performed with time as the independent variable T1 T2 T3 and CAD knowledge as the dependent variable To evaluate the association between knowledge gains and CR attitudes self-efficacy and CR adherence residualized change scores will be calculated for T1 to T2 knowledge attitudes and self-efficacy The investigators will conduct separate regression models with knowledge change scores as the independent variable and with CR attitudes change scores and CR adherence as dependent variables
IMPLICATIONS This study will inform strategies to help increase knowledge and translate knowledge into exercise adherence among patients with CAD Given the link between CR attendance and morbiditymortality efforts to optimize patient education interventions and CR utilization have the potential to significantly improve cardiovascular health outcomes
Cardiovascular disease which includes coronary artery disease CAD is a leading cause of death in Canada and worldwide Cardiac rehabilitation CR is the gold standard intervention for tertiary prevention of CAD and is associated with improvements in cardiovascular risk eg blood pressure psychological distress and with 26 reductions in mortality Despite these benefits only 20-50 of eligible patients participate and even fewer attend all scheduled CR sessions CR consists of multicomponent risk reduction interventions including exercise training and patient education PE An underlying assumption of PE is that imparting knowledge to patients will lead to changes in their adherence to health behaviours and ultimately influence cardiovascular outcomes Decades of research from behavioural science however demonstrates that changing health behaviours such as CR participation requires more than knowing what to do but also favourable attitudes and self-efficacy about behaviour change PE has been demonstrated to enhance knowledge about CAD but more work is needed to understand whether changes in knowledge translate into more positive attitudes self-efficacy and adherence to CR To date only one Canadian PE curriculum within a CR setting has been empirically evaluated and cardiac PE classes across settings are often poorly described and variable in duration and format To optimize adherence to CR and its associated survival benefits there is a need to evaluate whether a well-described cardiac PE curriculum helps translate knowledge into favourable attitudes self-efficacy and CR attendance
PRIMARY AIM To determine the impact of a Calgary-based patient education curriculum delivered in a CR setting ie Taking Charge of your Heart Health TCHH on cardiac knowledge post-TCHH and at 12-week follow-up
SECONDARY AIMS
To examine the impact of cardiac education on attitudes toward CR and self-efficacy for CR attendance from pre- to post-TCHH
To examine whether increases in CAD knowledge are associated with improvements in attitudes toward CR self-efficacy for CR adherence from pre- to post-TCHH oTo examine whether increases in CAD knowledge from pre- to post-TCHH are associated with CR adherence
HYPOTHESES It is predicted that 1 knowledge about CAD will increase from pre- to post-TCHH and knowledge gains will be maintained at 12-weeks and 2 increases in knowledge will be positively associated with improvements in attitudes toward CR self-efficacy toward CR participation and actual CR adherence
METHODS
DESIGN This is a prospective observational cohort study As the cardiac education intervention is a mandatory component of participation in the CR program the present study will observe and measure changes in CAD knowledge CR attitudes and CR adherence among eligible CR patients who choose to participate
CR PROGRAM The CR program consists of four mandatory 25-hour group-based cardiac education classes focused on physiology risk factors medications nutrition exercise and stress management followed by 12 weeks of supervised exercise training held twice weekly All patients enrolled in the CR program are required to complete the 4 education classes prior to starting CR exercise
PROCEDURE
Patients will complete a baseline battery of validated questionnaires assessing CAD knowledge CR attitudes and CR self-efficacy as well as baseline demographic and medical information prior to their first TCHH class T1 Measures of CAD knowledge CR attitudes and CR self-efficacy will be re-administered post-TCHH T2 and after completion of CR exercise training 12-weeks T3
DATA ANALYSIS To evaluate the impact of patient education on knowledge a repeated-measures ANOVA will be performed with time as the independent variable T1 T2 T3 and CAD knowledge as the dependent variable To evaluate the association between knowledge gains and CR attitudes self-efficacy and CR adherence residualized change scores will be calculated for T1 to T2 knowledge attitudes and self-efficacy The investigators will conduct separate regression models with knowledge change scores as the independent variable and with CR attitudes change scores and CR adherence as dependent variables
IMPLICATIONS This study will inform strategies to help increase knowledge and translate knowledge into exercise adherence among patients with CAD Given the link between CR attendance and morbiditymortality efforts to optimize patient education interventions and CR utilization have the potential to significantly improve cardiovascular health outcomes
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