NCT03474185

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 2.5-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 (i.e., 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 28, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2021

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

1.1 years

First QC Date

February 28, 2018

Last Update Submit

May 8, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in Knowledge about Coronary Artery Disease (CAD)

    Coronary Artery Disease Education Questionnaire-II (CADE-Q-SV) (de Melo Ghisi, Grace, Thomas, Evans, \& Oh, 2015) * Questionnaire consisting of 20 True/False Items * Assesses knowledge about cardiac physiology, risk factors, exercise, nutrition, and psychosocial risk * Specifically designed to assess patients' knowledge during CR. Good psychometric properties. * The investigators will slightly modify content to ensure match with education classes. * Residualized change scores will be calculated to determine change in knowledge about CAD from pre- to post- cardiac education, and from post-education to 12-weeks (i.e., after CR exercise is complete)

    Patients will complete the CADE-Q-SV at three time points: (T1) after referral to CR but prior to starting cardiac education classes, (T2) immediately following completion of education classes; and (T3) 12-weeks post-education classes

Secondary Outcomes (2)

  • Changes in Beliefs and Attitudes about CR

    Patients will complete the BACR at three time points: (T1) after referral to CR but prior to starting cardiac education classes, (T2) immediately following completion of education classes; and (T3) 12-weeks post-education classes

  • CR adherence

    CR adherence will be measured 12-weeks following the completion of the cardiac education classes (after CR exercise is complete)

Study Arms (1)

Single Cohort

The intervention for the entire cohort will be "Taking Charge of your Heart Health" Cardiac Education Classes, delivered via four 2.5-hour group-based classes at TotalCardiology Rehabilitation in Calgary, Canada. Classes review physiology, risk factors, medications, nutrition, exercise, and stress management. Patients are required to complete these classes prior to starting CR exercise sessions.

Behavioral: Taking Charge of your Heart Health patient education classes

Interventions

"Taking Charge of your Heart Health" patient education classes held at TotalCardiology cardiac rehabilitation in Calgary, Canada. Consists of four, 2.5-hour long group-based classes focused on focused on physiology, risk factors, medications, nutrition, exercise, and stress management

Single Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

English-speaking adults (≥18 years old) with coronary artery disease following an acute coronary syndrome event automatically referred to an outpatient CR program (TotalCardiology Rehabilitation; TCR) in Calgary, Canada

You may qualify if:

  • Referred to and eligible for the TotalCardiology CR program following a diagnosis of acute coronary syndrome (ACS). ACS patients will be targeted in this study because (a) they represent the most common patient group referred to TotalCardiology (\~70% of referrals) and (b) patients with ACS follow an "Early Cardiac Access Clinic" stream at TCR that involves a different schedule of exercise appointments than other patient groups. Therefore recruiting ACS patients will enable a consistent CR referral and intake process across all study participants.
  • Provided consent to be contacted about research studies
  • Provided informed consent to participate in the study

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behavioural Medicine Laboratory

Calgary, Alberta, T2N 1N4, Canada

Location

MeSH Terms

Conditions

Coronary Artery DiseaseAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Tavis S Campbell, PhD.

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 22, 2018

Study Start

May 28, 2018

Primary Completion

July 1, 2019

Study Completion

March 2, 2021

Last Updated

May 9, 2023

Record last verified: 2023-05

Locations