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Clinical Trials/NCT04693988
NCT04693988
Active, not recruiting
Not Applicable

Early Case Management on Recovery From a Cardiac Event in Women

University of Vermont Medical Center1 site in 1 country113 target enrollmentJanuary 18, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Rehabilitation
Sponsor
University of Vermont Medical Center
Enrollment
113
Locations
1
Primary Endpoint
Cardiac Rehabilitation Participation
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

Outpatient cardiac rehabilitation (CR) is an exercise-based lifestyle program for patients who have experienced a myocardial infarction, systolic heart failure, percutaneous revascularization or cardiac surgery. CR plays a key role in secondary prevention, which is the prevention of subsequent cardiac events. CR has been shown to reduce both cardiovascular mortality and one year hospital readmissions as well as improve quality of life, exercise capacity, and physical function. Although the benefits have been clearly established for cardiac patients, women are much less likely to attend CR than men. Based upon our own preliminary data (and the medical literature), attendance at CR is determined by factors that vary in their importance between men and women. These findings demonstrate that older age and poor social support are particular barriers to CR participation in women. This information can guide efforts to increase CR participation and adherence in women, areas which have received little study.

Case management (CM) has been effective at reducing cardiovascular risk and reducing hospitalizations amongst cardiac patients. Further, CM has been effective at promoting attendance in a variety of health related programs (for example, diabetes treatment or cocaine dependence treatment). The primary aim in this randomized controlled trial is to examine the efficacy of early CM to promote participation and adherence in CR. The CM model can identify individualized determinants of health and social needs to identify potential barriers which may hinder CR enrollment. Additionally, the case manager will conduct a home visit and provide individual counseling to address lifestyle changes including physical activity. Thus, a component of CR and physical activity can be still be delivered for those unable to attend CR. The concept of CM to improve CR participation and adherence has not been specifically tested in women, a vulnerable patient population. This intervention, therefore, has the potential to increase utilization of CR and significantly improve health outcomes in female cardiac patients.

Registry
clinicaltrials.gov
Start Date
January 18, 2021
End Date
December 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sherrie Khadanga

Assistant Professor of Medicine

University of Vermont Medical Center

Eligibility Criteria

Inclusion Criteria

  • Inclusion Criteria:
  • A cardiac rehabilitation qualifying condition including: A recent myocardial infarction or coronary revascularization or heart valve replacement or repair, stable angina, or congestive heart failure (ejection fraction \<35%)
  • Lives in and plans to remain in the greater Burlington, Vermont area for the next year.

Exclusion Criteria

  • Severe dementia
  • Advanced cancer, advanced frailty, or other longevity-limiting systemic disease
  • Severe life threatening ventricular arrhythmias unless adequately controlled (e.g. intracardiac defibrillator)
  • Exercise-limiting non-cardiac disease such as severe arthritis, past stroke leading to paralysis
  • Participation in cardiac rehab within the past year

Outcomes

Primary Outcomes

Cardiac Rehabilitation Participation

Time Frame: within 4 months of the intake assessment

Attendance of at least 1 session

Cardiac Rehabilitation Adherence

Time Frame: within 4 months of the intake assessment

Number of cardiac rehabilitation sessions completed out of a possible 36

Secondary Outcomes

  • Changes in Depression(within 4 months of the intake assessment)
  • Changes in Anxiety(within 4 months of the intake assessment)
  • Changes in Physical Activity(within 4 months of the intake assessment)
  • Changes in Self Reported Physical Function(within 4 months of the intake assessment)
  • Changes in Quality of Life(within 4 months of the intake assessment)

Study Sites (1)

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