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OpenTrials
Completed

NCT Number: NCT04693988

Early Case Management on Recovery From a Cardiac Event in Women

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Vermont Medical Center

Burlington, Vermont, 05405, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Case Management

Behavioral

a case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as provide advice about cardiac symptoms and behavioral life style changes

Primary outcomes

  1. Attendance at CR

    Time frame: Within 4 months of discharge

    Did the participant attend at least one session of CR within 4 months

Secondary outcomes

  1. Number of CR Sessions Attended

    Time frame: Within 4 months

    Number of CR sessions completed within the 4 months

Sponsors and collaborators

Lead sponsor

University of Vermont Medical Center

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jan 5, 2021
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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