Early Case Management on Recovery From a Cardiac Event in Women

Study Overview
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Brief Summary
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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.

Official Title
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Early Case Management on Recovery From a Cardiac Event in Women

Conditions
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Cardiac Rehabilitation

Intervention / Treatment
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* Behavioral: Case Management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Case management<br>Patient receives case management while in hospital. | Behavioral: Case Management<br>* 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<br>|
| No Intervention: Usual Care<br>This control condition does not receive intervention of case management | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Rehabilitation Participation | Attendance of at least 1 session | within 4 months of the intake assessment | 
| Cardiac Rehabilitation Adherence | Number of cardiac rehabilitation sessions completed out of a possible 36 | within 4 months of the intake assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Physical Activity | Changes in fitness level (step count) will be measured from intake to completion of the intervention (4 months after intake) | within 4 months of the intake assessment | 
| Changes in Quality of Life | Changes in perceived quality of life (MacNew) questionnaires will be measured from intake to completion of the intervention (4 months after intake) | within 4 months of the intake assessment | 
| Changes in Self Reported Physical Function | Changes in perceived physical function (Medical Outcomes Study Short Form-36) will be measured from intake to completion of the intervention (4 months after intake) | within 4 months of the intake assessment | 
| Changes in Depression | Changes in depression (Patient Health Questionnaire-9) will be measured from intake to completion of the intervention (4 months after intake) | within 4 months of the intake assessment | 
| Changes in Anxiety | Changes in anxiety (Generalized Anxiety Disorder questionnaire) will be measured from intake to completion of the intervention (4 months after intake) | within 4 months of the intake assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Secondary Prevention, Women's cardiovascular disease, case management