Early Case Management on Recovery From a Cardiac Event in Women
- Conditions
- Cardiac Rehabilitation
- Interventions
- Behavioral: Case Management
- Registration Number
- NCT04693988
- Lead Sponsor
- University of Vermont Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 113
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Case management Case Management Patient receives case management while in hospital.
- Primary Outcome Measures
Name Time Method Cardiac Rehabilitation Participation within 4 months of the intake assessment Attendance of at least 1 session
Cardiac Rehabilitation Adherence within 4 months of the intake assessment Number of cardiac rehabilitation sessions completed out of a possible 36
- Secondary Outcome Measures
Name Time Method Changes in Depression within 4 months of the intake assessment Changes in depression (Patient Health Questionnaire-9) will be measured from intake to completion of the intervention (4 months after intake)
Changes in Anxiety within 4 months of the intake assessment Changes in anxiety (Generalized Anxiety Disorder questionnaire) will be measured from intake to completion of the intervention (4 months after intake)
Changes in Physical Activity within 4 months of the intake assessment Changes in fitness level (step count) will be measured from intake to completion of the intervention (4 months after intake)
Changes in Self Reported Physical Function within 4 months of the intake assessment 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)
Changes in Quality of Life within 4 months of the intake assessment Changes in perceived quality of life (MacNew) questionnaires will be measured from intake to completion of the intervention (4 months after intake)
Trial Locations
- Locations (1)
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States