Cardiac Rehabilitation
Conditions
Keywords
Secondary Prevention, Women's cardiovascular disease, case management
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.
Interventions
BEHAVIORALCase Management
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
Sponsors
University of Vermont Medical Center
National Institute of General Medical Sciences (NIGMS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Inclusion Criteria: 1. 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%) 2. Lives in and plans to remain in the greater Burlington, Vermont area for the next year.
Exclusion criteria
1. Severe dementia 2. Advanced cancer, advanced frailty, or other longevity-limiting systemic disease 3. Severe life threatening ventricular arrhythmias unless adequately controlled (e.g. intracardiac defibrillator) 4. Exercise-limiting non-cardiac disease such as severe arthritis, past stroke leading to paralysis 5. Participation in cardiac rehab within the past year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attendance at CR | Within 4 months of discharge | Did the participant attend at least one session of CR within 4 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of CR Sessions Attended | Within 4 months | Number of CR sessions completed within the 4 months |
Countries
United States
Participant flow
Recruitment details
Patients were enrolled at UVMMC Medical Center and Outpatient Cardiology Clinic
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 67.4 Years STANDARD_DEVIATION 10.53 |
| Current smoking | 18 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fitness (METS) | 5.5 METS STANDARD_DEVIATION 2.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 48 Participants |
| Region of Enrollment United States | 109 Participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 56 |
| other Total, other adverse events | 0 / 53 | 0 / 56 |
| serious Total, serious adverse events | 0 / 53 | 0 / 56 |
Outcome results
None listed