Clinical trial NCT04693988: Early Case Management on Recovery From a Cardiac Event in Women
Official title: Early Case Management on Recovery From a Cardiac Event in Women
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiac Rehabilitation
Keywords: Secondary Prevention, Women's cardiovascular disease, case management
Lead sponsor: University of Vermont Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2021-01-05
Enrollment: 113
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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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

Primary outcomes:
measure: Cardiac Rehabilitation Participation
timeFrame: within 4 months of the intake assessment
measure: Cardiac Rehabilitation Adherence
timeFrame: within 4 months of the intake assessment
Secondary outcomes:
measure: Changes in Physical Activity
timeFrame: within 4 months of the intake assessment
measure: Changes in Quality of Life
timeFrame: within 4 months of the intake assessment
measure: Changes in Self Reported Physical Function
timeFrame: within 4 months of the intake assessment
measure: Changes in Depression
timeFrame: within 4 months of the intake assessment
measure: Changes in Anxiety
timeFrame: within 4 months of the intake assessment
Other outcomes:
measure: Maintenance of Physical Activity following Intervention
timeFrame: From completion of intervention (4 months) to follow up (one year)
measure: Maintenance of Quality of Life following Intervention
timeFrame: From completion of intervention (4 months) to follow up (one year)
measure: Maintenance of Self Reported Physical Function following Intervention
timeFrame: From completion of intervention (4 months) to follow up (one year)
measure: Maintenance of Depression following Intervention
timeFrame: From completion of intervention (4 months) to follow up (one year)
measure: Maintenance of Anxiety following Intervention
timeFrame: From completion of intervention (4 months) to follow up (one year)
measure: Health Care Contacts
timeFrame: One year period starting at intake assessment
Locations:
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
References: