Early Case Management on Recovery From a Cardiac Event in Women

NCT ID: NCT04693988

Last Updated: 2023-12-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-18
• Study Completion Date: 2024-12-01

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.

Conditions

Cardiac Rehabilitation

Keywords

Secondary Prevention, Women's cardiovascular disease, case management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Case management

Patient receives case management while in hospital.

Group Type: EXPERIMENTAL

Case Management

Intervention Type: 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

Usual Care

This control condition does not receive intervention of case management

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Case 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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: collaborator

University of Vermont Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sherrie Khadanga

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Vermont Medical Center

Burlington, Vermont, United States

Countries

United States

Other Identifiers

P20GM103644

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00001090

Identifier Type: -

Identifier Source: org_study_id