Early Case Management on Recovery From a Cardiac Event in Women

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiac Rehabilitation
• Intervention / Treatment: Behavioral: Case Management

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05405
      • University of Vermont Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Case management; Patient receives case management while in hospital.	Behavioral: 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
No Intervention: Usual Care; This control condition does not receive intervention of case management

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maintenance of Physical Activity following Intervention	Changes in step count will be measure from intervention completion until follow-up (8 months after intervention completion)	From completion of intervention (4 months) to follow up (one year)
Maintenance of Quality of Life following Intervention	Changes in perceived quality of life (MacNew questionnaire) will be measured from intervention completion until follow-up (8 months after intervention completion)	From completion of intervention (4 months) to follow up (one year)
Maintenance of Self Reported Physical Function following Intervention	Changes in perceived physical function (Medical Outcomes Study Short Form-36) will be measured from intervention completion until follow-up (8 months after intervention completion)	From completion of intervention (4 months) to follow up (one year)
Maintenance of Depression following Intervention	Changes in mental health (Patient Health Questionnaire-9) will be measured from intervention completion until follow-up (8 months after intervention completion)	From completion of intervention (4 months) to follow up (one year)
Maintenance of Anxiety following Intervention	Changes in mental health (Generalized Anxiety Disorder questionnaire) will be measured from intervention completion until follow-up (8 months after intervention completion)	From completion of intervention (4 months) to follow up (one year)
Health Care Contacts	Combined measure of number of Emergency Department visits and overnight hospitalizations	One year period starting at intake assessment

Collaborators and Investigators

• Sponsor: University of Vermont Medical Center
• Collaborators: National Institute of General Medical Sciences (NIGMS)

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2021
• Primary Completion (Actual): December 1, 2023
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 31, 2020
• First Submitted That Met QC Criteria: December 31, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Secondary Prevention, Women's cardiovascular disease, case management
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: STUDY00001090; P20GM103644 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No