Early Case Management on Recovery From a Cardiac Event in Women

Cardiac Rehabilitation Clinical Trial

Official title:

Early Case Management on Recovery From a Cardiac Event in Women

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04693988
• Other study ID #: STUDY00001090
• Secondary ID: P20GM103644
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 18, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: December 2023
• Source: University of Vermont Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 113
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Rehabilitation
• Cardiovascular Diseases

Intervention

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

Locations

Country	Name	City	State
United States	University of Vermont Medical Center	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
University of Vermont Medical Center	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	Health Care Contacts	Combined measure of number of Emergency Department visits and overnight hospitalizations	One year period starting at intake assessment
Primary	Cardiac Rehabilitation Participation	Attendance of at least 1 session	within 4 months of the intake assessment
Primary	Cardiac Rehabilitation Adherence	Number of cardiac rehabilitation sessions completed out of a possible 36	within 4 months of the intake assessment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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