Early Case Management on Recovery From a Cardiac Event in Women

NCT04693988 | Unknown DMC

• 2 other identifiers: STUDY00001090P20GM103644
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Changes in Physical Activity

  within 4 months of the intake assessment

• Changes in Quality of Life

  within 4 months of the intake assessment

• Changes in Self Reported Physical Function

  within 4 months of the intake assessment

• Changes in Depression

  within 4 months of the intake assessment

• Changes in Anxiety

  within 4 months of the intake assessment

Other Outcomes (6)

• Maintenance of Physical Activity following Intervention

  From completion of intervention (4 months) to follow up (one year)

• Maintenance of Quality of Life following Intervention

  From completion of intervention (4 months) to follow up (one year)

• Maintenance of Self Reported Physical Function following Intervention

  From completion of intervention (4 months) to follow up (one year)

Study Arms (2)

Case management

EXPERIMENTAL

Patient receives case management while in hospital.

Behavioral: Case Management

Usual Care

NO INTERVENTION

This control condition does not receive intervention of case management

Interventions

Case Management 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

Case management

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)
• Lives in and plans to remain in the greater Burlington, Vermont area for the next year.

You may not qualify if:

• Severe dementia
• Advanced cancer, advanced frailty, or other longevity-limiting systemic disease
• Severe life threatening ventricular arrhythmias unless adequately controlled (e.g. intracardiac defibrillator)
• Exercise-limiting non-cardiac disease such as severe arthritis, past stroke leading to paralysis
• Participation in cardiac rehab within the past year

Sponsors & Collaborators

• University of Vermont Medical Center: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Interventions

Case Management

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: December 31, 2020
• First Posted: January 5, 2021
• Study Start: January 18, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)