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Early Case Management on Recovery From a Cardiac Event in Women

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ClinicalTrials.gov Identifier: NCT04693988
Recruitment Status : Not yet recruiting
First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Sherrie Khadanga, University of Vermont Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Cardiac Rehabilitation Behavioral: Case Management Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Case Management on Recovery From a Cardiac Event in Women
Estimated Study Start Date : February 1, 2021
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Cardiac Rehabilitation Participation [ Time Frame: within 4 months of the intake assessment ]
    Attendance of at least 1 session

  2. Cardiac Rehabilitation Adherence [ Time Frame: within 4 months of the intake assessment ]
    Number of cardiac rehabilitation sessions completed out of a possible 36


Secondary Outcome Measures :
  1. Changes in Physical Activity [ Time Frame: within 4 months of the intake assessment ]
    Changes in fitness level (step count) will be measured from intake to completion of the intervention (4 months after intake)

  2. Changes in Quality of Life [ Time Frame: within 4 months of the intake assessment ]
    Changes in perceived quality of life (MacNew) questionnaires will be measured from intake to completion of the intervention (4 months after intake)

  3. Changes in Self Reported Physical Function [ Time Frame: within 4 months of the intake assessment ]
    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)

  4. Changes in Depression [ Time Frame: within 4 months of the intake assessment ]
    Changes in depression (Patient Health Questionnaire-9) will be measured from intake to completion of the intervention (4 months after intake)

  5. Changes in Anxiety [ Time Frame: within 4 months of the intake assessment ]
    Changes in anxiety (Generalized Anxiety Disorder questionnaire) will be measured from intake to completion of the intervention (4 months after intake)


Other Outcome Measures:
  1. Maintenance of Physical Activity following Intervention [ Time Frame: From completion of intervention (4 months) to follow up (one year) ]
    Changes in step count will be measure from intervention completion until follow-up (8 months after intervention completion)

  2. Maintenance of Quality of Life following Intervention [ Time Frame: From completion of intervention (4 months) to follow up (one year) ]
    Changes in perceived quality of life (MacNew questionnaire) will be measured from intervention completion until follow-up (8 months after intervention completion)

  3. Maintenance of Self Reported Physical Function following Intervention [ Time Frame: From completion of intervention (4 months) to follow up (one year) ]
    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)

  4. Maintenance of Depression following Intervention [ Time Frame: From completion of intervention (4 months) to follow up (one year) ]
    Changes in mental health (Patient Health Questionnaire-9) will be measured from intervention completion until follow-up (8 months after intervention completion)

  5. Maintenance of Anxiety following Intervention [ Time Frame: From completion of intervention (4 months) to follow up (one year) ]
    Changes in mental health (Generalized Anxiety Disorder questionnaire) will be measured from intervention completion until follow-up (8 months after intervention completion)

  6. Health Care Contacts [ Time Frame: One year period starting at intake assessment ]
    Combined measure of number of Emergency Department visits and overnight hospitalizations


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04693988


Contacts
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Contact: Sherrie Khadanga, MD 802-847-2700 sherrie.khadanga@uvmhealth.org

Locations
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United States, Vermont
University of Vermont Medical Center
Burlington, Vermont, United States, 05405
Contact: Sherrie Khadanga    802-847-2700    sherrie.khadanga@uvmhealth.org   
Sponsors and Collaborators
University of Vermont Medical Center
National Institute of General Medical Sciences (NIGMS)
More Information
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Responsible Party: Sherrie Khadanga, Assistant Professor of Medicine, University of Vermont Medical Center
ClinicalTrials.gov Identifier: NCT04693988    
Other Study ID Numbers: STUDY00001090
P20GM103644 ( U.S. NIH Grant/Contract )
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sherrie Khadanga, University of Vermont Medical Center:
Secondary Prevention, Women's cardiovascular disease, case management