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| ID | Type | Description | Link |
|---|---|---|---|
| P20GM103644 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case management | Experimental | Patient receives case management while in hospital. |
|
| Usual Care | No Intervention | This control condition does not receive intervention of case management |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Attendance at CR | Did the participant attend at least one session of CR within 4 months | Within 4 months of discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Number of CR Sessions Attended | Number of CR sessions completed within the 4 months | Within 4 months |
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Inclusion Criteria:
-
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vermont Medical Center | Burlington | Vermont | 05405 | United States |
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Patients were enrolled at UVMMC Medical Center and Outpatient Cardiology Clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Case Management Intervention | Assigned to case management intervention |
| FG001 | Usual Care | Allocated to standard of care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change. |
| BG001 | Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Attendance at CR | Did the participant attend at least one session of CR within 4 months | Posted | Count of Participants | Participants | Within 4 months of discharge |
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4 months, during the duration of cardiac rehabilitation participation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Case Management | Patient receives case management while in hospital. 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sherrie Khadanga MD | Department of Medicine, Division of Cardiology, University of Vermont, Burlington, VT | 802.847.6317 | Sherrie.Khadanga@uvmhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Protocol | Jul 12, 2017 | May 12, 2026 | Prot_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Protocol with Stats | Jul 12, 2017 | Jun 9, 2026 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D019090 | Case Management |
| ID | Term |
|---|---|
| D010347 | Patient Care Planning |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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Patients assigned to usual care. This control condition does not receive an intervention. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Current smoking | Number of participants reporting current smoking at time of hospitalization | Count of Participants | Participants |
|
| Fitness (METS) | Fitness as measured at baseline in METS | Mean | Standard Deviation | METS |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of CR Sessions Attended | Number of CR sessions completed within the 4 months | Posted | Mean | Standard Deviation | Number of sessions | Within 4 months |
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | Usual Care | This control condition does not receive intervention of case management | 0 | 56 | 0 | 56 | 0 | 56 |
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