Trial Outcomes & Findings for Early Case Management on Recovery From a Cardiac Event in Women (NCT NCT04693988)
NCT ID: NCT04693988
Last Updated: 2026-07-07
Results Overview
Did the participant attend at least one session of CR within 4 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
114 participants
Primary outcome timeframe
Within 4 months of discharge
Results posted on
2026-07-07
Participant Flow
Patients were enrolled at UVMMC Medical Center and Outpatient Cardiology Clinic
Participant milestones
| Measure |
Case Management Intervention
Assigned to case management intervention
|
Usual Care
Allocated to standard of care
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
57
|
|
Overall Study
COMPLETED
|
53
|
56
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Case Management on Recovery From a Cardiac Event in Women
Baseline characteristics by cohort
| Measure |
Total
n=109 Participants
Total of all reporting groups
|
Intervention
n=53 Participants
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.
|
Usual Care
n=56 Participants
Patients assigned to usual care. This control condition does not receive an intervention.
|
|---|---|---|---|
|
Age, Continuous
|
68.4 Years
STANDARD_DEVIATION 10.3 • n=40 Participants
|
68.4 Years
STANDARD_DEVIATION 10.16 • n=20 Participants
|
67.4 Years
STANDARD_DEVIATION 10.53 • n=20 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=40 Participants
|
53 Participants
n=20 Participants
|
56 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=40 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=40 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
100 Participants
n=40 Participants
|
48 Participants
n=20 Participants
|
52 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=40 Participants
|
3 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=40 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
105 Participants
n=40 Participants
|
52 Participants
n=20 Participants
|
53 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
109 Participants
n=40 Participants
|
53 Participants
n=20 Participants
|
56 Participants
n=20 Participants
|
|
Current smoking
|
18 Participants
n=40 Participants
|
12 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
|
Fitness (METS)
|
5.6 METS
STANDARD_DEVIATION 2.6 • n=40 Participants
|
5.7 METS
STANDARD_DEVIATION 2.3 • n=20 Participants
|
5.5 METS
STANDARD_DEVIATION 2.8 • n=20 Participants
|
PRIMARY outcome
Timeframe: Within 4 months of dischargeDid the participant attend at least one session of CR within 4 months
Outcome measures
| Measure |
Intervention
n=53 Participants
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.
|
Usual Care
n=56 Participants
Patients assigned to usual care. This control condition does not receive an intervention.
|
|---|---|---|
|
Attendance at CR
|
41 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Within 4 monthsNumber of CR sessions completed within the 4 months
Outcome measures
| Measure |
Intervention
n=53 Participants
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.
|
Usual Care
n=56 Participants
Patients assigned to usual care. This control condition does not receive an intervention.
|
|---|---|---|
|
Number of CR Sessions Attended
|
20.2 Number of sessions
Standard Deviation 16.0
|
17.3 Number of sessions
Standard Deviation 15.0
|
Adverse Events
Case Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sherrie Khadanga MD
Department of Medicine, Division of Cardiology, University of Vermont, Burlington, VT
Phone: 802.847.6317
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place