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CompletedNCT04693988Updated Jul 7, 2026Results posted

Early Case Management on Recovery From a Cardiac Event in Women

An interventional study of Case Management in Cardiac Rehabilitation, sponsored by University of Vermont Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by University of Vermont Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
114
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

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Conditions studied

  • Cardiac Rehabilitation

Keywords

  • Secondary Prevention, Women's cardiovascular disease, case management
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In context

Lead sponsor

University of Vermont Medical Center is the lead sponsor of 41 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
114 participants (actual)

Study arms

  • Experimental
    Case management

    Patient receives case management while in hospital.

    Behavioral: Case Management

  • No intervention
    Usual Care

    This control condition does not receive intervention of case management

Interventions

  • BehavioralCase 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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What researchers measure

Primary outcomes

  1. Attendance at CR

    Did the participant attend at least one session of CR within 4 months

    Time frame: Within 4 months of discharge

Secondary outcomes

  1. Number of CR Sessions Attended

    Number of CR sessions completed within the 4 months

    Time frame: Within 4 months

07

Results

Posted Jul 7, 2026

Participant flow

Patients were enrolled at UVMMC Medical Center and Outpatient Cardiology Clinic

Participant flow — Overall Study
MilestoneCase Management InterventionUsual Care
Started5757
Completed5356
Not completed41

Outcome measures

PrimaryAttendance at CR

Did the participant attend at least one session of CR within 4 months

Time frame:
Within 4 months of discharge
Reported as:
Count of participants · Participants
Attendance at CR
ParticipantsInterventionUsual Care
Attendance at CR4143
SecondaryNumber of CR Sessions Attended

Number of CR sessions completed within the 4 months

Time frame:
Within 4 months
Reported as:
Mean · Number of sessions
Number of CR Sessions Attended
Number of sessionsInterventionUsual Care
Number of CR Sessions Attended20.2 ± 16.017.3 ± 15.0

Adverse events

Collected over 4 months, during the duration of cardiac rehabilitation participation. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Case Management0/53 (0%)0/53 (0%)0/53 (0%)
Usual Care0/56 (0%)0/56 (0%)0/56 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(Years)InterventionUsual CareTotal
Mean68.4 ± 10.1667.4 ± 10.5368.4 ± 10.3
Sex: Female, Male
Sex: Female, Male(Participants)InterventionUsual CareTotal
Female5356109
Male000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)InterventionUsual CareTotal
American Indian or Alaska Native112
Asian123
Native Hawaiian or Other Pacific Islander000
Black or African American000
White4852100
More than one race314
Unknown or Not Reported000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)InterventionUsual CareTotal
Hispanic or Latino134
Not Hispanic or Latino5253105
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)InterventionUsual CareTotal
United States5356109
Current smoking
Current smoking(Participants)InterventionUsual CareTotal
Count of participants12618
Fitness (METS)
Fitness (METS)(METS)InterventionUsual CareTotal
Mean5.7 ± 2.35.5 ± 2.85.6 ± 2.6
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Study locations

1 site
  • University of Vermont Medical Center
    Burlington, Vermont 05405, United States
09

References and documents

Study documents

  • Study protocol · Jul 12, 2017
  • Protocol and statistical analysis plan · Jul 12, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04693988
Lead sponsor
University of Vermont Medical Center
Collaborators
National Institute of General Medical Sciences (NIGMS)
Responsible party
Sherrie Khadanga (Assistant Professor of Medicine, University of Vermont Medical Center) — Principal investigator
First posted
Jan 5, 2021
Start date
Jan 18, 2021
Primary completion
Dec 1, 2023
Completion
Dec 1, 2024
Results posted
Jul 7, 2026
Last update
Jul 7, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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