CompletedNot Applicable

Early Case Management on Recovery From a Cardiac Event in Women

United States114 participantsStarted 2021-01-18

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial focused specifically on women recovering from a cardiac event — given that it's now completed, has my doctor seen any of the findings, and would early case management like what was studied be relevant to my own recovery plan?
2Since the main thing this trial measured was whether women actually showed up to cardiac rehabilitation, does my doctor think attendance and engagement are barriers for me personally, and what support might help me stay consistent?
3Cardiac rehab programs can vary a lot in how they're structured — based on what this trial explored about early case management, would my doctor recommend I start cardiac rehab sooner rather than later, and what would that timeline look like for me?
4Because this was a phase 'not applicable' study focused on a care approach rather than a drug or device, can my doctor explain whether the kind of personalized support this trial tested is something already available through my current care team or hospital?
5Are there standard cardiac rehabilitation pathways my doctor would recommend right now while we wait to see if findings from completed studies like this one change the way women's recovery programs are typically run?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Attendance at CR

Timeframe: Within 4 months of discharge

Trial details

NCT IDNCT04693988

SponsorUniversity of Vermont Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-01

Results submitted2025-03-13

View on ClinicalTrials.gov More Cardiac Rehabilitation trials