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NCT04693988 · ClinicalTrials.gov registry record · NA

Early Case Management on Recovery From a Cardiac Event in Women

A NA study, sponsored by University of Vermont Medical Center.

Completed
Registry status
NA
Development phase
114
Enrollment target

NCT04693988: Completed NA study, sponsored by University of Vermont Medical Center.

NCT04693988 is a NA study that has completed, run by University of Vermont Medical Center. The registered enrollment target is 114 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04693988, a NA study, has completed, sponsored by University of Vermont Medical Center.

COMPLETED
Registry status
NA
Development phase
114 participants
Enrollment target

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, theref

Primary Outcome

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

Interventions

  • BEHAVIORAL Case Management

Trial Details

FieldValue
Enrollment Target 114 participants
Start Date 2021-01-18
Est. Completion 2024-12-01
Phase NA

What the finished NCT04693988 record still lists

NCT04693988 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 1 intervention - of which Case Management is the first listed.

NCT04693988 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04693988 about?

NCT04693988 is a clinical study titled "Early Case Management on Recovery From a Cardiac Event in Women". 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 cardi...

What is the current status of trial NCT04693988?

This trial is currently completed. It is a NA study. The enrollment target is 114 participants. The study started on 2021-01-18. Estimated completion is 2024-12-01.

What interventions are being tested in trial NCT04693988?

The interventions under investigation include: Case Management (BEHAVIORAL).

Who is sponsoring clinical trial NCT04693988?

This trial is sponsored by University of Vermont Medical Center, which has 27 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04693988's enrollment target sits among peer trials

114 811th of 2000 higher than 1,188 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04693988, the US trial registry maintained by the National Library of Medicine. NCT04693988 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.