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临床试验/NCT04693988
NCT04693988已完成不适用

Early Case Management on Recovery From a Cardiac Event in Women

University of Vermont Medical Center2 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2021年1月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
114
试验地点
2
主要终点
Cardiac Rehabilitation Participation

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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
  • Participation in cardiac rehab within the past year

研究组 & 干预措施

Case management

Experimental

Patient receives case management while in hospital.

干预措施: Case Management (Behavioral)

Usual Care

No Intervention

This control condition does not receive intervention of case management

结局指标

主要结局

Cardiac Rehabilitation Participation

时间窗: within 4 months of the intake assessment

Attendance of at least 1 session

Cardiac Rehabilitation Adherence

时间窗: within 4 months of the intake assessment

Number of cardiac rehabilitation sessions completed out of a possible 36

Attendance at CR

时间窗: Within 4 months of discharge

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

次要结局

  • Changes in Depression(within 4 months of the intake assessment)
  • Changes in Anxiety(within 4 months of the intake assessment)
  • Changes in Physical Activity(within 4 months of the intake assessment)
  • Changes in Self Reported Physical Function(within 4 months of the intake assessment)
  • Changes in Quality of Life(within 4 months of the intake assessment)
  • Number of CR Sessions Attended(Within 4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sherrie Khadanga

Assistant Professor of Medicine

University of Vermont Medical Center

研究点 (2)

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